NCT07064811

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	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
PROCEDURE	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 repetitions, which served as the standard training volume for the main exercise.

Timeline

• Start date: 2025-11-15
• Primary completion: 2027-02-15
• Completion: 2027-02-15
• First posted: 2025-07-15
• Last updated: 2025-07-15

Locations

1 site across 1 country: Spain