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

NCT05321953 | Withdrawn

• 1 other identifier: 20210958
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change In Patient Assessment of Constipation Symptoms (PAC-SYM)

  The PAC-SYM questionnaire is a 12 item questionnaire that consists of three subscales: abdominal, rectal, and stool. Each item is scored 0-4 (0: Absent, 1: Mild, 2: Moderate, 3: Severe, 4: Very Severe). A total raw score can range from 0-48. The final score is the average of the summed score divided by the number of items, ranging from 0: Absent, 1: Mild, 2: Moderate, 3: Severe, 4: Very Severe.

  Baseline, 6 weeks, 14 weeks, 26 weeks

Secondary Outcomes (5)

• Change In Distance by the Incremental Shuttle Walk Test (ISWT)

  Week 6, week 14

• Change In estimated oxygen consumption (eVO2) by the Incremental Shuttle Walk Test (ISWT)

  Week 6, week 14

• Change In Heart Rate Recovery (HRR)

  Week 6, week 14

• Change In Maximal Inspiratory Pressure (PImax)

  Week 6, week 14

• Change In Rand Short Form Health Survey Questionnaire (SF-36) scores

  Week 6, week 14

Study Arms (2)

Standard of Care Physical Therapy With No Study Intervention

ACTIVE COMPARATOR

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.

Other: Standard Physical Therapy Care

Standard of Care Physical Therapy With Study Intervention

EXPERIMENTAL

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.

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

Interventions

Standard Physical Therapy Care OTHER

Standard physical therapy care. Six to eight, one hour sessions over the course of 4-6 weeks. For individuals with chronic constipation that includes biofeedback therapy, breathing techniques on the toilet, manual therapy to the abdominal wall, and education on toileting posture and favorable lifestyle habits for gut health.

Standard of Care Physical Therapy With No Study Intervention; Standard of Care Physical Therapy With Study Intervention

Aerobic and Inspiratory Muscle Training OTHER

The exercise-based 3 times per week for 8 weeks intervention will consist of aerobic interval training and inspiratory muscle training (IMT) for a total duration of 30 minutes. Aerobic-based intervals will be performed at a moderate intensity. Aerobic modes of exercise will include upper extremity ergometer, treadmill, bike, or elliptical.

Standard of Care Physical Therapy With Study Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• American Physical Therapy Association: collaborator

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lawrence Cahalin

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 11, 2022
• Study Start: May 26, 2022
• Primary Completion: May 10, 2023
• Study Completion: May 10, 2023
• Last Updated: May 12, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)