Structured strength and endurance training for men with prostate cancer
ZMoveMent-1: Effect of a Resistance and Aerobic Training Intervention on Quality of Life, Fitness, Immunological Parameters, and Oncological Outcome in Patients With Prostate Cancer
This program will test whether a guided home-based combination of resistance and aerobic exercise can improve quality of life, fitness, blood markers, and survival for men treated for localized or metastatic prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Ludwig-Maximilians - University of Munich Academic / other |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT07126860 on ClinicalTrials.gov |
What this trial studies
This two-arm, open-label randomized trial will enroll 150 men with localized, locally advanced, or metastatic prostate cancer and randomize them 2:1 to a guided home-based combined resistance and aerobic training program or to standard of care with self-directed exercise. Participants will complete screening assessments, a 12-week intervention phase, and longer-term follow-up with repeated measures of quality of life, body composition, fitness, immunological and blood parameters, and oncological outcomes. Physical activity will be monitored using wearable devices linked to an online platform and participants will require a smartphone or computer for connectivity. The trial excludes patients with contraindicating cardiovascular, neurological, or musculoskeletal conditions and those with unstable bone metastases at high fracture risk.
Who should consider this trial
Good fit: Men aged 18 or older with histologically confirmed prostate adenocarcinoma (localized, locally advanced, or metastatic) who can understand the regimen, use a smartphone or computer, and safely perform resistance and aerobic exercise are ideal candidates.
Not a fit: Patients with contraindications to exercise such as unstable bone metastases with high fracture risk or serious cardiovascular, neurological, or musculoskeletal comorbidities may not benefit and are excluded.
Why it matters
Potential benefit: If successful, the program could help men with prostate cancer reduce fatigue, gain strength, improve cardiovascular health and quality of life, and possibly influence cancer-related outcomes.
How similar studies have performed: Previous trials and observational studies have shown that strength and aerobic exercise improve physical and mental well-being, body composition, and cardiovascular health in men with prostate cancer, though effects on survival and oncological outcomes remain uncertain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant must have a histologically diagnosed adenocarcinoma of the prostate 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: 1. Cardiovascular/neurological/musculoskeletal comorbidities with contraindications for resistance or aerobic training 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
Where this trial is running
Munich, Bavaria
- Ludwig Maximilian University Hospital Campus Großhadern — Munich, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Sabine Brookman-May, Professor, Dr. med. — Ludwig-Maximilians - University of Munich
- Study coordinator: Benazir Enzinger, Dr. med.
- Email: Benazir.Enzinger@med.uni-muenchen.de
- Phone: +49 176 83497017
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.