The Impact of Aerobic Interval and Inspiratory Muscle Training On Patient Reported Outcome Scores In Individuals With Chronic Constipation
- Conditions
- Constipation-predominant Irritable Bowel SyndromeConstipation - FunctionalConstipationConstipation by Outlet Obstruction
- Interventions
- Other: Standard Physical Therapy CareOther: Aerobic and Inspiratory Muscle Training
- Registration Number
- NCT05321953
- Lead Sponsor
- University of Miami
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Physical Therapy With Study Intervention Aerobic and Inspiratory Muscle Training Participants who receive 6 weeks of standard physical therapy and have reported non satisfaction and respond with a numerical value of \>3 on a chronic constipation numeric scale and have been cleared of pelvic floor muscle dyssynergia. Participants will receive an additional 8 weeks of study intervention. Standard of Care Physical Therapy With No Study Intervention Standard Physical Therapy Care Participants will receive 6 weeks of standard physical therapy and have reported satisfaction and respond with a numerical value of ≤3 on a chronic constipation numeric scale. Participants will receive no additional study interventions. Standard of Care Physical Therapy With Study Intervention Standard Physical Therapy Care Participants who receive 6 weeks of standard physical therapy and have reported non satisfaction and respond with a numerical value of \>3 on a chronic constipation numeric scale and have been cleared of pelvic floor muscle dyssynergia. Participants will receive an additional 8 weeks of study intervention.
- Primary Outcome Measures
Name Time Method Change In Patient Assessment of Constipation Symptoms (PAC-SYM) 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.
- Secondary Outcome Measures
Name Time Method Change In Heart Rate Recovery (HRR) Week 6, week 14 Heart rate recovery (HRR) will be measured as the difference of the peak heart rate at the end of the first exercise session and one minute post exercise. This will be recorded through the Polar Heart Rate chest monitor.
Change In Rand Short Form Health Survey Questionnaire (SF-36) scores Week 6, week 14 The SF-36 is a widely recognized outcome measure used to measure health status in a variety of populations. The measure consists of eight domains and each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Lower scores measure more disability and higher scores measure less disability. Scores represent the percentage of the total possible score achieved. Items in the same domain are averaged together to create 8 scale scores.
Change In Distance by the Incremental Shuttle Walk Test (ISWT) Week 6, week 14 The Incremental Shuttle Walk Test (ISWT) is an incremental externally paced walking test and is generally used as an index of cardiorespiratory fitness. The primary outcome is the distance covered calculated from the completed number of shuttles. The ISWT distance can be used to track changes in exercise capacity over time.
Change In estimated oxygen consumption (eVO2) by the Incremental Shuttle Walk Test (ISWT) Week 6, week 14 The Incremental Shuttle Walk Test (ISWT) is an incremental externally paced walking test and is generally used as an index of cardiorespiratory fitness. Peak estimated oxygen consumption (eVO2) can be estimated with greater accuracy than other field tests using a linear prediction equation incorporating ISWT distance.
Change In Maximal Inspiratory Pressure (PImax) Week 6, week 14 PImax will be measured via the test of incremental respiratory endurance (TIRE) using the Pro2fit device and application.
Trial Locations
- Locations (1)
University of Miami
🇺🇸Coral Gables, Florida, United States