NCT04120025

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

October 7, 2019

Last Update Submit

January 18, 2023

Conditions

GERD

Keywords

RefluxHeartburn

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control Group

NO INTERVENTION

Subject will continue standard of care for GERD symptoms

Treatment Group

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

Behavioral: Diaphragm Training

Interventions

Diaphragm TrainingBEHAVIORAL

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

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

Gastroesophageal RefluxHeartburn

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher J Yelvington, DPT

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2019

First Posted

October 9, 2019

Study Start

September 24, 2019

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

January 19, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)