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

Last updated: May 10, 2023
Sponsor: University of Miami
Overall Status: Trial Not Available

Phase

N/A

Condition

Constipation

Lactose Intolerance

Gastrointestinal Diseases And Disorders

Treatment

Aerobic and Inspiratory Muscle Training

Standard Physical Therapy Care

Clinical Study ID

NCT05321953
20210958
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 morethan 25% of defecations, lumpy or hard stools more than 25% of defecations, sensationsof incomplete bowel evacuation more than 25% of defecations, manual maneuvers tofacilitate more than 25% of defecations, sensation of anorectal obstruction/blockagemore than 25% of defecations, and fewer than 3 small bowel movements per week.

Exclusion

Exclusion Criteria:

  • Rectal prolapse greater than grade 2
  • Pregnancy
  • Cognitive impairments
  • History or present cardiac condition that would exclude them from moderate intensityexercise
  • Presence of an orthopedic condition with significant severity that the exerciseprotocol may exacerbate
  • Currently receiving additional physical therapy treatment for conditions associatedwith 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 weightloss >10lbs within one month.

Study Design

Treatment Group(s): 2
Primary Treatment: Aerobic and Inspiratory Muscle Training
Phase:
Study Start date:
May 26, 2022
Estimated Completion Date:
May 10, 2023

Connect with a study center

  • University of Miami

    Coral Gables, Florida 33146
    United States

    Site Not Available

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