Effectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients

Not Applicable

Completed

• Conditions: GERD
• Interventions: Behavioral: Diaphragm Training

• Registration Number: NCT04120025
• Lead Sponsor: Mayo Clinic

Brief Summary

Researchers are trying to determine if abdominal breathing exercises can reduce symptoms associated with GERD (Gastroesophageal reflux disease).

Detailed Description

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.

Study Timeline

• Study Start: 2019-09-24
• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• Adults with complaints of GERD, reflux, and/or heartburn symptoms

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Diaphragm Training	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

Primary Outcome Measures

Name	Time	Method
Reflux Disease Questionnaire (RDQ)	Baseline, 1 month, 3 month, 6 month	Change in self-reported reflux disease questionnaire using questions to assess subject symptoms. Subjects are asked to answer 12 questions based on their symptoms over the past seven days for frequency and severity.

Trial Locations

Locations (1)

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States