Actively Recruiting
Led by Copenhagen University Hospital at Herlev · Updated on 2025-02-13
102
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the effects, safety, and feasibility of brief, high-impact exercise focused on bones in men with prostate cancer that has spread to the bones. This study aims to assess changes in bone health, body composition, physical function, quality of life, falls, hospitalizations, and the impact of resistance training on immune responses in blood and tumor tissue. The study is randomized and involves patients treated with hormone therapy for metastatic prostate cancer. Participants in the intervention group will engage in a 32-week exercise program at the hospital, with supervised sessions twice a week lasting about 30 minutes each. The first eight weeks involve low-impact and bodyweight exercises to gradually learn movement patterns and use weight training equipment safely. Resistance exercises like deadlifts, overhead presses, and squats are then performed at high intensity for the remaining weeks. Blood samples and tumor biopsies will be collected during the study to analyze immune responses. During the study, participants will undergo multiple assessments including lower body strength tests at baseline, 16, 32, and 44 weeks. Changes in body fat, muscle mass, bone mineral density, handgrip strength, fatigue, quality of life, physical activity, and safety events will be monitored throughout the study and for about one year. Hospitalizations, falls, and patient experiences will also be recorded. Immune responses will be specifically studied at several time points. This comprehensive monitoring helps understand how the exercise affects patients over time.
CONDITIONS
High Impact Training to Patients with Prostate Cancer and Bone Metastases
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 32 weeks
Participants assigned to the intervention group participate in a 32-week, twice-weekly, 30-minute supervised high impact training program at the hospital. The first 8 weeks focus on self-bodyweight and low-impact exercises to learn movement patterns and transition safely to high-intensity resistance exercises performed at 80% to 85% of 1 repetition maximum.
Twice-weekly supervised sessions
Duration - Approximately 12 weeks after treatment
Participants are monitored for safety, physical function, quality of life, and immune responses up to approximately 12 weeks after the intervention ends, including assessments up to 44 weeks and qualitative evaluations up to 6 months after study completion.
1 to 2 visits at weeks 44 and up to 6 months post-study
Total: 1 location
1
Herlev and Gentofte Hospital
Herlev, Herlev, Denmark, 2730
Actively Recruiting
A
Anne-Mette Ragle, PhD student
P
Peter Busch Østergren, MD, PhD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Anne-Mette Ragle, Marta Kramer Mikkelsen, Anders Vinther...
https://pubmed.ncbi.nlm.nih.gov/40722114