Effects of Combined Training in Prostate Cancer Patients

NCT07680920 | Not Yet Recruiting DMC

• 1 other identifier: Proactive study
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prostate Cancer Patients; Androgen Deprivation Therapy

Keywords

prostate cancer; androgen suppression therapy; Physical exercise; combined exercise

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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)

  From enrollment to the end of 12 weeks of physical exercise intervention.

Secondary Outcomes (10)

• Maximal aerobic capacity

  From enrollment to the end of 12 weeks of physical exercise intervention.

• Lower limb functional strength

  From enrollment to the end of the 12-week physical exercise intervention.

• Functional mobility

  From enrollment to the end of the 12-week physical exercise intervention.

• Handgrip strength

  From enrollment to the end of the 12-week physical exercise intervention.

• Systolic blood pressure

  Baseline and after 12 weeks of intervention.

Other Outcomes (3)

• Body composition

  From enrollment to the end of the 12-week physical exercise intervention

• Usual physical activity level

  From enrollment to the end of the 12-week physical exercise intervention.

• Nutritional monitoring

  From enrollment to the end of the 12-week physical exercise intervention.

Study Arms (2)

Combined training group

EXPERIMENTAL

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

control session

NO INTERVENTION

Participants will be instructed to continue with their usual activities.

Interventions

Combined training OTHER

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.

Combined training group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: Only males with prostate cancer in ADT
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Santa Catarina: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This study is a two-arm, single-center, 1:1 superiority-allocation randomized controlled clinical trial conducted in parallel with assessors blinded to the groups. If blinding the assessors is not possible, the data analyses will be blinded. Participants will be randomized into an intervention group (IG) and a control group (CG). The IG will undergo combined training, while the CG will continue with their usual activities. After the research is completed, both groups will be invited to participate free of charge in extension projects with physical exercise for cancer patients at the Sports Center (CDS) of the Federal University of Santa Catarina (UFSC). This study will be designed following the CONSORT (Consolidated Standards of Reporting Trials) recommendations. It was submitted to the Ethics Committee of UFSC and was approved.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: July 2, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share