Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

In the 8-week exercise training, the exercise resistance of the patients will start with 60-70% according to1 Repetition Maximum in the first 4 weeks and will be increased to 70-80% according to 1 Repetition Maximum in the last 4 weeks according to the American College of Sports Medicine safe exercise intensity guideline for elderly individuals.

In the 8-week exercise training, the exercise resistance of the patients will start with 60-70% according to 1 Repetition Maximum in the first 4 weeks and will be increased to 70-80% according to 1 1 Repetition Maximum in the last 4 weeks according to the American College of Sports Medicine safe exercise intensity guideline for elderly individuals.

In the 8-week exercise training, the exercise resistance of the patients will start with 60-70% according to 1 Repetition Maximum in the first 4 weeks and will be increased to 70-80% according to 1 Repetition Maximum in the last 4 weeks according to the American College of Sports Medicine safe exercise intensity guideline for elderly individuals.

Patients will be given a visual brochure with pictures explaining the exercises. Patients will perform the resistance exercises in the given exercise program for 8 weeks, 2 days a week for 8-12 repetitions and 3 sets using resistance bands.Progress of the home exercise group will be checked by phone every week.

Home based exercise

A video recording of the exercises will be taken and given to the patients as a video recording.Patients will perform the resistance exercises in the given exercise program for 8 weeks, 2 days a week for 8-12 repetitions and 3 sets using resistance bands.Progress of the video-based exercise group will be checked by phone every week.

Video-based resistive exercise

Patients will perform their exercises under the supervision of a physiotherapist.Patients will perform the resistance exercises in the given exercise program for 8 weeks, 2 days a week for 8-12 repetitions and 3 sets using resistance bands.

Supervised resistive exercise

Özlem Feyzioğlu, PhD

Selvi Dinçer, Associate Professor

The aim of this study was to compare the effects of video-based application method of resistance exercise training and supervised exercise training on mobility, body composition, quality of life, fatigue, muscle strength and physical performance in patients with prostate cancer receiving androgen deprivation therapy treatment.

Comparison of the Effectiveness of Supervised, Video-based and Home-based Resistance Exercise Program in Patients With Prostate Cancer

Muscle strength of the patients' reference muscles gluteus maximus, quadriceps, hamstring, gastrocsoleus, gluteus medius, shoulder abduction, biceps, triceps, shoulder flexion will be evaluated with Hand Held dynamometer.For each muscle group, 3 measurements will be made at 1 minute intervals and the average of the measurements will be accepted as the evaluation result.

Total body fat mass, will be measured using Dual-Energy Xray Absorptiometry (DEXA) at baseline and after treatment in kilograms.

Total body fat percentage, will be measured using Dual-Energy Xray Absorptiometry (DEXA) at baseline and after treatment in percentile.

Total body fat mass, will be measured using Dual-Energy Xray Absorptiometry (DEXA) at baseline and after treatment in BMI in kg/m\^2.

The physical performance level of the patients will be assessed with the short physical performance battery, which is a combined test that includes a chair stand test along with gait speed and balance assessment. The maximum score is 12 and a score of ≤8 indicates poor physical performance.

FACT-P is a scale that assesses the quality of life of patients with prostate cancer. The 27-question general version consists of sections assessing emotional, social or family, physical and functional status. There are 12 questions about the treatment of patients with prostate cancer and additional concerns. The lowest score is 0 and the highest score is 156. A high score indicates good quality of life.

Grip strength was evaluated by hand grip dynamometry. Measurements were performed in affected side according to positions defined by American Society of Hand Therapists (sitting with the shoulder adducted to the side and the elbow flexed 90° with the forearm and wrist in the neutral mid-position)

FACIT-F consists of 13 questions assessing the level of fatigue during daily activities in the last week. The maximum score is 52. A high score indicates a high level of fatigue. It is a Likert-type scale scored between 0-4.

Sarcopenia Risk Survey is a 5-item questionnaire self-reported by patients as a screening for sarcopenia risk. It assesses 5 components: strength, supported walking, getting up from a chair, climbing stairs and falling. Scoring for each component ranges from 0-2, with a total score of 0-10. A score of 4 or more indicates sarcopenia.

The Hospital Anxiety and Depression Scale (HADS) Anxiety and depression levels of the patients will be evaluated with the HADS questionnaire.This scale has subscales for anxiety and depression. It includes a total of 14 questions. Seven items measure anxiety and the other seven items measure depression. The lowest score is "0" and the highest score is "21". An increase in the total score indicates an increase in the level of anxiety and depression.

Acibadem University

Asistant Professor

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Osteosarcoma

Sarcoma

Sarcoma, Ewing

Chondrosarcoma

Bone Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Bone Diseases

Soft Tissue Sarcoma

Ewing Sarcoma

alida abbruzzese

matilde meneghini

The objective of this study is to describe adherence to a personalised home exercise program in patients undergoing resection and reconstruction of lower limb for bone tumor and neoadjuvant chemotherapy treatment in the first six months after surgery intervention and investigate possible prognostic factors.

In cancer patients undergoing adjuvant therapies, rehabilitation plays an important role in reducing the side effects of chemotherapy treatment by promoting cardiorespiratory function, reducing fatigue and improving quality of life. Physiotherapy treatment, generally, includes physical training programs administered in many ways, not yet well standardized. With the aim of seeking an empowerment of the patient and his active participation, more and more exercise programs are used that the patient is able to manage independently. Adherence to and compliance with such exercise programs is extremely variable in literature and can range from 52% to 89%. A high level of adhesion is a well-known challenge and a fundamental prerequisite for achieving the benefits of physical activity. Home exercise programs to be performed in complete autonomy have been proposed in patients with different types of cancer, while for patients with bone tumor, to date there are no experiences. In this group of patients the role of physiotherapy is significant not only to counteract the adverse effects of chemotherapy treatment but also to promote the recovery of patients following the important resection and reconstruction interventions. In this type of patient, a high adherence to the physiotherapy treatment started already during the periods of hospitalization for the administration of antiblastic treatment.

Data will be collected from all patients treated consecutively over two years according to the defined inclusion criteria. Given the rarity of oncologic pathology of the musculoskeletal system and the limited number of patients of 27 found to meet the inclusion criteria in the year 2021, it is assumed that data will be collected from a sample of 50 patients.

The variables collected will be: age, sex, BMI, smoking, physical activity level, diagnosis, metastasis at diagnosis, type of surgery, chemotherapy treatment.

Data will be described by mean and standard deviation or median and interquartile range values according to the nature of the data and frequency and percentage for dichotomous variables

The objective of this study is to describe adherence to a personalised home exercise program in patients undergoing resection and reconstruction of lower limb for bone tumor and neoadjuvant chemotherapy treatment in the first six months after surgery intervention and investigate possible prognostic factors.

Adherence to a Personalized Home Exercise Program in Patients With Bone Tumor Undergoing Lower Extremity Salvage Surgery

Treatment Adherence to a Personalized Home Exercise Program in Patients With Bone Cancer Undergoing Lower Extremity Resection and Reconstruction

every day the patient will record the exercise execution/not-execution

The TESS is a self-administered questionnaire evaluating possible limitations in physical activity. A total of 30 questions are included in the TESS, and the degree of disability is rated from 0 (complete disability) to 5 (no functional impairment) in each item. Similar to MSTS for lower extremity, the final TESS score is converted to a score ranging from 0 to 100 points. If a question in TESS score does not apply to the patient, the last can respond "not applicable."

Timed up and go is a simple test to measure a person's mobility level and requires static and dynamic balancing skills. It consists of measuring how many seconds it takes the patient to get up from the chair, walk a distance of 3 meters, turn around, return to the chair and sit down again.

will be investigated with a questionnaire consisting of a likert scale of 4 questions with score from 0 (not at all satisfied) to 5 (completely satisfied).

Istituto Ortopedico Rizzoli

This intervention arm will include 3 group, supervised sessions per week for 6 months with a certified exercise specialist. Supervised sessions will be delivered in a group format with 4-8 participants per group. Flexibility training will include stretching for 5-10 minutes at the beginning and end of each session. Aerobic training will involve 30 minutes of low-impact step aerobics. Resistance training will be conducted using resistance bands, a stability ball, and an exercise mat with 8 prescribed exercises that target the major muscle groups. Participants will be encouraged to perform exercises independently on additional days, for a total of 4-5 days per week of exercise.

The same protocol and training frequency as the supervised programs described above will be followed. However, all exercises will be completed independently by participants. Specific exercises in the aerobic program may be modified to accommodate patient preference (same target heart rate range as the supervised group). Participants will be supported with smartphone technology and remote 'health coaches' during the intervention phase. This will help to ensure participant adherence, appropriate progression, and safety.

The exercise program will be delivered in a group format (4-8 participants per group) by a certified exercise specialist.

Supervised Group Exercise

The exercise program will be executed independently by participants in a home-based setting. Home-based participants will be supported with remote health coaching and smartphone technology.

Home Based Exercise

Prostate Cancer (PC) affects 1 in 7 men. Nearly half of those diagnosed with PC will receive androgen deprivation therapy (ADT) as part of their treatment. ADT is good at managing PC but has many side effects. Researchers have shown that exercise, specifically one-on-one supervised exercise improves many of the side effects of ADT. However, exercise programs for men on ADT are not widely available. More questions need to be answered in order for exercise programs to become part of PC treatment. First, can programs that require fewer resources, such as group-exercise or home-based exercise, also improve ADT side-effects? Second, do exercise-related benefits continue beyond the structured exercise program? And what makes people continue exercising? Third, which exercise program is most cost-effective?

In this study, the investigators will compare: (a) group supervised in-centre and (b) home-based supported exercise programs to see which program is most effective for men with PC on ADT. The investigators will also look at what motivates people to continue to exercise both during a structured program and after the program is complete and will examine which exercise program is most cost-effective.

Participants (men with PC on ADT) will be recruited from one of the following cancer centres: Princess Margaret Cancer Centre in Toronto, the Tom Baker Cancer Centre in Calgary, the Southlake Regional Health Centre in Newmarket, and Scarborough and Rouge Hospital - Centenary Site in Scarborough. When a patient agrees to participate, patient will be randomly placed in 1 of 2 exercise programs. All programs will include the same type of exercises (aerobic, resistance and flexibility) and all participants will exercise 4-5 days per week for 30 minutes per day (as tolerated) for the length of the program (6 months). The investigators will look at how men with PC on ADT respond to the exercise program by measuring quality of life (QOL), fatigue and different physical measures before, during, and after the exercise program.

Although the investigators know that supervised one-on-one exercise is most effective at improving ADT side-effects, it is unknown if other forms of exercise are just as beneficial and more financially responsible. This study will allow the investigators to begin to answer these questions so that structured exercise programs become a regular part of PC treatment.

An a priori decision was made to not include additional covariates in the ANCOVA model due to a smaller than anticipated sample size. Only trial centre, length of ADT, and baseline 6MWT will be included in the model.

In addition, we have modified the wear time criteria for accelerometry from 600 minutes of wear time to 500 minutes of wear time. This allows for the inclusion of more participant data and more accurately reflects the clinical nature of this population.

Amendment date: 17-Sep-20

ADT Exercise Trial and Economic Analysis

A Randomized Control Trial (RCT) and Economic Analysis of Two Exercise Delivery Methods in Men With Prostate Cancer on ADT

The FACT-F is a questionnaire that includes 13 items measuring cancer-related fatigue.

The 6MWT is a commonly used, validated measure that assesses functional endurance.

The FACT-G is a questionnaire that is well-validated and widely used to measure quality of life (QOL).

The FACT-P is a questionnaire that supplements the FACT-G with 12 prostate-specific items covering domains of urinary function, sexual function, pain, and related symptoms.

A common, simple, and validated measure of functional lower body strength.

Grip strength is a measure of upper body strength and predicts long-term disability and mortality in middle-aged and older adults.

Body composition will be measured using bioelectrical impedance analysis (BIA).

Body composition will be measured using waist circumference(WC) and WC:hip ratio, following the standardized Canadian Society for Exercise Physiology - Physical Activity Training for Health (CSEP-PATH) protocol.

Body composition will be measured using body mass index (BMI).

Bone mineral density will be measured at lumbar spine, hip, and distal 1/3 radius using dual x-ray absorptiometry (DXA).

Fasting lipids, blood glucose, glycated hemoglobin, hemoglobin, prostate-specific antigen (PSA), and testosterone will be measured. Serum banking will also be done for use in future studies.

Time spent in activities that are characterized by an energy expenditure ≤ 1.5 metabolic equivalents and a sitting or reclining posture (sedentary behavior) will be assessed using the Sedentary Behaviour Questionnaire that is used in large cohort studies and has demonstrated evidence of reliability and validity.

The Planning, Attitudes, \& Barriers scale is a validated questionnaire that will be used to assess likelihood of exercise behavior over time.

Behavioral Regulations in Exercise Questionnaire-2 (BREQ-2) is a validated questionnaire that assess predictors of adherence.

Relatedness will be assessed using the Psychological Need Support and Frustration Scale - Relatedness Items.

The Health Care Climate Questionnaire (HCCQ short form) assess participant perceptions of their health care team.

Participant postal codes will be collected to assess neighbourhood walkability (i.e., access to a grocery store within walking distance).

The investigators will collect economically relevant data about health status using preference-based (utility) instruments (European Quality of Life Five Dimensions Questionnaire, EQ-5D). Productivity losses and out-of-pocket expenditures, in addition to hospitalization, drug co-pay, and health visit data will be gathered using a patient questionnaire.

Both accelerometry and the Godin Leisure Time Exercise Questionnaire will be used as a measure of adherence at each time point. Both measures will provide a validated measure of physical activity.

Tom Baker Cancer Centre

Southlake Regional Health Centre

Scarborough Rouge Hospital

University Health Network, Toronto

Symptoms and General Pathology

Behaviors and Mental Disorders

Fatigue

Quality of Life

Subjects randomized to intervention will receive Physical Therapist instructed exercise teaching. They will receive a home exercise DVD and flip ring of exercises. Subjects will be asked to perform home exercise 3 days weekly consisting of 13 strengthening/stretching exercises and 20 mins of aerobic exercise, walking or seated aerobics using ergometer. Subjects will record their exercise on a log and return on day 1 of every cycle.

Subjects randomized to observation will only have physical therapy assessment using the Berg Balance Test and 6min Walk Test at baseline and end point. These subjects will not receive any exercise teaching.

Alicia S. Johnson, ADN-RN

Implementation of a home based exercise program to reduce functional decline, cancer related fatigue (CRF) and improve quality of life in the elderly gynecologic oncology patient

Problem:

Can prevention of CRF and loss of function improve QOL in the elderly gynecologic oncology patient undergoing chemotherapy?

Support:

Fatigue and its impact on QOL is a major concern with the elderly patient receiving chemotherapy. When compared to younger adults QOL is more important than gain in survival for elderly patients. (Eyigor, et al., 2010).

The National Comprehensive Cancer Network recommends exercise as the most effective intervention for cancer related fatigue.

Methods:

This is a single institution randomized controlled study to evaluate a home based exercise program in elderly gynecologic oncology patients undergoing chemotherapy. Subjects will be randomized to the intervention group or to the control group receiving usual care.

Intervention group will receive a home exercise program 3 days weekly consisting of 30mins of strength and aerobic activity, utilizing a follow along exercise DVD and patient log to assist with compliance.

The two groups will be compared by 1) objective PT assessment with the Berg Balance and 6 minute walk test (before or after) Cycle 1 and 6, 2) subjective nursing assessment with the NHANES (National Health and Nutrition Examination Survey) and FACIT- F (Functional Assessment of Chronic Illness Therapy: Fatigue) prior to Cycle 1 (baseline),4 (midpoint), and following cycle 6 (completion).

Conclusion:

PT directed home exercise program may improve CRF, functional decline, and QOL in elderly gynecologic oncology patients undergoing chemotherapy.

Home Based Exercise Program for Elderly Cancer Patients

Single Institution Randomized Controlled Study of a Home Based Exercise Program to Reduce Functional Decline, Cancer Related Fatigue (CRF and Improve Quality of Life for the Elderly Gynecologic Oncology Patient)

CRF will be evaluated using the FACIT-F tool.

QOL will be evaluated using the NHANES and FACIT-F tools.

Physical function will be evaluated using the Berg Balance Test and 6 Min Walk Test

Oncology Nursing Centers for Excellence

Duke University

Breast Neoplasms

This is a single study arm consisting of a home-based exercise program for individuals with breast or prostate cancer during active treatment.

The intervention will be based on a remote approach, lasting 12 weeks. The training routine will consist of aerobic (walking), muscle strengthening and stretching exercises, with a frequency of three days per week. The contents related to the exercise prescription will be made available by phone call, text messages and short videos for exercise demonstration.

Home based exercise training

Daniel Umpierre de Moraes, PhD

Larissa Xavier Neves da Silva, Master

Larissa Xavier Neves da Silva, MSc

The purpose of this trial is to evaluate the feasibility of a home based exercise program for individuals with breast or prostate cancer patients undergoing active treatment.

This feasibility trial aims to assess a home-based exercise program, including a 3-month intervention of structured physical activity and health education for individuals with breast or prostate cancer. The main objective of this trial is to assess the adherence of cancer patients to a program of structured exercise, mixed with a health education approach, implemented and accompanied in a remote approach.

The data collection will include variables related to: (a) recruitment and retentions rates; (b) attendance to exercise sessions; (c) fatigue and quality of life levels; (d) functional capacity levels; (e) adverse events related or not to the study; (f) patient selected outcomes.

This a feasibility trial to assess a home-based exercise intervention individuals with breast or prostate cancer during treatment.

The trial is designed for female breast cancer patients and male prostate cancer patients.

Home Based Exercise for Patients With Breast or Prostate Cancer (The BENEFIT-CA Study)

Home Based Exercise for Patients With Breast or Prostate Cancer During Treatment: a Feasibility Trial (The BENEFIT-CA Study)

Files will be as de-identified as possible before public data sharing. After data protection and data handling routines, de-identified data will be readily available to all project contributors. We consider research data gathered from data collection from research participants pertains primarily to these individuals. Therefore, all individual data will be available to their owners throughout the project. Structured data that will result from this research project will pertain to the PI (Daniel Umpierre), who will be responsible for data integrity, and to the institution (Hospital de Clinicas de Porto Alegre).

The specific structure for data sharing as well as plataforms are still to be defined. As soon, we define the remaining details of our data sharing strategy the IPD plan will be updated.

Fatigue scores using specific questionnaires of Functional Assessment of Cancer Therapy (FACT questionnaire) for breast or prostate cancer patients.

Quality of life scores using specific questionnaires of FACT (Functional Assessment of Cancer Therapy) for breast or prostate cancer patients.

Total distance (in meters) performed during the six minute walk test.

Maximum strength (in kgf) achieved by both hands in a handgrip test using a hand dynamometer.

Anthropometric measure of the highest abdominal circumference, using a metallic measuring tape.

Physical activity calculated in minutes and intensity per week, of physical activity using the International Physical Activity Questionnaire (IPAQ).

Through the development of the study, participants will be asked to engage in a focal group to discuss outcomes relevant to be assessed in trials with exercise interventions targeted for patients with breast or prostate cancer.

Proportion of self-reported exercise episodes (out of 36 episodes, total) during the study.

Proportion of included participants (who signed the informed consent) in relation to the total number of screened individuals for eligibility.

Self-reported adverse events, related or not to the study. These measures will be mostly received by phone calls or text messaging.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of the Effectiveness of Supervised, Video-based and Home-based Resistance Exercise Program in Patients With Prostate Cancer	NCT06145243	Prostate Cancer	Home based exer... Video-based res... Supervised resi...	65 Years - 80 Years	Acibadem University
Adherence to a Personalized Home Exercise Program in Patients With Bone Tumor Undergoing Lower Extremity Salvage Surgery	NCT05779670	Osteosarcoma Ewing Sarcoma Chondrosarcoma Bone Tumor		12 Years - 90 Years	Istituto Ortopedico Rizzoli
ADT Exercise Trial and Economic Analysis	NCT02834416	Prostate Cancer	Supervised Grou... Home Based Exer...	-	University Health Network, Toronto
Home Based Exercise Program for Elderly Cancer Patients	NCT01990066	Cancer Related ...	Home Based Exer...	65 Years -	Duke University
Home Based Exercise for Patients With Breast or Prostate Cancer (The BENEFIT-CA Study)	NCT05258526	Breast Cancer Prostate Cancer	Home based exer...	18 Years -	Hospital de Clinicas de Porto Alegre
ADT Exercise Trial and Economic Analysis	NCT02834416	Prostate Cancer	Supervised Grou... Home Based Exer...	-	University Health Network, Toronto
Comparison of the Effectiveness of Supervised, Video-based and Home-based Resistance Exercise Program in Patients With Prostate Cancer	NCT06145243	Prostate Cancer	Home based exer... Video-based res... Supervised resi...	65 Years - 80 Years	Acibadem University

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