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PRescription Exercise for Older Men With Urinary Disease

NCT06225479 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-03-17

No results posted yet for this study

Summary

This is a single-center pilot randomized controlled trial among 68 physically "inactive" older men with lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (LUTS/BPH) assessing a 12-week remote exercise intervention versus health education control.

Conditions

  • Lower Urinary Tract Symptoms
  • Benign Prostatic Hyperplasia

Interventions

BEHAVIORAL

Exercise

An individualized 12-week exercise intervention that will follow American College of Sports Medicine guidelines to ensure a gradual safe increase in frequency and intensity. The exercise goals for participants in the intervention arm are to increase minutes/week of aerobic exercise, build strength and muscle mass, and improve flexibility, core strength, and balance progressively over the course of 12 weeks. The participants are prescribed 3 sessions of aerobic exercise lasting 45-75 minutes each, including warm up and cool down; 2 resistance training sessions per week, and at least 3 flexibility and balance sessions per week. Intervention arm receives the following: Control arm "Successful Aging" newsletter plus additional educational materials related to exercise, heart rate monitor and resistance bands, and two 90-minute sessions and ten 30-minute phone sessions over 12 weeks with an exercise coach (the first two sessions include a resistance training session).

OTHER

Calls and Newsletter

A 12-week remote health education program developed by the study team to provide a control for the exercise intervention. Participants in this arm will receive a summary of the American College of Sports Medicine guidelines (self-directed and time-based), a twice-monthly "Successful Aging" newsletter with suggestions for health diet, stress reduction, and social engagement, and twice-monthly phone calls to reinforce and discuss topics in the newsletter and to review adverse events and change in medications.

Sponsors & Collaborators

Principal Investigators

  • Scott R. Bauer, MD, ScM · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-03
Primary Completion
2026-04-01
Completion
2026-04-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06225479 on ClinicalTrials.gov