The Impact of a Widely Accessible Respiratory Muscle Training Program Integrated with Patient Education Utilizing a Hybrid Telehealth Platform on Patient-Reported Constipation Outcome Scores: a Call to Treat Beyond the Pelvic Floor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 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 a respiratory muscle training program that includes both inspiratory muscle training (IMT) and expiratory muscle training (EMT), targeted at improving respiratory muscle performance-based measures combined with patient education about breathing on the toilet will improve patient satisfaction scores in individuals with chronic constipation (CC).
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
- 是
入选标准
- •Adults >18 years of age
- •Complaint of CC and associated symptoms
- •Willing and able to sign an informed consent
- •The ability to comply with study guidelines
- •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
- •Currently receiving 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
- •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, 4 weeks, and 8 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). 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. A total raw score can range for 0-48, however the average score is used to indicate the level of constipation from 0-4 with a higher number indicating higher severity of constipation.
次要结局
- Change In Maximal Expiratory Pressure (PEmax)(Baseline and 8 weeks)
- Change In Maximal Inspiratory Pressure (PImax)(Baseline and 8 weeks)
- Change in Hospital Depression and Anxiety Scale (HADS)(Baseline and 8 weeks)
研究者
Lawrence Cahalin
Professor of Clinical
University of Miami