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

University of Miami

Status: Withdrawn

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

Treatments: Other: Aerobic and Inspiratory Muscle Training; Other: Standard Physical Therapy Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05321953

20210958

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard of Care Physical Therapy With No Study Intervention

Active Comparator group

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.

Treatment:

Other: Standard Physical Therapy Care

Standard of Care Physical Therapy With Study Intervention

Experimental group

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.

Treatment:

Other: Standard Physical Therapy Care

Other: Aerobic and Inspiratory Muscle Training