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

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT05321953

Collaborator

American Physical Therapy Association (Other)

Enrollment

Location

Arms

12.2

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Constipation Constipation by Outlet Obstruction Constipation-predominant Irritable Bowel Syndrome Constipation - Functional	Other: Standard Physical Therapy Care Other: Aerobic and Inspiratory Muscle Training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 26, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

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

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 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 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Coral Gables	Florida	United States	33146

Sponsors and Collaborators

University of Miami
American Physical Therapy Association

Investigators

Principal Investigator: Lawrence Cahalin, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lawrence Cahalin, Professor of Clinical, University of Miami

ClinicalTrials.gov Identifier:

NCT05321953

Other Study ID Numbers:

20210958

First Posted:

Apr 11, 2022

Last Update Posted:

Jun 13, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Irritable Bowel Syndrome

Constipation

Study Results

No Results Posted as of Jun 13, 2022