The Effect of a Structured Strength and Endurance Training Program on Quality of Life, Fitness, Blood Parameters and Survival in Prostate Cancer Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Structured combined resistance and aerobic training: The 12-week intervention phase comprises the initial 12 weeks of a home-based combined resistance and aerobic training protocol for the intervention arm. Training will commence 8 weeks (when medically cleared, a reduction to minimally 4 weeks is possible) after RP or completion of EBRT, or any time for PC patients undergoing systemic treatment. As part of their visit for baseline testing, participants will be familiarized with the online platform incorporating the training program, including the correct execution of the exercises. In addition, the online platform includes demonstration videos of all exercises. Detailed information about the training program will be available for patients and investigators via a website and smartphone application. Additionally, participants will receive a printed document explaining the training program, the repetitions in reserve (RIR) scale (Helms et al., 2016), and the online tool/app for tracking.

Standard of Care: Participants randomized to the SOC arm will also be informed about the benefits of exercise and motivated to engage in exercise under their own management (self-directed exercise). They will receive a booklet with general information and guidelines about physical activity in prostate cancer patients, but without any specific exercise prescriptions.

Study summary

Prostate cancer is the second most common cancer among men. Many patients experience a significantly reduced quality of life due to either the cancer itself or the side effects of treatment. These side effects can include tiredness, weight gain, loss of muscle and strength, bone weakness, depression, reduced sexual function, and increased risk of heart problems. A commonly used treatment called androgen deprivation therapy, which reduces the levels of male hormones, can make these symptoms worse.

Previous research has shown that physical exercise-both strength training and endurance training-can help improve physical and mental well-being in men with prostate cancer. Regular exercise has also been shown to improve body composition, cardiovascular health, and reduce cancer-related fatigue. Some studies even suggest that exercise might support the immune system and slow down the progression of cancer.

The aim of this clinical trial is to find out whether a specific combination of resistance and aerobic training can help improve quality of life and health outcomes in men with prostate cancer. The exercise program is designed to be performed at home using simple equipment like resistance bands and bodyweight exercises, along with high-intensity interval training for endurance. Participants are asked to train three to six days a week.

150 men with prostate cancer at various stages of the disease will be included. These men will be randomly divided into two groups: two-thirds will receive the exercise program (intervention group), and one-third will continue with their usual care without the program (control group). The initial training period lasts 12 weeks and will be repeated to ensure that all participants in the exercise group train for at least six months. After that, they will be encouraged to keep training on their own.

The main goal of the study is to see if the exercise program leads to improvements in quality of life, physical fitness, body composition, and markers of immune function. It will also be analyzed how well the participants stick to the program, whether a longer training period has more benefits, how physically active the participants are overall, and how the program might affect other health and cancer-related outcomes.

The underlying hypothesis is that a structured, home-based resistance and aerobic training program will improve quality of life, physical fitness, body composition, immune function, and possibly cancer-related outcomes in men with prostate cancer.

Eligibility

Primary outcome measure(s)

• Change from Baseline in the Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Score — Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
  Range of 0-156 points. Higher points mean higher QoL.
• Change from Baseline in Total Muscle Thickness (TMT) — Baseline and after 12-week intervention phase
  Muscle Thickness (MT) will be measured via ultrasound (linear head held perpendicular to the skin) at 4 sites (anterior and posterior upper arm, anterior and lateral thigh). For the primary outcome, the sum of those 4 sites will be used (TMT), but the separate results will also be reported. The measurement protocol used is adapted from Schoenfeld et al. (2019): https://doi.org/10.1249/MSS.0000000000001764
• Change from Baseline in Serum Low-Density Lipoprotein (LDL) in milligrams/deciliter (mg/dl) — Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase

Trial sites (1)

More Ludwig-Maximilians - University of Munich trials in Germany

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