PRescription Exercise for Older Men With Urinary Disease (NCT06225479) | Clinical Trial Compass
RecruitingNot Applicable
PRescription Exercise for Older Men With Urinary Disease
United States68 participantsStarted 2024-01-03
Plain-language 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.
Who can participate
Age range60 Years
SexMALE
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Inclusion criteria
✓. 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.
. 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.
✕. History of overactive bladder procedure (e.g., intravesical Botox, sacral neuromodulation, posterior tibial nerve stimulation).
✕. History of prostate cancer (treated with surgery or radiation), bladder cancer, other lower urinary tract cancer, pelvic radiation, or active non-urologic cancer treatments.
✕. History of urethral strictures.
✕. History of neurogenic bladder or neurologic conditions causing lower urinary tract dysfunction (e.g., Parkinson's disease, multiple sclerosis, other progressive neurological disease).