An interventional study of Combined training in Prostate Cancer Patients and Androgen Deprivation Therapy, sponsored by Universidade Federal de Santa Catarina. Not yet recruiting. Open to male participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Universidade Federal de Santa Catarina · Not applicable, Interventional, and Other
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.
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 and cardiovascular parameters 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 combined exercise program including muscle strength and aerobic capacity, 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 (maximal treadmill test, six-minute walk test, timed-up and go, 30-second sit-to-stand and handgrip strength), cardiovascular parameters (clinical 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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 46 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Universidade Federal de Santa Catarina is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
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Clinical diagnosis of prostate cancer stages I-III; Currently undergoing androgen deprivation therapy (ADT); Aged 40 to 75 years; No participation in research involving physical exercise or any systematic physical exercise intervention during the four months preceding the intervention; Residence in the Greater Florianópolis region, Santa Catarina, Brazil; Provision of written .
Exclusion Criteria:
Current participation in a structured physical exercise program; Presence of musculoskeletal disorders or other diseases that may prevent participation in the intervention or the assessment procedures.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A supervised, in-person physical exercise program will be implemented, lasting 12 weeks, with a frequency of three weekly sessions, held on non-consecutive days, lasting approximately 60 minutes per session. The first two weeks will be dedicated to familiarizing participants with the training protocol followed by 12 weeks of intervention. The program will be structured in progressive mesocycles, with three weeks for aerobic training and strength training. Each session will consist of three phases: (i) warm-up, with joint mobility exercises; (ii) main part, involving aerobic training and strength exercises; and (iii) cool-down, with stretching and relaxation exercises.
Other: Combined training
Participants will be instructed to continue with their usual activities.
The 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.
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.
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.
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.
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.
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.
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.
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.
Systolic blood pressure
Systolic blood pressure (SBP) will be measured using an OMRON automatic monitor (HEM-7113, Brazil). Unit of measure: mmhg
Time frame: Baseline and after 12 weeks of intervention.
Diastolic blood pressure
Diastolic blood pressure (DBP) will be measured using an OMRON automatic monitor (HEM-7113, Brazil). Unit of measure: mmhg
Time frame: Baseline and after 12 weeks of intervention.
Flow-mediated dilation
Vascular function will be assessed by flow-mediated dilation using a LOGIQ S7 expert ultrasound device (GE Healthcare). Unit of measure: %
Time frame: Baseline and after 12 weeks of intervention.
Carotid intima-media thickness
Carotid intima-media thickness will be assessed by B-mode ultrasound using a versana active device (GE Healthcare). Unit of measure: mm
Time frame: Baseline and after 12 weeks of intervention.
Heart rate variability
Cardiac autonomic modulation will be assessed through heart rate variability analysis. Unit of measure: (especificar o índice principal: RMSSD em ms, SDNN em ms, HF em ms² etc.).
Time frame: Baseline and after 12 weeks of intervention.
24-hour ambulatory blood pressure
Ambulatory blood pressure will be assessed over 24 hours using the dyna-MAPA device (Cardios). Unit of measure: mmhg
Time frame: Baseline and after 12 weeks of intervention.
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 intervention
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.
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.
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Jun 2026; primary completion for May 2027, 11 months later.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 11 months is below that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Universidade Federal de Santa Catarina