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NCT07680920Toborzás még nem indult

Effects of Combined Training in Prostate Cancer Patients

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 2.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
46 (tervezett)
Első benyújtás
2026. máj. 27.
Kezdés
2026. jún. 15.
Elsődleges befejezés
2027. máj.
Fő szponzor
Universidade Federal de Santa Catarina
Betegségek
Prosztatarák
NCT-szám
NCT07680920

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 46
  • 2026. jún. 15. és az elsődleges befejezés (2027. máj.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Más betegség

  • 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.

Kiket keres a vizsgálat

  • 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.

Életkor a regiszterben: 40 év – 75 év · Nem: csak férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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