Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Fatigue

Breast Neoplasms

Taught to perform a specific regimen for strength-training and walking exercises.

Follow usual routines of standard care but not taught to perform a specific regimen for strength-training and walking exercises; will keep record of any exercises done that are not a part of this study.

Participants will be taught to stretch a Theraband as far as your arms or legs can stretch and the proper posture for walking for exercise. The Estimated Timed-Get-Up and Go test (ETGUPGo) and a 6-minute walk test will be performed to check your level of fatigue and physical ability.

Combined Strength Training and Functional Endurance Exercise

Questionnaires taking approximately 30 minutes total to complete.

Questionnaire

Geneva Caldwell, MSN, RN

Primary Objective:

-Determine if a specific exercise regimen (combined strength training/functional endurance) reduces the level of fatigue among women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy treatment as compared to a control group.

Secondary Objectives:

* Determine if a specific exercise regimen (combined strength training/functional endurance) increases the overall ability to perform daily physical activities (ADLs) among women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy treatment as compared to a control group.
* Determine if a specific exercise regimen (combined strength training/ functional endurance) increases mobility in women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy treatment as compared to a control group.
* Determine if a specific exercise regimen (combined strength training/functional endurance) increases endurance in women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy as compared to a control group.

Cancer-related fatigue has been described as the most common and troubling side effect of cancer and cancer treatment. Researchers want to see if a strength-training and walking exercise regimen may help reduce severe fatigue and increase patients' ability to perform activities of daily living.

If you agree to take part in this study, you will complete a questionnaire, provide contact information, and participate in 1 of 2 groups. For the questionnaire, you will be asked information about your age, ethnic origin, marital status, education, exercise habits, and cancer diagnosis. It should take about 5 minutes to complete. For the contact information, you will be asked to provide the name, address, and telephone number of someone to call in case of an emergency.

After completing the questionnaire and providing the contact information, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. Participants in the exercise group will be taught to perform a specific regimen for strength-training and walking exercises. Participants in the nonexercise group will follow the usual routines of standard care but will not be taught to perform a specific regimen for strength-training and walking exercises. Participants in the nonexercise group will be asked to keep a record of any exercises that are done for the participant's personal regimen that are not a part of this study. You will have an equal chance of being assigned to either group.

All participants in this study will be asked to complete questionnaires (the Schwartz Fatigue Scale, Karnofsky Performance Scale, and the International Physical Activity Questionnaire \[IPAQ\]) in the Breast Center Clinic before beginning chemotherapy treatment. The Schwartz Fatigue Scale and IPAQ will also be completed after chemotherapy treatment. All of these questionnaires will be used to provide information about your physical activities and how much time you spend doing them. It should take about 25-30 minutes to complete all 3 questionnaires.

No matter what group you are in, after these questionnaires are completed, a physical therapist will then escort you to the exercise room located in the Physical Therapy and Rehabilitation Clinic. The therapist will perform a lymphedema (excess fluid collection) evaluation that will involve measuring the size of your arms and hands by placing a tape measure around your arms and hands at 5 different points. The lymphedema evaluation will be done at each clinic visit when you come in for chemotherapy and 2 weeks after completing your therapy. You will also be asked to complete exercise testing, the Estimated Timed-Get-Up and Go test (ETGUPGo) and a 6-minute walk test, to check your level of fatigue and physical ability. This exercise testing will be performed before you begin chemotherapy and within 2 weeks after you finish your last chemotherapy treatment. The exercise testing will be done after your chemotherapy treatment so that researchers can compare your level of fatigue and physical performance to what you were experiencing before your therapy began.

The ETGUPGo test will measure how fast you can rise from a chair, walk about 4 yards, turnaround and return to the chair, and sit down. For the 6-minute walk test the therapist will ask you to walk around in the exercise room at your own pace while the therapist counts the total time you were able to walk. Two (2) weeks after you have finished all of your treatments, you will re-take the Schwartz Fatigue Scale, Karnofsky Scale, IPAQ, ETGUPGo, and 6-minute walk test. Your exercise testing will be done in private, which means that no one other than the study staff will be allowed to enter the room while you are being tested.

If you are assigned to the group that will have a specific exercise regimen, you will be taught a strengthening and walking exercise. For the strengthening regimen, you will be taught to stretch a Theraband (material that looks like a big rubber band) as far as your arms or legs can stretch. You will be taught to perform this exercise at home. You will be able to look at pictures of these exercises in a booklet that will be provided to you. You will be asked to perform these exercises 3-5 times per week. For the walking regimen, you will be taught the proper posture for walking for exercise. You must walk at least once per day, but otherwise you may walk as often and as long as you feel like.

You will also have exercise testing. The therapist will measure the length of your arms and legs to see how much force it takes for you to stretch the rubber band beyond the length of your arms and legs. The therapist will test your current muscle strength by asking you to sit and rise from a chair, walk a certain distance, and return to the chair. You will also be asked to walk a certain distance until you get tired. The therapist will record how much time it takes you to complete both exercises (strengthening and walking).

After you begin the exercises at home, the research nurse will call you every 2 weeks and ask you how many times you performed the strengthening exercises throughout the week as well as the average amount of time you walked each day. The phone call should last about 10-15 minutes each time. You will be asked to check the box on an exercise calendar (that will be provided to you) showing which exercises you were able to perform each day.

All exercise testing will be given on the day of your routine visits to the clinic.

Your participation will be complete in this study after you perform your last exercise testing (about 2 weeks after your last chemotherapy treatment).

This is an investigational study. However, if you begin to experience some emotional distress that is directly related to this study, you may be referred for professional counseling here at M. D. Anderson in the Social Work Department. The social services staff will be available to assist you with the referral outside of the M. D. Anderson system. Up to 58 patients will take part in this study. All will be enrolled at M. D. Anderson.

Combined Strength Training and Functional Endurance Exercise Regimen on Cancer -Related Fatigue and Physical Performance

The Effects of Combined Strength Training and Functional Endurance Exercise Regimen on Cancer-Related Fatigue and Physical Performance

Self-reported score that measures subjective perceptions of fatigue in which respondents rate their experience of feeling tired. It ranges from 1 (not at all) to 5 (extremely) and describes discomforts of cancer related fatigue in four dimensions (physical, mental, emotional, and temporal) (Schwartz and Meek, 1999).

M.D. Anderson Cancer Center

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

All patients receive a pulse-controlled endurance exercise program based on the study results by O'Donovan. The individual pulse-controlled endurance exercise should be performed 3 times a week. On the basis of age, weight, sex and body fat the normal weight will be calculated. The kilocalories (kcal), which correspond to the metabolic equivalent task (MET) hour per week, will be calculated after age and gender adjustment of the normal weight. The endurance exercise will be increased gradually until reaching 18 MET-hours/wk during the year of endurance exercise. Patients in arm A can perform different types of endurance exercise (bicycling, cross walking, jogging, walking, nordic walking, cross country skiing)

Patients in this arm should maintain their habitual physical activity pattern as before the diagnoses of colorectal cancer.

endurance exercise

habitual physical activity before the diagnosis

control

Martina Putz, PhD

Aleksandra Mystek, BBSc

Thomas Bauernhofer, MD

August Zabernigg, MD, Head

Sigrid Kastl, MD, Head

Andreas Petzer, MD, Head

Andreas Petzer, MD

Gerhard Hochreiner, MD

Hochreiner, MD

Johannes Andel, MD, Head

Josef Thaler, MD, Head

Josef Thaler, MD

Richard Greil, MD, Head

ABCSG C08 is a randomized, two-arm, multicenter trial to investigate the efficacy of endurance exercise following adjuvant chemotherapy in patients with colorectal cancer.

Indication: Locally advanced colorectal cancer after adjuvant chemotherapy. Evidence supporting the beneficial effects of exercise programs during chemotherapy are available, the results across studies are not entirely consistent. Additional studies are needed to determine the optimal content, intensity, and form of training programs.

Colorectal cancer is the second leading cause of cancer mortality in Western countries after breast cancer among women and lung cancer among men. About 5.000 new cases are diagnosed each year in Austria. This represents an annual incidence of 50-60 per 100.000 inhabitants. In patients with colorectal cancer stage III and in certain situations even in stage II adjuvant chemotherapy is indicated after R0 resection. Despite recent advances in adjuvant chemotherapy 20-30% of these patients still relapse. About 80% of recurrences occur in the first three years.

There is consistent evidence from several observational epidemiologic studies that physical activity reduces the risk of developing colon cancer. In recent years several observational studies even showed a reduction in relapse rate, colon cancer-specific mortality and overall mortality by physical activity in patients with colon and breast cancer. Colon cancer survivors who engaged in higher levels of physical activity experienced a 50-60% improvement in long-term outcomes compared to inactive patients. Different mechanisms for the protective effect of physical activity on colon cancer have been proposed and it is believed that the same mechanisms of physical activity are also involved in the improvement of disease outcomes in gastrointestinal cancer survivors. Physical activity leads to decrease of inflammation, decreased levels of insulin-like growth factor (IGF) and insulin, reduced transit time through the gut and increased levels of vitamin D. Factors, that are associated with a reduced risk of colon polyps, colon cancer and colon cancer mortality.

A review on the impact of various exercise programs on fatigue, found good evidence that exercise not only decreased levels of fatigue, but also increased quality of life, mood and functioning.

While there is evidence supporting the beneficial effects of exercise programs during chemotherapy, the results across studies are not entirely consistent. Additional studies are needed to determine the optimal content, intensity, and form of training programs.

Recently ABCSG has investigated the feasibility of endurance exercise after adjuvant chemotherapy in patients with locally advanced colorectal cancer in the investigator's study group (ABCSG C07 Exercise - pilot study). Results concerning compliance of patients have been considered for sample size estimations and study planning.

ABCSG C08-Exercise II: Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal Cancer

ABCSG C08 - Exercise II: Randomized Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal Cancer

currently sharing of IPDs (Individual Participant Data) is not planned in this trial

DFS is defined as the time from randomization to locoregional or metastatic recurrence or the appearance of secondary cancer or death, whichever occurs first. Recurrence may be either histologically proven or evidenced by imaging via MRI or CT. Isolated CEA evaluation will not be sufficient to determine a relapse.

RFS is defined as the time from randomization to locoregional or metastatic recurrence of colorectal cancer or death, whichever occurs first

OS is defined as time from randomization to death from any cause

Evaluation of physical activities measured by MET-hours in the domains "work", "leisure time ", "sedentary behavior" and "transporation" by Global Physical Activity Questionnaire (GPAQ) within each study arm and compared between study arms at baseline, at 3, at 6, at 12, at 24 and at 36 months

Evaluation of endurance exercise measured by MET-hours by pulse-control in arm A at 3, at 6 and at 12 months

Evaluation of performance enhancement measured by MET-hours by ergometry within each study arm (arm A at baseline, at 3, at 6 and at 12 months; arm B at baseline and at 12 months) and compared between study arms at baseline and at 12 months

Correlation of MET-hours in the domains "work", "leisure time ", "sedentary behavior" and "transporation" by Global Physical Activity Questionnaire (GPAQ) and results of endurance exercise as well as performance enhancement by ergometry (both measured by MET-hours) with DFS, RFS and OS

Evaluation of fatigue as measured by EORTC - QLQ FATIGUE CAT Theta scores compared between study arms. Score has no fixed upper and lower limit and a high score represents a high level of fatigue.

Evaluation of the emotional functioning score (based in the functional scale EF) as measured by EORTC QLQ-C30 emotional functioning (based on items) compared between study arms, where a high score for a functional scale represents a high/healthy level of functioning.

Evaluation of the standardized physical functioning score (based on the revised functional scale PF2) as measured by EORTC QLQ-C30 physical functioning compared between study arms, where a high score for a functional scale represents a high/healthy level of functioning

Evaluation of the standardized global health status/QoL score (based on the revised global health status/QoL QL2) as measured by EORTC QLQ-C30 summary score compared between study arms, where a high score for the global health status/QoL represents a high QoL.

Correlation of all patient reported outcomes explained above (fatigue, emotional functioning, physical functioning, global quality of life) with MET-hours

Evaluation of the influence of BMI on DFS, RFS and OS

Evaluation of the influence of body fat on DFS, RFS and OS

Evaluation of the influence of waist circumference on DFS, RFS and OS

Evaluation of the incidence of cardiovascular complications (myocardial infarction, stroke, newly diagnosed diabetes mellitus, newly diagnosed hypertension)

Evaluation of the incidence of physical activity related SAEs and physical activity related deaths in both arms

Evaluation of time from study start to physical activity related SAEs

Correlation of molecular and biochemical markers with DFS, RFS, OS and with physical activity. The analysis of molecular markers will depend on the markers which will be defined during the course of the study in addition to Insulin \& ILGF.

Oberösterreichische Krebshilfe

Austrian Breast & Colorectal Cancer Study Group

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Anti-Infective Agents

Ethanol

Preoperative exercise, alcohol and smoking cessation are recommended to patients.

Respiratory muscle exercise (two times a day) and walking (5000steps/day) are recommended to the patients preoperatively.

respiratory muscle exercise with inspiratory muscle trainer (two times a day)

Respiratory muscle exercise

Endurance exercise

The study to be carried out in the Istanbul Faculty of Medicine Department of Anesthesiology was planned as a randomized, prospective study. Patients who will undergo lung resection will be included in the study.

Patients were randomized into two groups: Intervention Group includes patients who are rehabilitated preoperatively (prehabilitation), Control Group includes patients who are routinely recommended preoperative exercise, alcohol and smoking cessation. Prehabilitation consists of respiratory muscle exercise and walking is recommended to Intervention Group.

Postoperative recovery will be questioned with Quality of Recovery-15 (QoR-15) on the 2nd day and 1st month. The intensive care unit admission, postoperative pulmonary complications and length of hospital stay will be recorded.

The study to be carried out in the Istanbul Faculty of Medicine Department of Anesthesiology was planned as a randomized, prospective study. Patients who will undergo lung resection will be included in the study. Patients will be informed about the study and their written consent will be obtained. Patients who do not give consent will not be included in the study.

Routine preoperative evaluation including detailed history (daily physical activity, clinical complaints at rest or exertion, if any) and physical examination will be performed on the patients. Patients were randomized into two groups: Intervention Group includes patients who are rehabilitated preoperatively (prehabilitation), Control Group includes patients who are routinely recommended preoperative exercise, alcohol and smoking cessation. Preoperative exercise, alcohol and smoking cessation are recommended to all patients. Prehabilitation consists of respiratory muscle exercise with inspiratory muscle trainer (two times a day) and walking (5000steps/day) is recommended to Intervention Group. Hospitalized patients are followed up with daily visits, and patients who are at home are followed up by phone call. All patients' induction of anesthesia and maintenance were similar.

Postoperative recovery will be questioned with Quality of Recovery-15 (QoR-15) on the 2nd day (as primary outcome) and 1st month. The duration of anesthesia, surgery duration, intensive care unit admission, postoperative pulmonary complications and length of hospital stay will be recorded.

Effects of Prehabilitation on Postoperative Recovery

Effects of Prehabilitation on Postoperative Recovery in Patients Undergoing Lung Resection

The primary aim of our study is to compare recovery of patients who have prehabilitation programme and who have not any programme by using QoR-15 questionnaire on the 2nd postoperative day.

Investigating recovery of patients by by using QoR-15 questionnaire

Investigating planned or unplanned ICU admission

Patients' pulmonary complications such as pneumonia, atelectasis, hemorrhage, emphysema, prolonged air leak, chylothorax and respiratory failure.

Istanbul University

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

Amino Acids

Sunitinib

Tyrosine Kinase Inhibitors

Tyrosine

Endurance exercise, 3 times weekly for 35-45 minutes, 12 weeks.

Fernando C. Dimeo, MD

In this randomized, controlled trial the investigators evaluate the effects of an exercise program lasting for 12 weeks on the physical performance, the cardiovascular function (24h blood pressure, rest blood pressure and hear function) and the fatigue and mood of patients with renal cell carcinoma undergoing a therapy with Sunitinib.

Exercise for Patients With Renal Cell Cancer Receiving Sunitinib

Effects of Physical Activity on the Endothelial and Cardiac Function of Patients With Renal Cell Carcinoma Receiving a Thyrosine Kinase Inhibitor (Sunitinib)

Pfizer

Charite University, Berlin, Germany

PD Dr. Fernando C. Dimeo

Behaviors and Mental Disorders

Cognitive Dysfunction

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

The patients will carry out an endurance exercise program consisting of walking on a treadmill for 30 to 40 minutes at a speed corresponding to 80% of the maximum heart rate

Counseling about exercise and behavioural techniques to reduce fatigue

Counseling

Fernando Dimeo, MD

The trial will evaluate the effects of an exercise program on the physical and cognitive performance of patients with hematological neoplastic diseases after high dose chemotherapy with stem cell support.

Patients (n = 60) will be randomized to an exercise or a control group. The randomization will be stratified for allogeneic or autologous blood stem cell transplantation. Patients in the exercise group will carry out an endurance training consisting of walking on a treadmill at a speed corresponding to 80% of the maximum heart rate. The exercise program will be carried out 3 times weekly for 8 weeks. Patients in the control group will receive counseling about exercise and behavioural techniques to reduce fatigue, but they will not participate at a structured exercise program. Physical performance (VO2max), cognitive function, mood and quality of life will be evaluated at recruitment and after 8 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combined Strength Training and Functional Endurance Exercise Regimen on Cancer -Related Fatigue and Physical Performance	NCT00421057	Breast Cancer Fatigue	Combined Streng... Questionnaire	21 Years - 60 Years	M.D. Anderson Cancer Center
Combined Strength Training and Functional Endurance Exercise Regimen on Cancer -Related Fatigue and Physical Performance	NCT00421057	Breast Cancer Fatigue	Combined Streng... Questionnaire	21 Years - 60 Years	M.D. Anderson Cancer Center
ABCSG C08-Exercise II: Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal Cancer	NCT03822572	Colorectal Carc...	endurance exerc... control	18 Years -	Austrian Breast & Colorectal Cancer Study Group
Effects of Prehabilitation on Postoperative Recovery	NCT05891340	Lung Cancer	Respiratory mus... Endurance exerc...	18 Years -	Istanbul University
Exercise for Patients With Renal Cell Cancer Receiving Sunitinib	NCT00869011	Renal Cell Carc...	Endurance exerc...	18 Years - 75 Years	Charite University, Berlin, Germany
Cognitive Function After Stem Cell Transplantation	NCT00884338	Fatigue Cognitive Impai... Stem Cell Trans...	Endurance exerc... Counseling	18 Years - 70 Years	Charite University, Berlin, Germany
Effects of Prehabilitation on Postoperative Recovery	NCT05891340	Lung Cancer	Respiratory mus... Endurance exerc...	18 Years -	Istanbul University
Cognitive Function After Stem Cell Transplantation	NCT00884338	Fatigue Cognitive Impai... Stem Cell Trans...	Endurance exerc... Counseling	18 Years - 70 Years	Charite University, Berlin, Germany
Effects of Prehabilitation on Postoperative Recovery	NCT05891340	Lung Cancer	Respiratory mus... Endurance exerc...	18 Years -	Istanbul University
Cognitive Function After Stem Cell Transplantation	NCT00884338	Fatigue Cognitive Impai... Stem Cell Trans...	Endurance exerc... Counseling	18 Years - 70 Years	Charite University, Berlin, Germany
Exercise for Patients With Renal Cell Cancer Receiving Sunitinib	NCT00869011	Renal Cell Carc...	Endurance exerc...	18 Years - 75 Years	Charite University, Berlin, Germany

Spots Global Cancer Trial Database for endurance exercise