Completed

Effectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients.

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What is being tested

Diaphragm Training

Behavioral
Who is being recruted

Deglutition Disorders+7

+ Digestive System Diseases

+ Esophageal Diseases

Over 18 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2019
See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 24, 2019

Actual date on which the first participant was enrolled.

Much like the pelvic floor controls urinary incontinence the "abdominal roof" made of the diaphragm appears to have the ability to control reflux. Other studies have had positive results but from extensive training of outpatients. Our population comes from ambulatory outpatients from family medicine at MCJ. After consent they fill out a reflux disease questionnaire (RDQ) a valid instrument for measuring symptoms of reflux. Subjects are educated on the basic concept of the study and then instructed in isolated diaphragm contraction breathing. once they are proficient they are asked to continue this program 3 x 10 repetitions, 3 times per day supplemented by 10 more repetitions after each meal to reduce post prandial symptoms. Follow up is done at 1, 3 and 6 months and includes reassessment via the RDQ and an assessment of estimated volume of exercise compliance.

Official TitleEffectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients.
NCT04120025
Principal SponsorMayo Clinic
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

192 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Deglutition DisordersDigestive System DiseasesEsophageal DiseasesGastroesophageal RefluxGastrointestinal DiseasesHeartburnSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsEsophageal Motility Disorders

Criteria

1 inclusion criteria required to participate
Adults with complaints of GERD, reflux, and/or heartburn symptoms
1 exclusion criteria prevent from participating
None

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjects will continue with usual care but will also receive diaphragm training (belly breathing) instructions using verbal, visual and tactile cues for proper contraction of the diaphragm as a home program

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Mayo Clinic Jacksonville

Jacksonville, United StatesOpen Mayo Clinic Jacksonville in Google Maps
CompletedOne Study Center