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NCT04120025 Clinical Trial

Effectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients

GERD Clinical Trial

Official title:
Effectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04120025
Other study ID # 18-011131
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 24, 2019
Est. completion date September 15, 2022

Study information
Verified date January 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 192
Est. completion date September 15, 2022
Est. primary completion date September 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults with complaints of GERD, reflux, and/or heartburn symptoms Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Diaphragm Training
training on isolated abdominal breathing with proper effort and hold time to promote strengthening

Locations
Country Name City State
United States Mayo Clinic Jacksonville Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reflux Disease Questionnaire (RDQ) 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. Baseline, 1 month, 3 month, 6 month
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