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

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Procedure: Exercise Intervention Protocol; Procedure: SPoRT-Control Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07064811

SPORT-MU

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

SPORT Protocol intervention

Experimental group

Description:

24 week velocity based resistance training. Twice weekly supervised sessions

Treatment:

Procedure: SPoRT-Control Intervention

SPORT Control intervention

Active Comparator group

Description:

24-week home based resistance training program .

Treatment:

Procedure: Exercise Intervention Protocol