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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Constipation
- Sponsor
- University of Miami
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Change In Patient Assessment of Constipation Symptoms (PAC-SYM)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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).
Investigators
Lawrence Cahalin
Professor of Clinical
University of Miami
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change In Patient Assessment of Constipation Symptoms (PAC-SYM)
Time Frame: 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.
Secondary Outcomes
- 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)