PRescription Exercise for Older Men With Urinary Disease (PROUD) Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Acceptability: proportion satisfied with exercise intervention
研究概览
简要总结
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.
详细描述
This study will provide valuable insights into the feasibility of an individualized, remotely-monitored, and home-based exercise intervention as well as the effect of this intervention on lower urinary tract symptom (LUTS) severity and mechanistic measures (physical function, lower urinary tract function, frailty-related mechanistic biomarkers) in a diverse group of older men with LUTS attributed to benign prostatic hyperplasia (BPH). The potential public health benefit to society in this study could be large, as the investigators are targeting a common condition in older men (one in three older men develop LUTS in their lifetime).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
This will be a 2-arm, partially-blinded, attention-controlled RCT. The randomization scheme will be computer-generated by the study statistician without participant contact. Participants will be randomized 1:1 in randomly permuted block sizes (2 or 4) to the exercise intervention or health education control arm stratified by recruitment site and any BPH medication use (yes/no). The randomization scheme is uploaded to University of California San Francisco (UCSF) REDCap and the study coordinator will randomize participants in UCSF REDCap. Assessors (for urinary and physical function testing), data analysts, and investigators will remain blinded to participants' randomization arm.
Primary outcomes will be collected using self-administered questionnaires without risk of unblinding. Intervention status and any variables related to intervention status will be recorded and stored in a separate database by unblinded Clinical Research Coordinator (CRC).
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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).
- •History of recurrent bladder or prostate infections (3 or more infections in the previous 12 months before screening).
- •History of severe or end-stage chronic kidney disease disease, kidney transplant, heart transplant, congenital heart disease, severe heart failure (defined as current New York Heart Association (NYHA) Class III or IV), valvular heart disease, diabetic coma, or the presence of a pacemaker or implantable cardiac defibrillator without clinician clearance.
- •Heart attack or myocardial infarction, heart surgery, cardiac catheterization, stroke, transient ischemic attack, brain hemorrhage, bleeding brain aneurysm, blood clot in leg or lungs, symptomatic hypoglycemia or hyperglycemia, hip fracture, or non-elective hospitalization <6 months before screening. If conditions occurred 6 to <12 months before screening, can participate with clinician clearance.
- •Bladder or prostate infection <1 months before screening. If infection occurred between 1 to <3 months before screening, can participate with clinician clearance.
- •Major surgery <3 months before screening or scheduled in the subsequent 7 months.
- •Terminal illness diagnosis with estimated life expectancy <12 months.
- •Plan to leave the study area for >28 consecutive days during the subsequent 7 months.
- •Participation in formal behavioral LUTS interventions (e.g., pelvic floor physiotherapy) <1 month before screening.
- •Symptoms of possible coronary artery disease, heart failure, arrythmia, stroke, carotid artery stenosis, valvular heart disease, blood clot in lungs, poorly controlled diabetes, peripheral vascular disease, or bladder or prostate infection without clinician clearance.
- •Maximum urinary flow rate <=4 ml/sec OR volume voided during free flow <120ml during screening or the baseline visit.
- •Post-void residual >=450ml measured by ultrasound during screening or the baseline visit.
- •Uncontrolled hypertension (systolic blood pressure >180mmHg or diastolic blood pressure >110mmHg) or hypotension (systolic blood pressure<100mmHg) measured during baseline visit anthropometric assessments.
- •Severe abnormalities on standard clinical labs measured prior to the baseline visit, without clinician clearance, including hemoglobin A1c (>10%) and urinary albumin: creatinine ratio (>300 mg/g).
- •Other medical, psychiatric, or behavioral factors or participation in other research studies that, based on the judgment of the multiple principal investigators, may interfere with study participation, assessments, or the ability to follow either the exercise intervention or the health education control.
- •Use of a permanent or temporary urinary catheter.
研究组 & 干预措施
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.
干预措施: Calls and Newsletter (Other)
Exercise Arm
Participants in this study arm will receive an individualized 12-week exercise intervention plus a remote health education program.
干预措施: Exercise (Behavioral)
结局指标
主要结局
Acceptability: proportion satisfied with exercise intervention
时间窗: 3 months
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
Safety: number of adverse events
时间窗: 3 months
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.
Change in maximum urinary flow rate
时间窗: 3 months
Change in maximum urinary flow rate (Q max) from weeks 0 to 12, measured by trained clinical urology staff using a uroflowmeter in mL per second
Feasibility: proportion randomized
时间窗: 18-24 months
Proportion of participants randomized of those screened (completed screening call)
Fidelity: proportion completing at least 70% of exercise sessions
时间窗: 3 months
Proportion of intervention arm non-drop-outs completing at least 70% of exercise sessions over 12 weeks
Change in International Prostate Symptom Score
时间窗: 3 months
Change in International Prostate Symptom Score (IPSS) from weeks 0 to 12, collected via digital surveys prior to week 0 (baseline) and 12-week visits. Range: 0 (minimum - better) to 35 (maximum - worse)
次要结局
- Fidelity: number of exercise sessions completed for aerobic, resistance, and balance/flexibility exercise(3 months)
- Acceptability: proportion who would recommend exercise intervention(3 months)