← Back to Search

Behavioural Intervention

Respiratory Muscle Training + Education for Constipation

N/A

Recruiting

Led By Lawrence Cahalin, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults >18 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks, and 8 weeks

Awards & highlights

Study Summary

This trial tests if special exercises and education can improve constipation and patient satisfaction.

Who is the study for?

Adults over 18 with chronic constipation, who often strain or have hard stools, feel like they can't completely empty their bowels, need to help the process manually, or have fewer than three bowel movements a week. They must be able to follow the study plan and give informed consent. People with recent weight loss, medication conflicts, current pelvic floor physical therapy, cognitive issues, pregnancy, recent surgery without doctor's okay or severe rectal prolapse are excluded.Check my eligibility

What is being tested?

The trial is testing if a special breathing muscle training program combined with education on how to breathe while using the toilet can make patients more satisfied with their bowel movements compared to standard physical therapy care for those suffering from chronic constipation.See study design

What are the potential side effects?

Potential side effects may include discomfort from respiratory exercises and possible fatigue due to increased breathing effort during training sessions. However specific side effects related directly to this intervention are not detailed in the provided information.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks, and 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks, and 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change In Maximal Expiratory Pressure (PEmax)

Change In Maximal Inspiratory Pressure (PImax)

Change in Hospital Depression and Anxiety Scale (HADS)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hybrid Telehealth Inspiratory and Expiratory Muscle Training Program with Patient EducationExperimental Treatment1 Intervention

Participants will be instructed in performing a home respiratory muscle training program using a device called the Breather that trains both inspiratory and expiratory muscle strength for 8 weeks. They will also be provided patient education on proper breathing techniques to pass a bowel movement and optimal toilet posture.

Group II: Standard of Care Physical Therapy With No Study InterventionActive Control1 Intervention

Participants will receive 8 weeks of standard physical therapy care that includes interventions such as biofeedback treatment, manual therapy, therapeutic exercise, and education on improving bowel health.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Physical Therapy AssociationOTHER

15 Previous Clinical Trials

766 Total Patients Enrolled

1 Trials studying Constipation

University of MiamiLead Sponsor

901 Previous Clinical Trials

409,946 Total Patients Enrolled

1 Trials studying Constipation

Lawrence Cahalin, PhDPrincipal InvestigatorUniversity of Miami

1 Previous Clinical Trials

18 Total Patients Enrolled

Media Library

Hybrid Telehealth Program (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05823259 — N/A

Constipation Research Study Groups: Hybrid Telehealth Inspiratory and Expiratory Muscle Training Program with Patient Education, Standard of Care Physical Therapy With No Study Intervention

Constipation Clinical Trial 2023: Hybrid Telehealth Program Highlights & Side Effects. Trial Name: NCT05823259 — N/A

Hybrid Telehealth Program (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05823259 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for this experiment as of now?

"Clinicaltrials.gov reports that this particular medical study is no longer accepting candidates, as the initial posting came on June 1st 2023 and was last updated April 10th of 2023. Although not currently enrolling patients, there are 131 other clinical trials actively recruiting right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Impact of Respiratory Muscle Training and Patient Education on Chronic Constipation Outcomes

Lawrence Cahalin 2023. "The Impact of Respiratory Muscle Training and Patient Education on Chronic Constipation Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05823259.

All > Constipation