Clinical trial NCT05321953: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Constipation
Constipation by Outlet Obstruction
Constipation-predominant Irritable Bowel Syndrome
Constipation - Functional
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: American Physical Therapy Association
First posted: 2022-04-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change In Patient Assessment of Constipation Symptoms (PAC-SYM)
timeFrame: Baseline, 6 weeks, 14 weeks, 26 weeks
Secondary outcomes:
measure: Change In Distance by the Incremental Shuttle Walk Test (ISWT)
timeFrame: Week 6, week 14
measure: Change In estimated oxygen consumption (eVO2) by the Incremental Shuttle Walk Test (ISWT)
timeFrame: Week 6, week 14
measure: Change In Heart Rate Recovery (HRR)
timeFrame: Week 6, week 14
measure: Change In Maximal Inspiratory Pressure (PImax)
timeFrame: Week 6, week 14
measure: Change In Rand Short Form Health Survey Questionnaire (SF-36) scores
timeFrame: Week 6, week 14
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Lawrence Cahalin
role: PRINCIPAL_INVESTIGATOR
References: