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Prostate Cancer PatientsProactiveNCT07680920

Effects of Combined Training in Prostate Cancer Patients

A study testing Combined training in people with Prostate Cancer Patients and Androgen Deprivation Therapy, run by Universidade Federal de Santa Catarina.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 years, men only
What is being tested?
Combined training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
No sites listed yet
Study dates
15 Jun 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Effect of Combined Training on Quality of Life, Functional Capacity, Cardiovascular Function, and Body Composition in Prostate Cancer Patients Undergoing Androgen Suppression Therapy: a Randomized Controlled Clinical 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.

Read the detailed description

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.

Being tested
Combined training
Keywords
prostate cancer, androgen suppression therapy, Physical exercise, combined exercise
Medical subject headings
Prostatic Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined trainingOther

    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.

Study groups in NCT07680920
Study groupRoleWhat they receive
Combined training groupExperimentalA 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.
Receives: Other: Combined training
control sessionNo interventionParticipants will be instructed to continue with their usual activities.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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)

    Measured: 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)

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

Secondary outcomes (10)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

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

  5. Systolic blood pressure

    Systolic blood pressure (SBP) will be measured using an OMRON automatic monitor (HEM-7113, Brazil).

    Unit of measure: mmhg

    Measured: Baseline and after 12 weeks of intervention.

  6. Diastolic blood pressure

    Diastolic blood pressure (DBP) will be measured using an OMRON automatic monitor (HEM-7113, Brazil).

    Unit of measure: mmhg

    Measured: Baseline and after 12 weeks of intervention.

  7. Flow-mediated dilation

    Vascular function will be assessed by flow-mediated dilation using a LOGIQ S7 expert ultrasound device (GE Healthcare).

    Unit of measure: %

    Measured: Baseline and after 12 weeks of intervention.

  8. 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

    Measured: Baseline and after 12 weeks of intervention.

  9. 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.).

    Measured: Baseline and after 12 weeks of intervention.

  10. 24-hour ambulatory blood pressure

    Ambulatory blood pressure will be assessed over 24 hours using the dyna-MAPA device (Cardios).

    Unit of measure: mmhg

    Measured: Baseline and after 12 weeks of intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2026
  2. Study start15 Jun 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07680920
Sponsor's protocol ID
Proactive study
Acronym
Proactive
Status last verified
Jun 2026
First submitted
27 May 2026
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Combined training in people with Prostate Cancer Patients and Androgen Deprivation Therapy, run by Universidade Federal de Santa Catarina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related quality of life assessed by the 36-item short form health survey (SF-36) (time frame: From enrollment to the end of 12 weeks of physical exercise intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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