Resistance Training for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Toronto

Must be taking: Androgen deprivation therapy

Disqualifiers: Other cancer, Recent fall, Gait aid, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Prostate cancer and its treatment are associated with many long-term adverse effects including cancer-related cognitive impairment. Specifically, androgen deprivation therapy has been shown to negatively impact cognitive function. Combined aerobic and resistance training has been shown to improve cognitive function in men treated with androgen deprivation therapy, but limited research has observed its impact into survivorship. Additionally, existing study designs are limited to supervised, combined aerobic and resistance training interventions. Remotely-delivered resistance training programs could enhance exercise participation by overcoming commonly reported barriers in men living with and beyond prostate cancer such as transportation, distance to facility, and timing of programs. Alongside the needs to address cancer-related cognitive impairments due to androgen deprivation therapy, resistance training may serve to manage functional deficits, losses in bone mineral density and muscle mass and increases in cardiometabolic risk factors. This study will assess the feasibility of an 8-week remotely-delivered resistance training program to improve cognitive function in men living with and beyond prostate cancer who have a history of androgen deprivation therapy treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Remotely-Delivered Resistance Training Program for prostate cancer?

Research shows that resistance training can improve muscle strength, cardiovascular health, and quality of life in prostate cancer patients, even when delivered remotely. Studies have also found that exercise can help counteract the side effects of prostate cancer treatments like hormone therapy. ^{1 2 3 4 5}

Is resistance training safe for prostate cancer patients?

Resistance training is generally safe for prostate cancer patients, with studies showing improvements in physical function and no serious adverse events reported during supervised programs. ^{5 6 7 8 9}

How is the Remotely-Delivered Resistance Training Program different from other treatments for prostate cancer?

This treatment is unique because it is delivered remotely, allowing patients to participate in resistance training from home, which can improve muscle strength and quality of life. Unlike traditional treatments that may require in-person visits, this approach offers greater accessibility and convenience for prostate cancer patients. ^{4 7 10 11 12}

Eligibility Criteria

This trial is for men who have or had prostate cancer and were treated with androgen deprivation therapy. It's designed to see if working out at home with resistance training can help improve their thinking skills, which may be affected by their treatment.

Inclusion Criteria

Not physically active (self-report <90 minutes of MVPA/week and <2 days of RT/week)

I am not currently receiving radiation therapy.

I have prostate cancer with minimal or no symptoms and have been treated with hormone therapy.

Exclusion Criteria

I have another type of cancer besides the one being treated.

Have experienced a fall in the last 12 months

Current participation in other exercise programs/trials

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week remotely-delivered resistance training program to improve cognitive function

8 weeks

16 sessions (8 live, 8 pre-recorded)

Follow-up

Participants are monitored for changes in cognitive function, physical function, and self-reported exercise and fatigue

4 weeks

Treatment Details

Interventions

• Remotely-Delivered Resistance Training Program

Trial Overview The study tests an 8-week program where participants do resistance exercises at home. The goal is to find out if this type of exercise can help manage cognitive issues that sometimes happen after prostate cancer treatments.

Participant Groups

Group I: Resistance Training Experimental Treatment 1 Intervention

The resistance training intervention will consist of two remotely-delivered exercise sessions per week for eight weeks (16 sessions total). One session will be a live, remotely delivered 1:1 class led by a qualified exercise professional (\~one hour). The second session will be unsupervised, completed by watching a pre-recorded workout video that will vary bi-weekly to elicit progressive overload. Pre-recorded workout videos will be emailed and feature the qualified exercise professional who will provide instruction to mimic live sessions. Both sessions will involve a dynamic warm-up (\~10 minutes), 8 resistance-band exercises (\~30-45 minutes), followed by a cool-down (\~10 minutes).

Group II: Usual Care Active Control 1 Intervention

The usual care group will receive exercise guidelines for cancer survivors (i.e., educational material) from the American College of Sport Medicine. Exercise guidelines materials will be provided through email.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Findings from Research

A 10-month study involving 40 prostate cancer patients showed that a home-based progressive resistance exercise training program significantly improved aerobic capacity, upper and lower limb strength, and health-related quality of life compared to a control group that received usual care.

While the exercise program did not significantly affect brachial artery flow-mediated dilatation, it was deemed safe, with only five adverse events reported, indicating that it can be a beneficial addition to recovery after robot-assisted radical prostatectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial. Ashton, RE., Aning, JJ., Tew, GA., et al.[2021]

This phase III randomized controlled trial involves 866 participants with metastatic castrate-resistant prostate cancer (mCRPC) to assess whether supervised high-intensity aerobic and resistance exercise can improve overall survival compared to self-directed exercise.

The study will also explore the relationship between exercise and various health factors, such as immune function and metabolic biomarkers, which may help understand how exercise impacts survival outcomes in mCRPC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. Newton, RU., Kenfield, SA., Hart, NH., et al.[2022]

This study will compare the effectiveness of a telehealth-delivered exercise and nutrition program against a traditional clinic-based program in 104 overweight/obese men with prostate cancer, focusing on reducing fat mass while preserving muscle mass.

The trial aims to demonstrate that a remote intervention can be as effective as in-person supervision, making it more accessible for patients undergoing androgen deprivation therapy, which often leads to increased fat mass.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss for overweight and obese patients with prostate cancer: a study protocol of a randomised trial comparing clinic-based versus Telehealth delivered EXercise and nutrition intervention (the TelEX trial). Galvão, DA., Taaffe, DR., Hayne, D., et al.[2022]

A supervised exercise program combining endurance and resistance training significantly improved various health markers in 27 prostate cancer patients undergoing androgen-deprivation therapy, including muscular endurance and cardiorespiratory fitness.

Participants also experienced improvements in quality of life, as evidenced by better performance in the six-minute walk test and reduced depression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. Caty, G., Salazar Gajardo, S., Butoescu, V., et al.[2019]

A systematic review of 21 trials involving 1748 prostate cancer patients found that resistance exercise significantly improved body composition, functional capacity, and muscle strength, with a notable reduction in fat mass and an increase in lean mass.

The study suggests that lower volume resistance training at moderate to high intensity is just as effective as higher volume training, which may help make exercise more accessible and encourage adherence among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. Lopez, P., Taaffe, DR., Newton, RU., et al.[2023]

A pilot randomized controlled trial involving 25 men with metastatic castrate-resistant prostate cancer (mCRPC) demonstrated that remotely monitored exercise training is feasible, safe, and acceptable, with 82% of participants completing the 12-week program.

Participants showed high adherence to the exercise regimen, completing 90% of aerobic and 96% of resistance training sessions, and reported high satisfaction with the program, indicating strong potential for future studies on exercise's impact on clinical outcomes in this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and acceptability of a remotely monitored exercise pilot CHAMP: A Clinical trial of High-intensity Aerobic and resistance exercise for Metastatic castrate-resistant Prostate cancer. Kenfield, SA., Van Blarigan, EL., Panchal, N., et al.[2022]

A supervised exercise training intervention integrated into standard prostate cancer care was feasible and well-accepted, with 79% of eligible participants (36 out of 45) receiving the intervention despite COVID-19 lockdowns.

Participants engaged in an average of 27 minutes of aerobic exercise per session, achieving 92% of their target heart rate, and completed the program without serious adverse events, indicating the safety and potential benefits of exercise in managing the side effects of androgen deprivation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial). Reale, S., Turner, RR., Sutton, E., et al.[2021]

In a study of 83 prostate cancer patients undergoing 6 months of resistance exercise, high compliance (88.5%) was linked to greater improvements in trunk fat mass and appendicular lean mass, indicating that sticking to the exercise regimen can enhance body composition outcomes.

Despite varying levels of compliance, significant improvements in physical function and muscle strength were observed across the board, suggesting that resistance exercise is beneficial for all participants, even those with lower attendance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting Attendance and Resistance Exercise Compliance in Men with Localized Prostate Cancer. Lopez, P., Taaffe, DR., Newton, RU., et al.[2023]

This study aims to evaluate the safety and efficacy of a 3-month modular multi-modal exercise program for 90 prostate cancer survivors with bone metastases, addressing concerns about muscle atrophy and functional impairments due to prior treatments.

The exercise program is designed to be safe for patients with bone metastases, potentially improving physical function and delaying skeletal complications, which could significantly enhance the quality of life for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial. Galvão, DA., Taaffe, DR., Cormie, P., et al.[2022]

In a study of 72 prostate cancer patients undergoing radiation therapy, both high-intensity interval training (HIIT) and resistance training (RES) significantly reduced cancer-treatment-related fatigue compared to usual care, indicating their efficacy in managing side effects of treatment.

Both exercise modalities were found to be safe, with no adverse events reported, and they improved functional exercise capacity, demonstrating that structured exercise can be beneficial during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training compared with resistance training in prostate cancer patients undergoing radiotherapy: a randomized controlled trial. Piraux, E., Caty, G., Renard, L., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparing eccentric resistance exercise in prostate cancer survivors on and off hormone therapy: a pilot study. [2015]

2. Germany pubmed.ncbi.nlm.nih.gov

Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Weight loss for overweight and obese patients with prostate cancer: a study protocol of a randomised trial comparing clinic-based versus Telehealth delivered EXercise and nutrition intervention (the TelEX trial). [2022]

5. Belgium pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and acceptability of a remotely monitored exercise pilot CHAMP: A Clinical trial of High-intensity Aerobic and resistance exercise for Metastatic castrate-resistant Prostate cancer. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Embedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial). [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Reporting Attendance and Resistance Exercise Compliance in Men with Localized Prostate Cancer. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Effects of resistance training frequency on physical functioning and quality of life in prostate cancer survivors: a pilot randomized controlled trial. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training compared with resistance training in prostate cancer patients undergoing radiotherapy: a randomized controlled trial. [2021]