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

NCT ID: NCT05321953

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-26
• Study Completion Date: 2023-05-10

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.

Conditions

Constipation; Constipation by Outlet Obstruction; Constipation-predominant Irritable Bowel Syndrome; Constipation - Functional

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard Physical Therapy Care

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Standard Physical Therapy Care

Intervention Type: OTHER

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.

Aerobic and Inspiratory Muscle Training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Physical Therapy Association

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Lawrence Cahalin

Professor of Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lawrence Cahalin

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Coral Gables, Florida, United States

Countries

United States

Other Identifiers

20210958

Identifier Type: -

Identifier Source: org_study_id