The Impact of Aerobic Interval and Inspiratory Muscle Training On Patient Reported Outcome Scores… (NCT05321953) | Clinical Trial Compass
WithdrawnNot Applicable
The Impact of Aerobic Interval and Inspiratory Muscle Training On Patient Reported Outcome Scores In Individuals With Chronic Constipation
Stopped: Difficulty recruiting
United States0Started 2022-05-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Change In Patient Assessment of Constipation Symptoms (PAC-SYM)