PRescription Exercise for Older Men With Urinary Disease (PROUD) Pilot Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 60
Healthy Volunteers: f
View:

• Age 60 years or older.

• Male sex at birth.

• Moderate-to-severe LUTS over the past month (defined as International Prostate Symptom Score \[IPSS\] \>=12).

• A clinical diagnosis of LUTS/BPH as demonstrated by a current or prior BPH medication prescription (alpha-blocker, 5alpha-reductase inhibitor, daily phosphodiesterase type 5 inhibitor) OR untreated LUTS/BPH and a maximum urinary flow rate \<=12 ml/sec.

• Physically inactive as defined in the Molecular Transducers of Physical Activity Consortium (MoTrPAC): no more than 1 day per week, lasting no more than 60 minutes, of regular endurance/aerobic exercise \[e.g., brisk walking, jogging, running, cycling, elliptical, or swimming activity that results in feelings of increased heart rate (HR), rapid breathing, and/or sweating\] or resistance exercise \[resulting in muscular fatigue\] in the past year). Leisure walkers are eligible unless they meet the HR, breathing, and sweating criteria.

• Able to walk 400m without sitting, leaning, or the help of another person (observed during exercise testing) to ensure safety while exercising with remote monitoring. Use of a straight cane is allowed.

• Able to speak and complete questionnaires in English.

• Have an iOS or Android smartphone capable of installing the Polar Beat app.

Locations
United States
California
San Francisco VA Medical Center
RECRUITING
San Francisco
UCSF Health - Mission Bay Campus
RECRUITING
San Francisco
Contact Information
Primary
Scott R. Bauer, MD, ScM
Scott.Bauer@ucsf.edu
415-221-4810
Backup
Stacey Kenfield, ScD
Stacey.Kenfield@ucsf.edu
415.476.5392
Time Frame
Start Date: 2024-01-03
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 68
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, San Diego, University of California, Berkeley
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov