Low to Moderate Load Power Training for Men With Metastatic Prostate Cancer.
ConditionProstatic Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorUniversity of Alicante
About this trial
The goal of this clinical trial is to learn if a low to moderate load power training program is feasible and effective for improving fitness and quality of life of people with prostate cancer under androgen suppression therapy and bone or lymph node metastasis. The main questions it aims to answer are:
* Does a low to moderate load power training program improve quality of life in people with metastatic prostate cancer under androgen deprivation therapy? * Does a low to moderate load power training program improve power, strength, endurance, and balance in people with metastatic prostate cancer under androgen deprivation therapy?
Researchers will compare the exercise program with routine care to see if power training works to improve common physical side effects of androgen suppression therapy in patients with metastatic prostate cancer.
Participants will:
* Participate in a supervised exercise program twice a week for 6 months or maintain routine care. * Perform fitness tests and questionnaires about quality of life and mental health. * Those who take part in the exercise program will also perform semi-structured in-depth interviews after the end of the program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histopathologically confirmed diagnosis of prostate adenocarcinoma.
Presence of metastases at initial diagnosis (synchronous mHSPC), or
Development of metastatic disease following prior treatment with curative intent (surgery and/or radiotherapy) (metachronous mHSPC).
Evidence of progression to castration-resistant prostate cancer (CRPC).
Disqualifiers
Evidence of visceral metastatic disease.
Current or prior treatment with a triplet regimen that includes chemotherapy.
History of pathological fracture.
Trial design
Design model
Parallel
Treatments tested in this trial
Power training group
Other interventionThe intervention consists of a supervised power-oriented resistance training program for older men with prostate cancer undergoing androgen deprivation therapy (ADT). Participants will complete 2 sessions per week over 24 weeks. Training focuses on improving muscle power through exercises performed at moderate intensity (40-50% 1RM), emphasizing a fast concentric phase and controlled eccentric phase. Multi-joint functional exercises targeting major muscle groups are included to enhance strength, balance, and daily functional performance. Training volume is low-to-moderate, and participants do not train to muscular failure, allowing maintenance of movement velocity and reducing fatigue. Adequate rest periods are provided between sets. The program is adapted to the clinical characteristics of the population, minimizing mechanical stress while promoting neuromuscular improvements. It is designed to be safe, feasible, and well-tolerated, with the aim of improving functional capacity.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Power training groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Health-related quality of life
Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. This instrument includes the Functional Assessment of Cancer Therapy-General (FACT-G) and a prostate cancer-specific subscale, providing a multidimensional assessment of physical, social/family, emotional, and functional well-being, as well as prostate cancer-related symptoms and concerns. The total score will be used for analysis, with higher scores indicating better quality of life. Results will be expressed in points, with a score range of 0 to 156. In addition, quality of life will be complemented by a final semi-structured interview exploring participants' perceptions and experiences after the intervention.
Time frame
From enrollment to the end of the exercise program at 6 months.Secondary outcomes
1
Rate of Force Development
A test will be conducted to calculate the rate of force development (RFD), defined as the ability of the neuromuscular system to increase contractile force in an optimal and rapid manner when activating a muscle from a low level or from rest. The assessment will be carried out using Chronojump strain gauges (Boscosystem, Spain) during a knee extension exercise at a 90-degree angle. Force (in Newtons) and time (in milliseconds) will be recorded continuously over a 200 ms time window and combined to report RFD in Newtons per second (N/s), calculated as ΔForce/ΔTime. Three 5-second trials will be performed with a one-minute rest between trials, and the mean of the three trials will be used as the single reported value for statistical analysis.
Time frame
From enrollment to the end of the exercise program at 6 months.2
Lower-body strength
Lower-body strength will be assessed using the Five Times Sit-to-Stand test. Participants will be instructed to stand up and sit down from a chair five times as quickly as possible, with arms crossed over the chest and without using the upper limbs for assistance. Performance will be recorded as the time required to complete the test, expressed in seconds (s).
Time frame
From enrollment to the end of the exercise program at 6 months.3
Handgrip strength
Maximal grip strength will be assessed using a dynamometer (Takei model 5101). Participants will perform two maximal trials with both the dominant and non-dominant hand following the recommendations of the American Society of Hand Therapists). Each contraction will be held for 3 seconds, with a 1-minute rest between trials. The highest value obtained from the two trials will be used for analysis. Results will be expressed in kilogram-force (kgf).
Time frame
From enrollment to the end of the exercise program at 6 months.4
Functional mobility
Functional mobility will be assessed using the Timed Up and Go (TUG) test. Participants will stand up from a chair, walk 3 meters, turn around, walk back, and sit down. One familiarization trial will be allowed before the recorded trial. Performance will be recorded as the time required to complete the test, expressed in seconds (s).
Time frame
From enrollment to the end of the exercise program at 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alicante
Lead sponsor
Hospital General Universitario Dr. Balmis de Alicante
Collaborator
Source ClinicalTrials.gov