PRescription Exercise for Older Men With Urinary Disease

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06225479
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise — BEHAVIORAL
    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).
  • Calls and Newsletter — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jan 3, 2024
Status verified
Mar 2025
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control Arm
    Participants in this study arm will receive a remote health education program which consists of twice-monthly "Successful Aging" newsletters and phone calls to reinforce and discuss topics in each newsletter.
  • Experimental: Exercise Arm
    Participants in this study arm will receive an individualized 12-week exercise intervention plus a remote health education program.

Primary Outcome Measure

Feasibility: proportion randomized [ Time Frame: 18-24 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
San Francisco VA Medical CenterSan FranciscoCalifornia94121
Scott Bauer, MD
[email protected]
415-221-4810
UCSF Health - Mission Bay CampusSan FranciscoCalifornia94158
Natalie Rios
[email protected]
Jennette Sison
[email protected]
Stacey Kenfield (PRINCIPAL_INVESTIGATOR)
Scott Bauer (PRINCIPAL_INVESTIGATOR)

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