Standardized Resistance Training Program and Assessment System for Prostate Cancer Patients Receiving Androgen Deprivation Therapy ISPoRT-PCa-ADT Study Protocol for a Randomized Controlled Trial. SPORT-MU

Обзор

This randomized controlled trial (RCT) with two parallel study arms evaluated the effectiveness of a 24-week exercise intervention in prostate cancer (PCa) patients under-going androgen deprivation therapy (ADT). Ethical approval was obtained from the Clinical Research Ethics Committee of the University Clinical Hospital "Virgen de la Arrixaca" (Murcia, Spain). Participants were randomly assigned to one of two groups: (1) a supervised progressive resistance training program (SPoRT-PCa-ADT), or (2) a control group receiving a home-based exercise protocol following an initial assessment, accom-panied by weekly telephone follow-up. Assessments were conducted at baseline and at 24 weeks to examine changes in physical, functional, and psychosocial outcomes. Addi-tionally, patient-reported outcomes were collected at the 12-week midpoint (Figure 1). This study design enabled the evaluation of both immediate and sustained intervention effects and facilitated a direct comparison between supervised and home-based exercise approaches

Подробное описание

This randomized controlled trial (RCT) with two parallel study arms evaluated the effectiveness of a 24-week exercise intervention in prostate cancer (PCa) patients under-going androgen deprivation therapy (ADT). Ethical approval was obtained from the Clinical Research Ethics Committee of the University Clinical Hospital "Virgen de la Arrixaca" (Murcia, Spain). Participants were randomly assigned to one of two groups: (1) a supervised progressive resistance training program (SPoRT-PCa-ADT), or (2) a control group receiving a home-based exercise protocol following an initial assessment, accom-panied by weekly telephone follow-up. Assessments were conducted at baseline and at 24 weeks to examine changes in physical, functional, and psychosocial outcomes. Addi-tionally, patient-reported outcomes were collected at the 12-week midpoint (Figure 1). This study design enabled the evaluation of both immediate and sustained intervention effects and facilitated a direct comparison between supervised and home-based exercise approaches

Вмешательства

• Процедура Exercise Intervention Protocol
  Subjects participated in the supervised exercise program twice weekly (with a 48-72-hour interval between sessions) for 24 weeks, totaling 48 supervised sessions. The progressive resistance training program used velocity-based training principles \[24-26\], a novel approach in exercise oncology that allows for precise load management and indi-vidualization based on daily performance capacity
• Процедура SPoRT-Control Intervention
  structured written instructions for a personalized home-based resistance training program. The protocol was designed to prioritize safety, progressive adaptation, and individualization based on each participant's functional capacity and available resources at home. The program was intended to be performed two to three times per week on non-consecutive days, focusing exclusively on lower-body training through a single primary movement. Each session consisted of three effective sets of 12 repetiti

Первичные конечные точки

• Progressive loading test [Срок оценки: Up for a 24 weeks]
• Vertical jump test [Срок оценки: up for 24 weeks]
• Maximum Isometric Contraction Test [Срок оценки: up for 24 weeks]
• Fatigue assessment [Срок оценки: Up for 24 weeks]
• Quality of Life Assessment [Срок оценки: Up for a 24 weeks]
• Psychological Distress [Срок оценки: Up for 24 weeks]
• Urinary Function [Срок оценки: Up for a 24 weeks]
• Sleep Quality [Срок оценки: Up for a 24 weeks]

Критерии участия

Критерии включения

• diagnosis of locally advanced or metastatic prostate neoplasm and current treatment with androgen deprivation therapy (ADT)
• treatment at the radiotherapy oncology department of University Clinical Hospital "Virgen de la Arrixaca"
• legal adult age with signed informed consent

Критерии исключения

• unwillingness to participate in the study
• inability to complete adequate follow-up due to any cause that would prevent knowledge of patient evolution during the follow-up period
• no controlled or symptomatic metastatic bone disease
• physical disabilities that would prevent participants from safely completing the exercise protocol

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

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• HCUVA — Murcia

Публикации

• Soler-Lopez A, Gomez-Carmona CD, Gonzalez-Devesa D, Lopez-Plaza D, Herrero-Vidal L, Toledo-Pozuelo R, Gonzalez-Costea A, Cao-Avellaneda E. Standardized Program of Resistance Training for Prostate Cancer Patients Receiving Androgen Deprivation Therapy (SPoRT-PCa-ADT): study protocol for a randomized controlled trial. BMC Cancer. 2026 Apr 22;26(1):711. doi: 10.1186/s12885-026-15902-w. PMID 42015017

Идентификаторы

NCT: NCT07064811 · SPORT-MU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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