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

Primary Purpose

Constipation, Constipation by Outlet Obstruction, Constipation-predominant Irritable Bowel Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Physical Therapy Care
Aerobic and Inspiratory Muscle Training
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care Physical Therapy With No Study Intervention

Standard of Care Physical Therapy With Study Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Change In Maximal Inspiratory Pressure (PImax)
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
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.

Full Information

First Posted
April 1, 2022
Last Updated
May 10, 2023
Sponsor
University of Miami
Collaborators
American Physical Therapy Association
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1. Study Identification

Unique Protocol Identification Number
NCT05321953
Brief Title
The Impact of Aerobic Interval and Inspiratory Muscle Training On Patient Reported Outcome Scores In Individuals With Chronic Constipation
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty recruiting
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
May 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
American Physical Therapy Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Constipation by Outlet Obstruction, Constipation-predominant Irritable Bowel Syndrome, Constipation - Functional

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Physical Therapy With No Study Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard of Care Physical Therapy With Study Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Physical Therapy Care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic and Inspiratory Muscle Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change In Patient Assessment of Constipation Symptoms (PAC-SYM)
Description
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.
Time Frame
Baseline, 6 weeks, 14 weeks, 26 weeks
Secondary Outcome Measure Information:
Title
Change In Distance by the Incremental Shuttle Walk Test (ISWT)
Description
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.
Time Frame
Week 6, week 14
Title
Change In estimated oxygen consumption (eVO2) by the Incremental Shuttle Walk Test (ISWT)
Description
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.
Time Frame
Week 6, week 14
Title
Change In Heart Rate Recovery (HRR)
Description
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.
Time Frame
Week 6, week 14
Title
Change In Maximal Inspiratory Pressure (PImax)
Description
PImax will be measured via the test of incremental respiratory endurance (TIRE) using the Pro2fit device and application.
Time Frame
Week 6, week 14
Title
Change In Rand Short Form Health Survey Questionnaire (SF-36) scores
Description
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.
Time Frame
Week 6, week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Cahalin
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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