PRescription Exercise for Older Men With Urinary Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age60+
SponsorUniversity of California, San Francisco
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Prescribed overactive bladder medications (e.g., anti-muscarinics, beta-3-adrenergic agonists) <3 months before screening.
Initiation, dose escalation, or weaning of BPH medications <1 month before screening (<6 months for 5-alpha-reductase inhibitors). Participants' must also be willing to not start, stop, or change their BPH medications for the subsequent 7 months (the entire study period).
Initiation, dose escalation, or weaning of other pharmacologic agents or dietary supplements that might affect LUTS (e.g., saw palmetto, testosterone, diuretics, glucose-lowering agents) <1 month before screening. Participants' must also be willing to not start, stop, or change these medications for the subsequent 7 months (the entire study period) unless deemed necessary by their clinician.
History of BPH procedure or surgery.
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
BehavioralAn 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 interventionA 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.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Control ArmActive comparator 1 intervention
Group B: Exercise ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility: proportion randomized
Proportion of participants randomized of those screened (completed screening call)
Time frame
18-24 months2
Acceptability: proportion satisfied with exercise intervention
Proportion of participants who report being satisfied or very satisfied with the exercise intervention at 12 weeks, assessed via digital survey prior to the week 12 visit
Time frame
3 months3
Fidelity: proportion completing at least 70% of exercise sessions
Proportion of intervention arm non-drop-outs completing at least 70% of exercise sessions over 12 weeks
Time frame
3 months4
Safety: number of adverse events
Number of adverse events, serious adverse events, and unexpected problems (as defined in the Data and Safety Monitoring Plan) by study. Adverse event severity will be defined by the Common Terminology Criteria for Adverse Events (CTCAE) and whether "attributable" to the exercise intervention.
Time frame
3 monthsSecondary outcomes
1
Acceptability: proportion who would recommend exercise intervention
Proportion of intervention arm participants who would recommend the exercise intervention to others at 12 weeks, assessed via digital survey prior to the week 12 visit
Time frame
3 months2
Fidelity: number of exercise sessions completed for aerobic, resistance, and balance/flexibility exercise
Number of exercise sessions completed over 12 weeks, recorded by the exercise coach based on participant exercise session records. The coach will also report the number of aerobic and resistance exercise sessions completed as prescribed or with greater duration or intensity (e.g., higher heart rate for aerobic sessions or greater sets, reps, and/or weight for resistance sessions) over 12 weeks, based on coaching calls.
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
University of California, Berkeley
Collaborator
University of California, San Diego
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov