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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Exercise Intervention Protocol
  • SPoRT-Control Intervention

Treatment groups

60 Participants
are divided into 2 treatment groups