Effects of Combined Training in Prostate Cancer Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-75
SponsorUniversidade Federal de Santa Catarina
About this trial
Prostate cancer is the most prevalent type among men in Brazil, after non-melanoma skin cancer. One of the main treatment approaches is androgen suppression therapy (AST), which, although effective in controlling tumor growth, leads to several adverse effects such as erectile dysfunction, fatigue, reduced muscle mass, increased body fat percentage, decreased functional capacity and muscle strength, as well as a higher risk of cardiovascular events due to the sharp decline in testosterone and dihydrotestosterone. These factors significantly impair patients' quality of life. Physical exercise has been shown to mitigate such effects; however, in Brazil, only one study has so far evaluated the impact of exercise in men undergoing AST.
Given this context, the aim of the present study is to assess the effect of supervised physical exercise on quality of life, functional capacity, cardiovascular parameters, handgrip strength, and physical activity levels in men with prostate cancer undergoing AST. A randomized controlled clinical trial will be conducted, with patients allocated into an intervention group (IG) and a control group (CG). Data collection and the exercise intervention will take place at the Rehabilitation Center of the Sports Center at the Federal University of Santa Catarina (UFSC). The IG will participate in a supervised multicomponent exercise program including muscle strength, aerobic capacity, motor coordination, and flexibility, over 12 weeks, with 60-minute sessions three times per week.
Outcomes will be assessed before and after the intervention, covering quality of life (SF-36, EORTC QLQ-BR30, and EORTC QLQ-PR25 questionnaires), functional capacity (submaximal treadmill test, six-minute walk test, timed-up and go, 30-second sit-to-stand, and modified sit-and-reach), cardiovascular parameters (office and ambulatory systolic and diastolic blood pressure, resting heart rate, heart rate variability, flow-mediated dilation, arterial stiffness, and carotid intima-media thickness), body composition, and physical activity level. Adverse events will be recorded weekly. For statistical analysis, sample characterization variables will be examined using Student's t-test, Chi-square, and Fisher's exact test, while intervention outcomes will be analyzed using the generalized estimating equations (GEE) model, with significance set at p\<0.05, both by intention-to-treat and per-protocol approaches.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Combined training
Other interventionThe intervention will consist of a combined training protocol comprising aerobic and strength training. The aerobic training will be performed on a treadmill and the strength training on weight machines.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Combined training groupExperimental treatment 1 intervention
Group B: control sessionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Health-related quality of life assessed by the 36-item short form health survey (SF-36)
The 36-item short form health survey (SF-36) consists of 36 items distributed across eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Domain scores are transformed to a 0-100 scale, where 0 represents the worst health status and 100 represents the best health status. Higher scores indicate better health-related quality of life. Unit of measure: Score (0-100)
Time frame
From enrollment to the end of 12 weeks of physical exercise intervention.2
Health-related quality of life assessed by the european organisation for research and treatment of cancer quality of life questionnaire breast cancer module (EORTC QLQ-BR30)
The european organisation for research and treatment of cancer quality of life questionnaire breast cancer module (EORTC QLQ-BR30) consists of 30 items assessing functional domains and symptoms related to breast cancer. Scores are linearly transformed to a 0-100 scale. For functional scales and global health status/quality of life scales, higher scores indicate better functioning or quality of life. For symptom scales, higher scores indicate greater symptom burden. Unit of measure: Score (0-100)
Time frame
From enrollment to the end of 12 weeks of physical exercise intervention.3
Health-related quality of life assessed by the european organisation for research and treatment of cancer quality of life questionnaire prostate cancer module (EORTC QLQ-PR25)
The european organisation for research and treatment of cancer quality of life questionnaire prostate cancer module (EORTC QLQ-PR25) consists of 25 items assessing urinary, bowel, hormonal treatment-related, and sexual symptoms and functioning in patients with prostate cancer. Scores are linearly transformed to a 0-100 scale. For functional scales, higher scores indicate better functioning. For symptom scales, higher scores indicate greater symptom burden. Unit of measure: Score (0-100)
Time frame
From enrollment to the end of 12 weeks of physical exercise intervention.Secondary outcomes
1
Maximal aerobic capacity
Maximal aerobic capacity will be assessed using a maximal treadmill exercise test performed at a fixed speed with 1% incline increments until voluntary exhaustion. Peak oxygen uptake (VO₂peak) will be recorded in ml·kg-¹·min-¹.
Time frame
From enrollment to the end of 12 weeks of physical exercise intervention.2
Lower limb functional strength
Lower limb functional strength will be assessed using the 30-second sit-to-stand test. The outcome will be the number of completed sit-to-stand repetitions within 30 seconds.
Time frame
From enrollment to the end of the 12-week physical exercise intervention.3
Functional mobility
Functional mobility will be assessed using the timed up and go (TUG) test performed at habitual speed and maximum speed. The outcome will be the time required to complete the test, measured in seconds.
Time frame
From enrollment to the end of the 12-week physical exercise intervention.4
Handgrip strength
Handgrip strength will be assessed through maximal voluntary isometric contraction using a hand dynamometer. The outcome will be recorded in kilograms-force (kgf).
Time frame
From enrollment to the end of the 12-week physical exercise intervention.Other outcomes
1
Body composition
Body composition will be assessed using dual-energy X-ray absorptiometry (DXA). Outcomes will include total body fat percentage (%), fat mass (kg), lean mass (kg), and bone mineral density (g/cm²).
Time frame
From enrollment to the end of the 12-week physical exercise intervention2
Usual physical activity level
Usual physical activity level will be assessed using a triaxial accelerometer. Outcomes will include daily step count (steps/day), sedentary time (minutes/day), and time spent in moderate-to-vigorous physical activity (minutes/day).
Time frame
From enrollment to the end of the 12-week physical exercise intervention.3
Nutritional monitoring
Diet quality will be assessed using the questionnaire "How is your diet?". The outcome will be the total questionnaire score (points).
Time frame
From enrollment to the end of the 12-week physical exercise intervention.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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