← 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

Must not have

Recent surgery within the past 3 months without clearance from a medical doctor

Recent unexplained weight loss >10lbs within one month.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks, and 8 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I had surgery in the last 3 months and haven't been cleared by a doctor.

Select...

I have lost more than 10 pounds in the last month without trying.

Select...

I am undergoing physical therapy for pelvic floor muscle issues.

Select...

My rectal prolapse is severe.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change In Maximal Expiratory Pressure (PEmax)

Change In Maximal Inspiratory Pressure (PImax)

Change in Hospital Depression and Anxiety Scale (HADS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

A historical control group of participants who received about 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 / 5Eligibility criteria met