Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

This single-arm feasibility trial will evaluate the administration of an aggressive exercise regimen.

The Bruinicks-Osteretsky Test of Motor Proficiency Version 2 (BOT-2) will be used to measure participants' motor function. The test is norm- referenced and designed to test motor function in children and adolescents 4 -21 years of age. The motor composite score describes overall motor abilities and is comprised of fine motor control, manual coordination, body coordination, and strength and agility. We will use the total motor composite to describe overall motor function.

Gross Motor Function

Maximum isometric knee extension strength will be measured with the subject seated in an adjustable straight-back chair. The pelvis will be fixed by an adjustable strap and the knee flexed to 45 degrees. The participant will exert a maximal voluntary force until their contraction is "broken."

Knee extension strength

Hand grip strength in kilograms will be measured using a Jamar hand held dynamometer (Sammons Preston Rolyan, Nottinghamshire, UK). Participants will be seated with the shoulder at 0-10 degrees and the elbow in 90 degrees of flexion. The forearm will be positioned in neutral. Each participant will complete three trials, and the average used for analysis.

Hand grip strength

Flexibility will be measured by having the participant perform the sit and reach test. A yardstick is placed on a firm flat surface and tape is placed across it at a right angle to the 15 inch mark. The participant sits with the yardstick between the legs with legs extended at right angles to the taped line on the floor. The heels of the feet touch the edge of the taped line and are 10-12 inches apart. The participant reaches forward with both hands as far as possible, keeping the hands parallel. The best value for three trials, in centimeters, at the most distant point of the fingertips is recorded.

Flexibility

Ankle dorsiflexion active and passive range of motion will be measured with a goniometer. The goniometer is a reliable and valid measure of active and passive range of motion if the rater uses standard procedures

Ankle range of motion

Participants will complete the modified Cooper test where they walk in a corridor as fast as possible for six minutes. The distance is recorded in meters and can also be used to estimate peak V02

Aerobic capacity

Height, body mass index, waist circumference, and blood pressure will be measured.

Body composition and vital signs

Kirsten Ness, PT, PhD

Survivors of childhood leukemia have muscle weakness and impaired mobility (physical performance), a higher than expected frequency of obesity, and early mortality from cardiovascular disease. Treatment related neuropathy, cardiotoxicity and general cachexia may complicate physical performance and establish a pattern of sedentary behavior that may lead to a lifetime of inactivity. There is limited evidence that children being treated for leukemia benefit from home exercise programs during the maintenance phase of therapy, particularly in terms of muscle strength and range of motion. However, there are no established guidelines regarding the prescription of exercise for children diagnosed with leukemia. We propose to test the feasibility of an exercise intervention among children being treated for acute lymphoblastic leukemia (ALL) and hypothesize that children who participate in the exercise intervention will demonstrate improvements in gross motor function, strength, flexibility, and cardio respiratory fitness, and that they will have more favorable body composition when compared to the children who are assigned to the usual activity group.

The purpose of this trial is to determine the feasibility of an aerobic and strengthening exercise intervention trial among children during maintenance therapy for childhood ALL by evaluating participant accrual, participant compliance, and burden to the institutional staff.

We anticipate that key barriers exist which threaten the successful completion of an interventional trial of exercise within the ALL patient population. Approximately 2,500 to 3,500 children are diagnosed each year with ALL and similar numbers will enter the maintenance phase of therapy during a given year. About 22% of those diagnosed are between 5 and 8 years old. Thus accrual is limited by the small patient population but fortunately most patients with ALL receive their care at dedicated pediatric oncology institutions. Lack of interest or lack of understanding of the underlying problem of obesity and weakness among survivors in the ALL population may be additional barriers to accrual. In addition, families may be overwhelmed by the primary diagnosis of leukemia and feel that they are unable to take on additional challenges.

Compliance to a rigorous exercise regimen must be ascertained if demonstrable improvement in motor performance, body composition and cardiovascular disease risk profile are to occur. Key to this study is not only short-term compliance but designing an intervention that will promote and improve long-term rates of exercise. Barriers to compliance include length of time to complete the intervention, number of days the intervention must be administered, perceived benefit by the participant, difficulty of the intervention, inadequate demonstration of the intervention, poor understanding by the participant/parent of the importance of obesity and weakness among survivors of childhood ALL, and health issues in regard to the primary diagnosis of ALL.

We will open a feasibility study at 3 institutions dedicated to treatment of childhood cancer: St. Jude Children's Research Hospital, Oregon Health \& Science University and Vanderbilt Ingram Cancer Center .The accrual goal of this study will be a total of 20 patients. The hypothesized outcome for this aim of the feasibility study will be an accrual rate of 50% of eligible patients at a given institution.

Motor Function The Bruinicks-Osteretsky Test of Motor Proficiency Version 2 (BOT-2) will be used to measure participants' motor function. Maximum isometric knee extension strength will be measured with a hand held myometer and hand grip strength will be measured with a hand held dynamometer. Additionally, flexibility will be measured with the sit and reach test. Ankle dorsiflexion active and passive range of motion will be measures with a goniometer. Aerobic capacity will be measured with the modified Cooper 6 minute walk test. Body composition and vital signs will also be collected.

Intervention Participants will receive counseling and written material regarding the benefits of exercise and an individualized exercise instruction session based on the results of their baseline testing and their individual preferences. Each program will include ability specific stretching/flexibility, progressive resistive strengthening, and aerobic exercise. Necessary equipment for the strengthening (weights, stretch cords, elastic bands) and aerobic components will also be provided. A videotape demonstrating each exercise in the intervention will be given to the participant and their parent."

Detailed written instructions, along with a book to log exercise, will also be provided. Stickers and small toys will be provided for the parents to give to their children for completing their exercises. Participants will receive a weekly phone call from an exercise coach, to answer questions and to progress the intervention. Participants will also receive counseling and review/progression of the exercise intervention at each usual clinic visit (approximately monthly). During the pilot study, participants will continue to receive the intervention for six months, with weekly phone calls tapering to every other week after three months. The exercise coach will be available to the participant/parent as needed via phone and/or email throughout the intervention period.

Aerobic and Strengthening Exercise for Acute Leukemia

St. Jude Children's Research Hospital

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Pancreatic Neoplasms

Body Weight

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Patients planned for pancreatic resection will be included for a home-based prehabilitation program.

The home-based prehabilitation program will consist of a four-week program, where patients are expected to perform a high-intensity interval training on a home-trainer combined with functional mobility training three times a week. The program is partly supervised by a trained physiotherapist.

Home-based prehabilitation program

Nicole Hildebrand, M.D.

Allard Wijma, M.D.

Paola Costelli, PhD

Steven Olde Damink, M.D., M.Sc., PhD

Rationale: The complication rate after pancreatic resection is high, especially in elderly and physically unfit patients. Aerobic capacity, as indicated by the ventilatory anaerobic threshold (VAT) assessed by a cardiopulmonary exercise test (CPET), can be used to identify high-risk patients. Previous studies have demonstrated that exercise prehabilitation can increase aerobic capacity in patients scheduled for intra-abdominal surgery, subsequently leading to better treatment outcomes. There is limited evidence on the feasibility of a (partly) supervised home-based prehabilitation program in patients scheduled for pancreatic resection.

Objective: The primary objective of this study is to assess the feasibility of a four-week supervised home-based prehabilitation program in patients scheduled for elective pancreatic resection. Secondary objectives are to evaluate individual responses to prehabilitation on a number of secondary endpoints (no cause-effect relationship to be established).

Study design: This study is a pragmatic multicenter study with a pretest-posttest design. It will take place at the Maastricht University Medical Center+ and University Medical Center Groningen in the Netherlands, and at the 'Città della Salute e della Scienza' in Torino, Italy.

Study population: Patients planned for elective resection of a pancreatic tumor will be screened for potential eligibility. High-risk patients, identified by an oxygen uptake (VO2) at VAT ≤13 ml/kg/min and/or VO2peak ≤18 ml/kg/min, will be asked to participate.

Intervention: A total of 45 patients will participate in a four-week (partly) supervised home-based personalized exercise training program before surgery (12 sessions in total). An advanced cycle ergometer (Lode Corival, Lode BV, Groningen, the Netherlands) will be delivered at the patient's home. Three weekly sessions of high-intensity interval training on the cycle will be combined with functional task exercise training. A trained physical therapist will visit the patient at least weekly to monitor progress.

Main study parameters: The main study parameter is feasibility of the (partly) supervised home-based prehabilitation program. Hereto participation rate and reasons for non-participation will be evaluated. In participating patients, adherence/compliance, dropout rate, reasons for dropout, adverse events, patient motivation, and patient and therapist appreciation will be assessed throughout the program.

Secondary endpoints: Secondary endpoints before and after prehabilitation include aerobic capacity, muscle function, body composition, functional mobility, immune system function, perceived fatigue, quality of life, and sarcopenia. Data on patient characteristics, neoadjuvant therapy, surgical procedure, and postoperative outcomes will also be collected for explorative purposes.

As the aging population grows, the incidence of malignancies of the pancreas will also rise. Surgery is an important treatment modality; at the same time, it is a challenge (allostatic load) for the patient's homeostasis. Age- and disease-related psychophysiological changes and comorbidities affect tolerance to surgery (adaptive capacity). Prehabilitation may increase a patient's ability to cope with surgical-induced allostatic load by improving the capacity and functioning of the respiratory, cardiovascular, and/or musculoskeletal systems, and therefore lower the risk of postoperative morbidity and mortality.

About 28% of patients undergoing pancreatic resection developed a major complication (Clavien-Dindo grade III or higher), and 3.2% deceased in-hospital in the Netherlands between 2014 and 2017. Older patients, especially physically unfit patients, are more prone to complications.

Preoperative aerobic capacity has been found to have a consistent relationship with postoperative outcome in major elective intra-abdominal surgery, such as pancreatic resection. Previous studies consistently indicated that an oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) \<11mL/kg/min and/or a VO2 at peak exercise (VO2peak) \<18mL/kg/min, as determined during a cardiopulmonary exercise test (CPET), are cut-off points to identify patients that have a higher risk for postoperative morbidity and mortality. Exercise prehabilitation has been reported to be able to preoperatively increase the physical fitness of patients scheduled for elective intra-abdominal surgery, of which high-risk patients will benefit the most. Most prehabilitation programs were carried out under supervision in an outpatient clinic. Often however, patients are not able or willing to participate, for example because of travelling issues or because it is becoming 'too much'. Home-based programs are often unsupervised and lack the ability to monitor adherence of the patient, and therefore might lack effectiveness.

A personalized exercise program in a home-based setting might enhance the participation rate, motivation, and adherence of patients. This has proven to be the preferred method for previous prehabilitation programs. Although several studies investigated the effects of exercise prehabilitation before pancreatic resection and reported positive effects on preoperative physical fitness and postoperative morbidity, there is limited evidence addressing the feasibility and effectiveness of (partly) supervised home-based prehabilitation in these populations. Moreover, effectiveness has not been evaluated using sophisticated outcome measures.

In a recent study in patients planned for liver or pancreatic surgery the adherence rate of a semi-supervised home-based training program was 83%. Furthermore, it led to an increase in VO2 at the VAT of 17.8% and VO2peak of 17.2%. This leads to the hypothesis that a partly supervised home-based prehabilitation program is feasible in a high risk-group. To test this hypothesis further the study will investigate the feasibility of a (partly) supervised prehabilitation program and will focus on patients undergoing pancreatic resection.

Objectives:

The primary objective of the study is to assess feasibility of a four-week (partly) supervised home-based prehabilitation program in patients scheduled for elective pancreatic resection. This will be measured using participation rate, reasons for non-participation, adherence/compliance, dropout rate, reasons for dropout, adverse events, patient motivation, and patient and therapist appreciation.

Secondary objectives are to evaluate individual responses to prehabilitation on the secondary study parameters. Data on patient characteristics, neoadjuvant therapy, surgical procedure, and postoperative outcomes will also be collected for explorative purposes.

Study design:

This study is a pragmatic multicenter study with a pretest-posttest design. It will take place at the Maastricht University Medical Center+ and University Medical Center Groningen in the Netherlands, as well as at the 'Città della Salute e della Scienza' in Torino, Italy.

Patients planned for elective pancreatic resection will be screened for CPET by a trained oncology nurse specialist. A trained medical physiologist will perform the CPET. Patients are eligible for the study if they have an oxygen uptake (VO2) at the VAT of ≤13 ml/kg/min and/or VO2peak ≤18 ml/kg/min. Potential candidates will be given full details of the study and invited to participate. If patients give permission, they will be contacted by an investigator who provides extensive information about the study.

If patients sign informed consent, they will fill out the baseline questionnaires (perceived fatigue, quality of life, and sarcopenia), and undergo baseline testing. Baseline tests include body composition, functional mobility, questionnaires, and immune system function.

After baseline assessment an advanced cycle ergometer (Lode Corival Home+, Lode BV, Groningen, the Netherlands) will be delivered to the patient's home. A trained community physical therapist will visit the patient at home to explain correct use of the ergometer and to (partly) supervise training program. A steep ramp test will be carried out by the physical therapist. The high-intensity interval exercise training program on the cycle ergometer will be personalized based on a weekly supervised steep ramp test. Every training session on the ergometer will take 30 minutes. Next to training at the cycle ergometer, patients will complete 15 minutes of functional exercises (e.g., sit-to-stand exercises, stair-climbing, cycling, walking). The patient will be asked to perform different types of exercises, a total of 15 exercises of about 30 seconds, with 30 seconds of rest in between. The physical therapist will explain the functional exercises and supervise the patient in the first week. Based on the patient's progress in muscle function and functional mobility, which will be tested weekly using the 30-second chair stand test at the patient's home, the physical therapist will adjust the exercises weekly. Patients will be asked to train three times a week for four weeks. In the first week, the physical therapist visits three times, whereas the patient will be visited once a week in week 2, 3, and 4.

After the prehabilitation program, patient and therapist will fill out an appreciation questionnaire. The other questionnaires will be filled in again. Also, tests on aerobic capacity, body composition, functional mobility, and immune system function will be repeated.

Aerobic capacity A maximal CPET will be performed using a calibrated electronically braked cycle. Patients with contraindications for CPET due to cardiorespiratory comorbidities will not be able to participate in the study. The patient will be fitted with an electrocardiogram, as well as a calibrated respiratory gas analysis system, that will calculate breath-by-breath VO2, carbon dioxide production (VCO2), and minute ventilation. Blood pressure and peripheral oxygen saturation will be monitored. After two minutes of rest measurements, the patient starts cycling unloaded for 2 minutes. Thereafter, depending on the patient's physical fitness, the work rate will be linearly incremented with a 5, 10, 15, or 20W/min ramp protocol to ensure a test duration between eight and twelve minutes. Patients will be instructed to maintain a pedaling frequency of 80/min. Test effort will be considered maximal when the patient shows objective (heart rate at peak exercise \>95% of predicted and/or a respiratory exchange ratio at peak exercise \>1.10) and subjective (unsteady biking, sweating, facial flushing, inability to continue despite encouragement) signs of maximal effort. Perceived exertion before and directly after CPET, using a ten-point visual analog scale, will be asked. CPET interpretation will be performed by a trained and experienced medical physiologist. The ventilatory anaerobic threshold is defined as the point at which the ventilatory equivalent for oxygen and the partial end-tidal oxygen tension reached a minimum and thereafter began to rise in a consistent manner, coinciding with an unchanged ventilatory equivalent for carbon dioxide and partial end-tidal carbon dioxide tension. If this method appeared to provide uncertain results, the V-slope method will be used.

A steep ramp test will be performed on a weekly base at the patient's home under supervision of a physical therapist to assess and monitor aerobic fitness. The advanced cycle ergometer will be used for the steep ramp test. The patient will be fitted a heart rate belt around the chest (Polar Elektro Oy, Kempele, Finland) during the test. After three minutes of rest the test will start and the work rate will be increased by a constant increment of 10 W every 10 seconds in a ramp like manner. Test duration will be four to seven minutes. The pedaling frequency should be kept constant between 60 and 80 revolutions per minute. Peak exercise is the point at which there is a sustained drop in pedaling frequency from 60 revolutions per minute, despite verbal encouragement. Data will be stored for further use. A ten-point VAS will be used to ask the level of perceived exertion. The attained peak work rate (WRpeak) will be used to adjust the training protocol for the upcoming week.

Muscle function Muscle function measurement will be measured for patients in Città della Salute e della Scienza. Knee extensors torque will be recorded using an isokinetic device under isometric sub-maximal and maximal voluntary contractions. The rate of torque development will be calculated for each contraction at different submaximal amplitudes (from 20% to 80% of maximal voluntary torque). Lastly, to measure muscle fatigability, participants will perform a submaximal isometric contraction at 70% of maximal voluntary torque until task failure (the time failure typically occurs within 60 s). High-density surface electromyographic (HDEMG) signals will be recorded from the vastus lateralis and medialis muscle during all muscle contractions to record muscle fiber conduction velocity. Muscle fiber conduction velocity is an important physiological variable associated to the qualities of skeletal muscles. Furthermore, HDEMG signals will be decomposed to identify and assess the activity of a large number of motor units over a wide range of torques, providing direct evidence on the strategies used by the central nervous system to control muscle torque.

Body composition The patient's body mass and body height will be measured pre-, and post-intervention. Body mass will be measured weekly at the patient's home. To assess skeletal muscle mass and quality a single slice of the patient's abdominal CT-scan will be selected at the level of the third lumbar vertebra (L3). Scans will be analyzed using an automated segmentation system developed and validated at Maastricht University. Skeletal muscle, visceral adipose tissue, and subcutaneous adipose tissue areas will be normalized for the patient's body height to calculate the L3 index in cm2/m2. Skeletal muscle radiation attenuation will be assessed by calculating the average Hounsfield Units value of skeletal muscle mass.

Functional mobility Functional mobility will be assessed in all patients using the 30-second chair-stand test pre- and post-intervention at the hospital, and weekly at the patient's home. Additionally, a 2-minute walk test will be performed pre- and post-intervention. The 30-second chair-stand test evaluates a combination of functional mobility, balance, and lower leg muscle strength. The primary outcome is the repetitions of standing up from a sitting position and sitting back down with crossed arms within 30 seconds. The 2-minute walk test records the distance in meters that is walked within two minutes, with a walking aid if necessary.

Immunological phenotyping Given the evidence that exercise leads to changes in the innate and adaptive immune system, blood samples will be drawn pre- and post-intervention. Levels of interleukin 6, interleukin 8, and interleukin 10, as well as C-reactive protein, and tumor necrosis factor-α will be measured by multiplex analysis. Blood samples will be centrifuged, and plasma will be stored in aliquots at -80 °C until assayed for future analysis. Blood samples will be stored, for a maximum of ten years, in the biobank of the participating hospital. Future analysis must be in line with the aims of our current research; if not, informed consent must be obtained.

Questionnaires Patients will fill out the multidimensional fatigue index, a self-reporting questionnaire with 20 propositions about different dimensions and consequences of fatigue. A higher score means a higher level of perceived fatigue. Patients will also fill out the European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30), a questionnaire with 30 items in four domains developed to assess the quality of life in cancer patients. A difference to baseline of 10 points can be considered clinically relevant. The SARC-F, a five-item questionnaire on the consequences of sarcopenia will also be filled out by the patients.

Preoperative patient characteristics:

Relevant demographic data (e.g., age and sex of participants), diagnosis, American Society of Anesthesiologists score, and Charlson comorbidity index will be collected preoperatively.

Postoperative care Details on type of surgery and intraoperative outcomes will also be collected. According to standard of care, all patients will receive postoperative physical therapy after surgery in all three participating centers. Postoperative complications will be recorded for 30 days and scored according to the Clavien-Dindo classification. The 30-day readmission rate will also be recorded. Surgical outcomes will be obtained from the electronic patient record system and from patient's physical examination on the ward.

Home-based Prehabilitation in Pancreatic Resection

Feasibility of Supervised Home-based Exercise Prehabilitation in Patients Scheduled for Pancreatic Resection

Rate of eligible patients that participate in the prehabilitation program

Patient's reasons for non-participation in the prehabilitation program while being eligible

Adherence rate to the prehabilitation program

Dropout rate of the prehabilitation program

Participant's reasons for dropping out the prehabilitation program

Any undesirable experience occurring to a participant during the study, whether or not considered related to the experimental supervised home-based prehabilitation program

Patient appreciation measured via an appreciation questionnaire

Therapist appreciation measured via an appreciation questionnaire

Oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) and VO2peak

Knee extensors torque in an isokinetic device under isometric submaximal and maximal voluntary contractions

Automated segmentation of body composition on L3 level of abdominal CT-scans

European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30)

University Medical Center Groningen

University of Turin, Italy

Nicole Hildebrand

PhD-candidate HPB-Surgery

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants in the intervention group will practice soccer for 52 weeks two times weekly. A soccer instructor will be in charge of all training sessions. The training will consist of 30 min of warm-up exercises (running, dribbling, passing, shooting, balance and muscle strength exercises), followed by 2 x 15 minutes of 4-7 a-side games.

Training will take place on a natural grass pitch. In adverse weather conditions (i.e., \< 5°C or heavy rain) training will be performed indoors. Participants will be told to avoid hard tackles and other actions that carry a risk of injury.

Participants in the control group will receive verbal advice about the benefits of exercise and physical activity.

The training will consist of 30 min of warm-up exercises (running, dribbling, passing, shooting, balance and muscle strength exercises), followed by 2 x 15 minutes of 4-7 a-side games.

Training will take place on a natural grass pitch. In adverse weather conditions (i.e., \< 5°C or heavy rain) training will be performed indoors

Football fitness

Late effects of breast cancer treatment are widely reported including deteriorating fitness, fatigue, loss of muscle and bone mass, and increased body fat percentage. Exercise interventions may ameliorate a number of these effects including fatigue, fitness and improve quality of life. However only limited knowledge exists on the potential of novel interventions and settings, such as sports outside the hospital setting, to improve late effects of breast cancer treatment. The 'Football Fitness After Breast Cancer' (FF ABC) study is a randomized trial comparing the effects of a football training intervention with standard treatment approaches on fitness, bone mineralization, body composition, muscle strength, blood pressure, and patient-reported outcomes in women treated for breast cancer.

1/3 of participants will be randomly allocated to the control group and 2/3 of participants will be randomly allocated to the Football fitness intervention group.

Personnel assessing the primary outcome is blinded for study participants group allocation.

Football Fitness After Breast Cancer

A Randomized Controlled Trial to Investigate the Health Promoting Effects of a Football Fitness Intervention for Women After Treatment for Breast Cancer

Incremental test to exhaustion on a cycle ergometer.

Assessed by dual energy x-ray absorptiometry.

Body weight was measured with a digital platform scale.

Dynamic concentric muscle strength for the knee extensors (1RM).

Blood pressure will be measured with a digital sphygmomanometer.

Procollagen type I C propeptide, osteocalcin and C-terminal telopeptide will be analyzed by a chemiluminescence method using a fully automated immunoassay system (iSYS, Immunodiagnostic Systems Ltd., Boldon, England.

Blood samples will be analyzed at baseline, 6 and 12 month for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, and glycosylated hemoglobin, respectively, by automated analyzers (Cobas Fara, Roche, Neuilly sur Seine, France) using enzymatic kits (Roche Diagnostics, Mannheim, Germany, and Tosoh G7, Tosoh Europe, Tessenderlo, Belgium).

Assessed by the International Physical Activity Questionnaire (IPAQ).

Assessed by the supplement EORTC QLQ-BR23.

Assessed by the 15 subscales of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).

Assessed by disabilities of the arm, shoulder and hand (DASH).

Assessed by The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)

University of Southern Denmark

University of Copenhagen

Postdoc

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Healthy adolescents aged 14-24 who have not been diagnosed with any chronic disease

Adolescents between the ages of 14-24 diagnosed with Polycystic Ovary Syndrome according to the Rotherdam criteria.

Ebru Calik Kutukcu, PhD

Polycystic Ovary Syndrome (PCOS) is associated with hyperandrogenism, hyperinsulinemia and insulin resistance starting in the perimenarchal period. Insulin resistance also increases the risk of developing glucose intolerance, type 2 diabetes, hypertension, dyslipidemia and cardiovascular disorders. Studies on adult women with PCOS show that their aerobic capacity is affected. Therefore, in this study; it was aimed to compare the physical and cardiovascular fitness levels of adolescent PCOS patients with healthy adolescents.

Polycystic Ovary Syndrome (PCOS) is associated with hyperandrogenism, hyperinsulinemia and insulin resistance starting in the perimenarchal period. Insulin resistance also increases the risk of developing glucose intolerance, type 2 diabetes, hypertension, dyslipidemia and cardiovascular disorders. Studies on adult women with PCOS show that their aerobic capacity is affected. Therefore, in this study; it was aimed to compare the physical and cardiovascular fitness levels of adolescent PCOS patients with healthy adolescents.Total fat and muscle ratios will be measured with the bioelectrical impedance test (BIA) instrument for body composition evaluation of individuals in both groups. Body mass index (BMI), waist/hip and waist/height ratios will be recorded. The level of cardiovascular fitness will be evaluated with the PACER test, which is among the Fitness Gram Test Protocol. For physical fitness level, muscular strength parameter will be evaluated with hand dynamometer and knee extensor muscle strength, and muscular endurance parameter will be evaluated with sit-up and push-up tests. Participants' physical activities will be evaluated with the Adolescent Physical Activity Questionnaire (PAQ-A).The quality of life of individuals with PCOS will be evaluated with the Polycystic Ovary Syndrome Quality of Life-50 Scale.

Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS

Comparison of Aerobic Capacity and Physical Fitness Level of Adolescents With Polycystic Ovary Syndrome and Healthy Peers

PACER running test, which is included in the fitnessgram test protocol, will be used to evaluate aerobic capacity.

The Fitnessgram Test Protocol will be used for physical fitness assessment.

With the Lafayette Manual Muscle Test System Model01165, knee extensor muscle strength will be measured in individuals in sitting position and knee extension. 3 repetitions will be applied for the right and left sides and the results will be recorded in kilograms.

Adolescent Physical Activity Questionnaire (PAQ-A) will be administered to both groups. This questionnaire is designed to assess physical activity in the last 7 days. It consists of 8 questions in which the answers given are scored between 1 and 5, and 9 questions questioning the existence of a situation that prevents physical activity in the last week.

The quality of life of individuals with Polycystic Ovary Syndrome will be evaluated with the Polycystic Ovary Syndrome Quality of Life-50 Scale. This scale consists of six parameters including psychosocial and status, fertility, sexual function, obesity and menstrual irregularity, hair growth and coping with the disease, and includes 50 questions. When calculating the total score and sub-dimension scores of the scale, it is scored as 5 never, rarely 4, sometimes 3, often 4, always 1.

Body fat percentage (%), body muscle percentage (%), body water percentage (%), body fat weight (kg), body muscle weight (kg) will be recorded according to Bioelectrical Impedance Analysis.

Dr. Sami Ulus Children's Hospital

Hacettepe University

Associate Professor

Patients in the Exercise group will follow a fully-supervised exercise routine (Reduced-exertion, high-intensity interval training (REHIT)) with 3 weekly 10-minute training sessions consisting of easy cycling interspersed with 2 brief 'all-out' cycle sprints. Patients in this group will also be offered up to 6 sessions of cognitive behavioral therapy. The duration of the intervention will be the weeks between enrolling in the study and surgery (\~1-4 weeks), as well as an additional period of up to 6 weeks following surgery.

Patients allocated to the Standard Care group will receive the care they would have also received if they would not have participated in the study. They will however undergo the same testing sessions as patients in the Exercise group.

Reduced-exertion, high-intensity interval training (REHIT)

Up to six 30/40-minute sessions of face-to-face psychotherapy will be offered based on a cognitive model of adjustment to cancer utilizing cognitive and behavioral therapy techniques as described by Moorey \& Greer (2012)

Cognitive behavioral therapy (CBT)

Niels BJ Vollaard, PhD

Treatment of cancer patients should not only involve removing the cancer, but should also focus on maintaining good health and well-being and quality of life. This can be done by offering patients suitable rehabilitation programmes. Previous research has shown that such programmes need to involve exercise alongside other components, such as psychological support. To date most studies have looked at the positive effects of moderate-intensity exercise such as brisk walking, but this type of exercise is time-consuming and often not done by many patients. Shorter-duration exercise routines consisting of repeated short sprints have been found to improve general health just as well, but one of the most time-efficient routines (termed 'reduced-exertion high-intensity interval training', or 'REHIT') has not been studied in cancer patients. REHIT involves 3 exercise sessions per week, each only 10 minutes long. This makes it an ideal routine to combine with other components of a cancer rehabilitation programme. The present study will determine whether REHIT can improve important markers of health and well-being in newly diagnosed breast cancer patients. To achieve this the investigators will recruit up to 30 patients and divide them into a group who will do REHIT before and for up to 6 weeks after their cancer surgery, and a control group who will receive standard care. Markers of health and well-being will be measured at the start of the study, \~1 week after surgery, and \~7 weeks after surgery. Any changes will be compared between the exercise group and the control group. If beneficial effects are found with the REHIT intervention then this could be more widely implemented as part of cancer treatment. This study is funded by Nuffield Health and will be performed in Oxford, UK.

This study involves a randomised controlled trial: study participants will be randomly allocated to either a group who will receive the care that they would normally have received if they would not have been in the study (control group), and a group who will receive the same standard care but will also be asked to follow a novel supervised exercise routine three times per week before their surgery and for up to 6 weeks after surgery, as well as some psychological support.

Up to 30 newly-diagnosed female breast cancer patients will be recruited. Following written informed consent, participants will be invited for a baseline testing session. This will involve a fasting blood sample (ideally at a time when the patient's medical team would take a blood sample anyway). The investigators will analyse this sample for a number of markers of health, such as blood sugar and fat levels, and markers of inflammation. The investigators will measure the patients' height with a stadiometer, and weight and body fat percentage using a special set of scales. The investigators will ask patients to complete several questionnaires that ask questions about their current well-being. Finally the investigators will measure the patients' handgrip strength as well as their fitness levels. The grip strength test involves squeezing a handheld device as hard as possible for a few seconds. The fitness test involves cycling on a stationary bike with a gradually increasing resistance until the patient cannot continue any longer because of fatigue. In this test the investigators will ask patients to breathe through a tube to determine the maximal amount of oxygen they can take up during exercise. This measure (termed VO2max) is one of the best health markers that can be measured: it is the best predictor of future risk of chronic disease or premature death. All testing sessions will be performed at the Manor Hospital in Oxford (unless the equipment required for the analysis of VO2max is not available for a period of time, in which case patients will be invited to attend Oxford Brookes campus for the fitness test; this is a 4-minute drive from the Manor Hospital).

Ideally, the blood samples will be taken in a fasted state (i.e. in the morning without having had breakfast), whereas the fitness test will be done after the patient has last had some food. The investigators will therefore provide the participants with a light snack after the blood sample has been taken. In case a patient cannot attend the hospital in the morning in a fasted state then they will arrange the session at a later time of day and the patient will not be required to be fasted (leading to loss of some of the secondary outcome measures which require a fasted state).

After the baseline testing has been completed the investigators will tell patients whether they will be in the control group or in the exercise group. Patients in the control group will receive their standard care as if they would not have participated in the study. The research team will not interact with these patients until the second testing session. Patients in the exercise group will be invited to perform 3 fully supervised exercise sessions per week at the Manor Hospital. These exercise sessions will involve 10 minutes of cycling at a low intensity, but with 2 brief cycle sprints after 2 and 6 minutes. The sprints will last 10 seconds in the first week of training, 15 seconds in the second week, and 20 seconds from week 3 onward. Training sessions will be stopped at least 2 days prior to the scheduled surgery date.

Surgery will interrupt the exercise programme. Between 7 and 10 days post-surgery, or when the consultant breast surgeon deems appropriate, all patients will undergo post-surgery testing. Testing procedures will be identical as those for baseline testing.

Following post-surgery testing, patients in the exercise group will resume the exercise programme. The duration of the sprints will restart at 10 seconds in the first week, 15 seconds in the second week, and 20 seconds in the remaining weeks. The exercise routine will be continued until follow-up treatment or for a period of up to 6 weeks. Before or after one of the 3 weekly exercise sessions, patients will receive a 30/40-minute face-to-face session with a psychologist. The aim of these sessions will be to reduce emotional distress, improve mental adjustment, promote a sense of personal control over current experience, develop effective coping strategies for dealing with cancer-related difficulties, and open expression of emotion. If patients cannot attend psychological support sessions then they will be offered the opportunity to catch up through a session over the phone.

Approximately 3 days following the final training session patients will undergo end-of-trial testing, identical to the previous two testing sessions. Patients in the control group will undergo this testing session at a time-point equivalent to that of patients in the exercise group.

Health Benefits of HIT for Breast Cancer Patients

The Efficacy of Reduced-exertion High-intensity Interval Training for Improving Health and Well-being in Newly Diagnosed Female Breast Cancer Patients

This is a small study which will generate pilot data for larger trials. Although the investigators will publish group data there is no plan to share individual data with other researchers. However, any requests for anonymised individual data will be considered on a case-by-case basis.

VO2max is a measure of the maximal amount of exercise that can be consumed and used during exercise. It is one of the best predictors of future risk of morbidity and mortality. An increase in VO2max represents a positive change in health. The primary outcome measure is change in VO2max from baseline to 1 week post-surgery and 7 weeks post-surgery.

HOMA-IR is a measure of risk of type 2 diabetes and metabolic disease.

This includes circulating levels of total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides. These are common health markers.

Blood pressure is a common health marker.

Height and weight will be measured to calculate BMI (in kg/m\^2). BMI is a common health marker.

Maximal isometric grip strength assesses how hard a person can squeeze their fist. This is a good marker of risk of future morbidity.

Questionnaires will be used to determine changes in mental well-being.

Body fat percentage (as determined using bioimpedance scales) is a common health measure.

University of Bath

Oxford Brookes University

University of Stirling

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Quality of Life

After pre-test, the intervention participants received a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual.

The intervention participants also received a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers.

Participants in the control group received regular medication education.

After pre-test, the intervention participants received a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participants also received a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers.

Home rehabilitation exercise program

Tsae Jyy Wang, PhD

Aim: To develop and testing a home exercise program for lung cancer survivors to improve their exercise tolerance and quality of life during the rehabilitation phase.

Design: An experimental design will be used in the study. The 90 lung cancer survivors, who were diagnosed with lung cancer within one year and have completed their initial cancer treatment, will be recruited and randomized to the control or intervention group. After pre-test, the intervention participants will receive a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participant will also receive a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers. The similar outcome measures as study one will be assessed on the baseline, 1th month, 3th month, and 6th month.

Measurements: The study outcomes will be evaluated by three physical measures, six-minute walk test, Modified Borg Scale, 30-second Chair Sit-to-Stand Test, and 30-second Chair Sit-to-Stand Test, as well as a study questionnaire including Functional Assessment of Cancer Therapy-Lung (FACT-L) and FACIT-Fatigue. For study one the following data will be collected from the patient'schart: post-operative pulmonary complications, days of chest tube insertion, and days of hospitalization.

Data analysis: Descriptive analysis will be used to describe patients'demongraphics, disease variables, and outcome variables. The Chi-square, T-test, and General Linear Mix-effect Model will be used to test the efficacy of the study interventions.

Background: With appropriate treatment, lung cancer patients can be a long-term survivor. However, many patients suffered from post-operative pulmonary complications, limited activity tolerance, and poor quality of life. Nurses in a great position to provide individualized health education regarding exercise for these patients; therefore to develop and test cost-effective nurses-lead lung rehabilitation exercise education programs deserver further scientific efforts.

Aim: To develop and testing a home exercise program for lung cancer survivors to improve their exercise tolerance and quality of life during the rehabilitation phase.

Design: An experimental design will be used in the study. The 90 lung cancer survivors, who were diagnosed with lung cancer within one year and have completed their initial cancer treatment, will be recruited and randomized to the control or intervention group. After pre-test, the intervention participants will receive a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participant will also receive a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers. The similar outcome measures as study one will be assessed on the baseline, 1th month, 3th month, and 6th month.

Measurements: The study outcomes will be evaluated by three physical measures, six-minute walk test, Modified Borg Scale, 30-second Chair Sit-to-Stand Test, and 30-second Chair Sit-to-Stand Test, as well as a study questionnaire including Functional Assessment of Cancer Therapy-Lung (FACT-L) and FACIT-Fatigue. For study one the following data will be collected from the patient'schart: post-operative pulmonary complications, days of chest tube insertion, and days of hospitalization.

Data analysis: Descriptive analysis will be used to describe patients'demongraphics, disease variables, and outcome variables. The Chi-square, T-test, and General Linear Mix-effect Model will be used to test the efficacy of the study interventions.

Significance: The study results will provide evidence for the efficacy of pulmonary rehabilitation and a home exercise program for enhancing exercise tolerance and quality of life in lung cancer survivors.

A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors

The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.

To measure upper body strength and endurance. The participant is sitting on the edge of a stabile chair, with seat height of 44 cm (originally 43.18 cm). The back is outstretched, the feet resting flat on the ground. A handle weighing 2 kg for women or 3.5 kg for men is held in the dominant hand. The arm is directed downwards, along the chair, perpendicularly to the floor. Participant's task is, at a command given by the testing person, to rotate the hand upwards while simultaneously flexing the extremity in the elbow (flexion with supination), and subsequently to extend the extremity to its baseline position.

To test leg strength and endurance. Record the number of stand a person can complete in 30 seconds.

There are two subscales, 27 items of FACT-General and 9 items of Lung Cancer Subscale. Each item is rated on a 5-point Likert scale (0-4). The total score of the 36 items represents the score of the scale. The higher values represent better quality of life.

There are 13 items in the scale. Each item is rated on a 5-point Likert scale (0-4). The total score of the 13 items represents the score of the scale. The possible score for the scale ranges from 0 to 52. The higher values represent more fatigue.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Aerobic and Strengthening Exercise for Acute Leukemia	NCT00766311	Acute Lymphobla...	Gross Motor Fun... Knee extension ... Hand grip stren... Flexibility Ankle range of ... Aerobic capacit... Body compositio...	5 Years - 10 Years	St. Jude Children's Research Hospital
Home-based Prehabilitation in Pancreatic Resection	NCT05496777	Preoperative Ph... Aerobic Capacit... Aerobic Fitness Functional Mobi... Cancer Weight, Body Cancer of Pancr...	Home-based preh...	18 Years -	Academisch Ziekenhuis Maastricht
Football Fitness After Breast Cancer	NCT03284567	Breast Neoplasm...	Football fitnes...	18 Years - 75 Years	University of Copenhagen
Football Fitness After Breast Cancer	NCT03284567	Breast Neoplasm...	Football fitnes...	18 Years - 75 Years	University of Copenhagen
Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS	NCT05246306	Polycystic Ovar...		14 Years - 24 Years	Hacettepe University
Health Benefits of HIT for Breast Cancer Patients	NCT03176888	Breast Cancer	Reduced-exertio... Cognitive behav...	35 Years - 60 Years	University of Stirling
Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS	NCT05246306	Polycystic Ovar...		14 Years - 24 Years	Hacettepe University
Football Fitness After Breast Cancer	NCT03284567	Breast Neoplasm...	Football fitnes...	18 Years - 75 Years	University of Copenhagen
A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors	NCT03918538	Lung Cancer	Home rehabilita...	20 Years -	National Taipei University of Nursing and Health Sciences
A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors	NCT03918538	Lung Cancer	Home rehabilita...	20 Years -	National Taipei University of Nursing and Health Sciences

Spots Global Cancer Trial Database for aerobic capacity