The Impact of Aerobic Interval and Inspiratory Muscle Training On Patient Reported Outcome Scores In Individuals With Chronic Constipation

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Constipation; Constipation-predominant Irritable Bowel Syndrome; Constipation - Functional; Constipation by Outlet Obstruction
• Intervention / Treatment: Other: Standard Physical Therapy Care; Other: Aerobic and Inspiratory Muscle Training

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care Physical Therapy With No Study Intervention; 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.	Other: Standard Physical Therapy Care; Standard physical therapy care. Six to eight, one hour sessions over the course of 4-6 weeks. For individuals with chronic constipation that includes biofeedback therapy, breathing techniques on the toilet, manual therapy to the abdominal wall, and education on toileting posture and favorable lifestyle habits for gut health.
Experimental: Standard of Care Physical Therapy With Study Intervention; 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.	Other: Standard Physical Therapy Care; Standard physical therapy care. Six to eight, one hour sessions over the course of 4-6 weeks. For individuals with chronic constipation that includes biofeedback therapy, breathing techniques on the toilet, manual therapy to the abdominal wall, and education on toileting posture and favorable lifestyle habits for gut health.; Other: Aerobic and Inspiratory Muscle Training; The exercise-based 3 times per week for 8 weeks intervention will consist of aerobic interval training and inspiratory muscle training (IMT) for a total duration of 30 minutes. Aerobic-based intervals will be performed at a moderate intensity. Aerobic modes of exercise will include upper extremity ergometer, treadmill, bike, or elliptical.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change In Patient Assessment of Constipation Symptoms (PAC-SYM)	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.	Baseline, 6 weeks, 14 weeks, 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change In Distance by the Incremental Shuttle Walk Test (ISWT)	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.	Week 6, week 14
Change In estimated oxygen consumption (eVO2) by the Incremental Shuttle Walk Test (ISWT)	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.	Week 6, week 14
Change In Heart Rate Recovery (HRR)	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.	Week 6, week 14
Change In Maximal Inspiratory Pressure (PImax)	PImax will be measured via the test of incremental respiratory endurance (TIRE) using the Pro2fit device and application.	Week 6, week 14
Change In Rand Short Form Health Survey Questionnaire (SF-36) scores	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.	Week 6, week 14

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: American Physical Therapy Association
• Investigators: Principal Investigator: Lawrence Cahalin, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Constipation
• Other Study ID Numbers: 20210958

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No