The Effect of a Structured Strength and Endurance Training Program on Quality of Life, Fitness, Blood Parameters and Survival in Prostate Cancer Patients
NCT ID: NCT07126860
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
150 participants
INTERVENTIONAL
2024-05-24
2027-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Physical Training and Cancer-a Multicenter Clinical Trial
NCT02473003
CHAMP: A Randomized Controlled Trial of High-intensity Aerobic and Resistance Exercise for Metastatic Prostate Cancer
NCT02613273
Community-Based Exercise and Nutrition Training and Education Program for Cancer Survivors
NCT06565260
Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer
NCT03672396
Protein-rich Nutritional Therapy Combined With Time-efficient Exercise in Cancer Therapy
NCT04065815
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
150 men will be recruited with either localized, locally advanced, or metastatic PC. Patients will be randomly assigned in a 2:1 ratio to either the intervention arm (guided home-based training) or the standard of care (SOC) arm (self-directed or no exercise). Prior to enrollment, participants will provide written informed consent, undergo clinical eligibility confirmation, and complete screening assessments. Owing to the already documented general health benefits of exercise in patients with PC, participants randomized to the SOC arm will be informed about the benefits of exercise as well, and will be motivated to engage in exercise under their own management (self-directed exercise). Changes in physical activity will be monitored in both groups.
This study will include a screening phase, a 12-week intervention phase, a post-12-week intervention phase, and a longer-term intervention phase.
During the screening phase (maximally 35 days prior to the first training session), participants will undergo assessments to determine their eligibility for the study. This involves evaluating inclusion and exclusion criteria, as well as data collection on demographics and tumor stage. To avoid bias and to ensure equal participation and motivation of participants from both the intervention and the SOC arm in the baseline tests, patient randomization will only take place after the baseline testing.
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 radical prostatectomy (RP) or completion of external-beam radiotherapy (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. The control arm will receive SOC without any exercise prescriptions. Throughout the phase, participants' physical activity will be monitored using regular questionnaires and wearable device data. Efficacy evaluations will be conducted at baseline and after the 12-week intervention phase.
The post-12-week intervention phase will follow the 12-week intervention phase and will last for 1 year. Throughout this phase, QoL, oncological outcomes, laboratory parameters, as well as ongoing physical activity will be assessed periodically.
The longer-term intervention phase will begin 1 year after completion of the 12-week intervention phase, and will continue until one of the following events occurs: death, loss to follow-up or withdrawal of consent, or end of the study, whichever occurs first. Throughout this phase, oncological outcomes will be assessed periodically.
The study population will consist of men diagnosed with localized, locally advanced, or metastatic PC. Participants with localized or locally advanced PC may be enrolled pre- or post- RP, or at any point before, during, or after EBRT. Training will then commence 4-8 weeks after completion of RP or EBRT. Participants with locally advanced, non-metastatic, and metastatic PC under systemic treatment and not undergoing local curatively intended treatment can be enrolled at any time under any treatment.
All measurements will be assessed at baseline (maximally 14 days prior to the first training session) and after the 12-week intervention phase. Additionally, laboratory parameters, patient-reported outcome (PRO) assessments, and wearable data assessments will be repeated 3, 6, and 12 months after completion of the 12-week intervention phase.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Structured 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.
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
The control arm will receive SOC, as well as a booklet with general information and guidelines about physical activity in prostate cancer patients, but without any specific exercise prescriptions.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Participant has to be ≥ 18 years of age
3. Participant must have either localized, locally advanced, or metastatic PC which has been treated or is planned to be treated either by RP, EBRT, androgen deprivation therapy (ADT), androgen receptor signaling inhibitor (ARSI), or any combination
4. Participant must understand and remember the training regimen
5. Participant must have a smartphone to connect a wearable device
6. Participant must have a smartphone or computer to access the online platform
7. Participant has to be able to speak, understand, and read German or English
8. Participant must sign an informed consent form (ICF)
Exclusion Criteria
2. High risk of pathological fracture due to unstable bone metastases (note: patients with bone metastasis are generally eligible for participation in the study and program as long as there is no acute high risk of fracture)
3. Any condition for which it may not be in the best interest of the patient to participate in the study
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Shimon Kempin
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sabine Brookman-May, Professor, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Ludwig-Maximilians - University of Munich
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ludwig Maximilian University Hospital Campus Großhadern
Munich, Bavaria, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23-0573
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.