The Impact of Aerobic Interval and Inspiratory Muscle Training On Patient Reported Constipation Outcome Scores In Individuals With Chronic Constipation Who Plateau or Are Non- Responders to Biofeedback Therapy: A Call to Treat Beyond The Pelvic Floor
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change In Patient Assessment of Constipation Symptoms (PAC-SYM)
研究概览
简要总结
The primary aim of this study will be to determine if the addition of aerobic interval and inspiratory muscle training (IMT) targeted at improving cardiopulmonary-based measures will further improve patient satisfaction scores in individuals with chronic constipation (CC) who report plateau or limited improvements in CC after demonstrating a corrected defecation pattern using anorectal biofeedback training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults >18 years of age
- •Complaint of chronic constipation and associated symptoms
- •Confirmed pelvic floor muscle dyssynergia
- •Willing and able to sign informed consent
- •Ability to comply with study guidelines.
- •Potential subjects must report two or more of the following: straining during more than 25% of defecations, lumpy or hard stools more than 25% of defecations, sensations of incomplete bowel evacuation more than 25% of defecations, manual maneuvers to facilitate more than 25% of defecations, sensation of anorectal obstruction/blockage more than 25% of defecations, and fewer than 3 small bowel movements per week.
排除标准
- •Rectal prolapse greater than grade 2
- •Pregnancy
- •Cognitive impairments
- •History or present cardiac condition that would exclude them from moderate intensity exercise
- •Presence of an orthopedic condition with significant severity that the exercise protocol may exacerbate
- •Currently receiving additional physical therapy treatment for conditions associated with pelvic floor muscle dysfunction
- •Recent surgery within the past 3 months without clearance from a medical doctor
- •Medication usage that would interfere with their ability to exercise safely
- •Individuals recovering from a confirmed eating disorder or recent unexplained weight loss >10lbs within one month.
结局指标
主要结局
Change In Patient Assessment of Constipation Symptoms (PAC-SYM)
时间窗: Baseline, 6 weeks, 14 weeks, 26 weeks
The PAC-SYM questionnaire is a 12 item questionnaire that consists of three subscales: abdominal, rectal, and stool. Each item is scored 0-4 (0: Absent, 1: Mild, 2: Moderate, 3: Severe, 4: Very Severe). A total raw score can range from 0-48. The final score is the average of the summed score divided by the number of items, ranging from 0: Absent, 1: Mild, 2: Moderate, 3: Severe, 4: Very Severe.
次要结局
- Change In Heart Rate Recovery (HRR)(Week 6, week 14)
- Change In Rand Short Form Health Survey Questionnaire (SF-36) scores(Week 6, week 14)
- Change In Distance by the Incremental Shuttle Walk Test (ISWT)(Week 6, week 14)
- Change In estimated oxygen consumption (eVO2) by the Incremental Shuttle Walk Test (ISWT)(Week 6, week 14)
- Change In Maximal Inspiratory Pressure (PImax)(Week 6, week 14)
研究者
Lawrence Cahalin
Professor of Clinical
University of Miami