Effectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients

NCT ID: NCT04120025

Last Updated: 2023-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-24

Study Completion Date

2022-09-15

Brief Summary

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

Detailed Description

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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.

Conditions

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GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Subject will continue standard of care for GERD symptoms

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment Group

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

Group Type EXPERIMENTAL

Diaphragm Training

Intervention Type BEHAVIORAL

training on isolated abdominal breathing with proper effort and hold time to promote strengthening

Interventions

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Diaphragm Training

training on isolated abdominal breathing with proper effort and hold time to promote strengthening

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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C. Joseph Yelvington P.T., D.P.T.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher J Yelvington, DPT

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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18-011131

Identifier Type: -

Identifier Source: org_study_id

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