None listed
Conditions
Brief summary
The primary purpose of this trial is to investigate the efficacy of progressive resistance training for reducing the side effects of loss of muscle and increase in fat associated with androgen deprivation therapy (ADT) for men with prostate cancer. Who is it for? You may be eligible to enroll in this trial if you are aged 50-80 years and have been diagnosed with prostate cancer for which you are scheduled to receive ADT by a GnRH agonist. Study details All participants enrolled in this trial will be randomly allocated (by chance) to either the progressive resistance training group or the control group, who receive no training. Participants in the progressive resistance group will receive self-managed structured 40 minute resistance exercise regimen using dumbbells 3 times a week for 12 months. It is hoped that this trial will provide information on the efficacy of progressive resistance training for reducing the loss of protein, muscle mass and function associated with ADT in prostate cancer patients.
Interventions
Progressive resistance training for 12 months.
This is a self-managed structured 40 minute resistance exercise regimen 3 times a week
with 8-10 exercises targeting the major muscle groups using adjustable dumbbells and body weight loading (i.e. calisthenics). Loads will yield 8-12 repetitions maximum per set and calisthenics exercises and loads will be advanced with strength adaptation. One week of exercise supervision (3 sessions) will be provided at baseline to instruct participants in proper
Progressive resistance training for 12 months. This is a self-managed structured 40 minute resistance exercise regimen 3 times a week with 8-10 exercises targeting the major muscle groups using adjustable dumbbells and body weight loading (i.e. calisthenics). Loads will yield 8-12 repetitions maximum per set and calisthenics exercises and loads will be advanced with strength adaptation. One week of exercise supervision (3 sessions) will be provided at baseline to instruct participants in proper lifting techniques and loading progressions by exercise phisiologist. Online instructional videos and a printed training manual will also be provided for each exercise. Follow-up supervised sessions will be provided one session every 8 weeks of the intervention. Compliance to training will be recorded in a training log by the participants.
Sponsors
Blacktown Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. ECOG less than or equal to 1; histologically confirmed prostate cancer of early or locally advanced stage, or metastatic prostate cancer with bone involvement only (less than or equal to 5 sites of bone metastases only); 2. Plan to receive at least 12 months continuous androgen deprivation therapy by a GnRH agonist; 3. Normal insulin sensitivity, assessed by co-investigators; 4. Able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study;
Exclusion criteria
1. Any acute condition or exacerbation of chronic conditions that in the investigators opinion would interfere with the trial visit schedule and procedures. 2. Concurrent chemotherapy or anti-androgen therapy; 3. Previous androgen deprivation therapy within last 12 months; 4. Hypothalamic or pituitary disorders, cancer other than prostate cancer, diabetes mellitus and chronic renal or hepatic illnesses; 5. Any medications known to interfere with the endocrine system (apart from ADT); 6. People in existing dependent or unequal relationships with any member of the research team; 7. People who may be involved in illegal activity; 8. People highly dependent on medical care; 9. Patients who had received an investigational new drug within the last 6 month; 10. Patients with a cognitive impairment, an intellectual disability or a mental condition which interfere with the patient's ability to understand the requirements of the study; 11. Inability to give written informed consent.
Outcome results
None listed