Effects of Combined Training in Prostate Cancer Patients

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Combined training
  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.

Первичные конечные точки

• Health-related quality of life assessed by the 36-item short form health survey (SF-36) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: From enrollment to the end of 12 weeks of physical exercise intervention.]

Вторичные конечные точки (10)

• Maximal aerobic capacity [Срок оценки: From enrollment to the end of 12 weeks of physical exercise intervention.]
• Lower limb functional strength [Срок оценки: From enrollment to the end of the 12-week physical exercise intervention.]
• Functional mobility [Срок оценки: From enrollment to the end of the 12-week physical exercise intervention.]
• Handgrip strength [Срок оценки: From enrollment to the end of the 12-week physical exercise intervention.]
• Systolic blood pressure [Срок оценки: Baseline and after 12 weeks of intervention.]
• Diastolic blood pressure [Срок оценки: Baseline and after 12 weeks of intervention.]
• Flow-mediated dilation [Срок оценки: Baseline and after 12 weeks of intervention.]
• Carotid intima-media thickness [Срок оценки: Baseline and after 12 weeks of intervention.]
• Heart rate variability [Срок оценки: Baseline and after 12 weeks of intervention.]
• 24-hour ambulatory blood pressure [Срок оценки: Baseline and after 12 weeks of intervention.]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07680920 · Proactive study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗