Status:

WITHDRAWN

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

Lead Sponsor:

University of Miami

Collaborating Sponsors:

American Physical Therapy Association

Conditions:

Constipation

Constipation by Outlet Obstruction

Eligibility:

All Genders

18+ years

Phase:

NA

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 p...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 26 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 10 2023

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT05321953

Start Date

May 26 2022

End Date

May 10 2023

Last Update

May 12 2023

Active Locations (1)

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1

University of Miami

Coral Gables, Florida, United States, 33146