Effects of Breathing and Core Stabilization Exercises in Gastroesophageal Reflux Disease

November 4, 2026 updated by: Nurcan Contarli, Karabuk University

The Effects of Diaphragmatic Breathing Exercises and Core Stabilization Exercises on Symptom Severity, Quality of Life, and Sleep Quality in Patients With Gastroesophageal Reflux Disease

This study is a randomized controlled trial designed to investigate the effects of diaphragmatic breathing exercises and core stabilization exercises on symptom severity, quality of life, and sleep quality in patients with gastroesophageal reflux disease (GERD).

Participants will be randomly allocated into three groups: a control group, a diaphragmatic breathing exercise group, and a combined diaphragmatic breathing and core stabilization exercise group. The intervention program will last for 8 weeks. Diaphragmatic breathing exercises will be performed 5 days per week, while core stabilization exercises will be performed 3 days per week.

Posture, body awareness, pain intensity, GERD-related symptoms, quality of life, and sleep quality will be assessed using validated measurement tools. The aim of the study is to compare the therapeutic effects of these exercise interventions on GERD-related outcomes and overall patient well-being.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will be randomly assigned to three groups using a computer-assisted simple randomization method: (1) control group, (2) diaphragmatic breathing exercise group, and (3) combined diaphragmatic breathing and core stabilization exercise group. No exercise intervention will be applied to the control group. The exercise programs will last 8 weeks. Core stabilization exercises will be performed 3 days per week, while diaphragmatic breathing exercises will be performed 5 days per week.

Diaphragmatic breathing exercises will be designed to facilitate conscious activation of the diaphragm and to support the function of the lower esophageal sphincter and crural diaphragm. Core stabilization exercises will target the transversus abdominis, multifidus, pelvic floor, and diaphragm muscles, aiming to optimize trunk posture, abdominal-diaphragmatic coordination, and intra-abdominal pressure regulation.

Postural assessment will be performed using the Posture Screen Lite application. Body awareness will be evaluated with the Body Awareness Questionnaire. The location of musculoskeletal pain will be assessed using a body diagram, and pain intensity will be measured with the Visual Analog Scale (VAS). Disease-related symptom severity will be assessed using the Gastroesophageal Reflux Disease Questionnaire and the PROMIS GERD Scale. Quality of life will be evaluated using the Gastroesophageal Reflux Disease Quality of Life Questionnaire (GERD-QOL). Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 65 years.
  • Diagnosis of GERD by a gastroenterologist, and
  • Physical ability to participate in an exercise program.

Exclusion Criteria:

  • Presence of serious cardiopulmonary or neurological disorders,
  • History of abdominal, thoracic, or spinal surgery within the previous 6 months,
  • Presence of systemic conditions preventing participation in exercise, and
  • Participation in a regular exercise program during the study period.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control group

No exercise intervention will be applied to the control group.
Experimental: diaphragmatic breathing exercise group

Diaphragmatic breathing exercises will be performed 5 days per week.
Other: Diaphragmatic breathing exercise

Diaphragmatic breathing exercises will be designed to facilitate conscious activation of the diaphragm and to support the function of the lower esophageal sphincter and crural diaphragm.
Experimental: combined diaphragmatic breathing and core stabilization exercise group

The exercise programs will last 8 weeks. Core stabilization exercises will be performed 3 days per week, while diaphragmatic breathing exercises will be performed 5 days per week.
Other: Diaphragmatic breathing exercise

Diaphragmatic breathing exercises will be designed to facilitate conscious activation of the diaphragm and to support the function of the lower esophageal sphincter and crural diaphragm.

Other: Core stabilization exercise

Core stabilization exercises will target the transversus abdominis, multifidus, pelvic floor, and diaphragm muscles, aiming to optimize trunk posture, abdominal-diaphragmatic coordination, and intra-abdominal pressure regulation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Gastroesophageal Reflux Disease Questionnaire (GERD-Q)
Time Frame: 1 day

The Gastroesophageal Reflux Disease Questionnaire (GERD-Q) is a six-item Likert-type questionnaire that assesses the frequency of GERD-related symptoms over the past week. The first four items evaluate the frequency of typical symptoms and are used for the diagnosis of the disease and monitoring response to treatment. The remaining two items assess the frequency of the disease's impact on daily life, including over-the-counter medication use and sleep disturbance. Each item is scored on a four-point scale ranging from 0 to 3 according to symptom frequency. In items 1, 2, 5, and 6, higher scores indicate increased symptom frequency, whereas in items 3 and 4, scoring is reversed, with higher symptom frequency corresponding to lower scores.
1 day
The PROMIS GERD Scale
Time Frame: 1 day

The PROMIS GERD scale consists of 13 items. The questionnaire includes a total of 13 questions, each scored on a scale ranging from 0 to 4 points. The total score is obtained by summing the scores of all items.

According to the scoring system of the original questionnaire, a score of 0 indicates no symptoms, scores of 1-3 indicate minimal symptoms, scores of 4-7 indicate mild symptoms, scores of 8-15 indicate moderate symptoms, and scores of 16 and above indicate severe symptoms.
1 day
The Gastroesophageal Reflux Disease Quality of Life Questionnaire (GERD-QOL)
Time Frame: 1 day

The Gastroesophageal Reflux Disease Quality of Life Questionnaire (GERD-QOL) aims to assess how regurgitation and heartburn symptoms affect patients' daily life over the past 7 days. It consists of 16 items under four main domains: daily activities, treatment effect, diet, and psychological well-being. The questionnaire is rated using a five-point Likert scale. Lower total scores indicate poorer quality of life.
1 day
Postural analysis
Time Frame: 1 day

The Posture Screen Lite application is a posture analysis, body composition, and movement assessment software designed for use on iOS and Android devices with integrated camera systems. In this study, posture will be assessed using the iPad-based Posture Screen Lite application.

Participants will be assessed wearing appropriate clothing that leaves the upper trunk and lower legs exposed. Photographs will be taken from anterior, posterior, and right and left lateral views using a smartphone, without placing reference markers on the participant beforehand. The captured images will then be analyzed using the Posture Screen Lite software by identifying anatomical reference points on the photographs.

Based on these marked points, postural deviation values and the degree of postural imbalance will be calculated by the software and reported for each participant in centimeters (cm).
1 day
The Visual Analog Scale (VAS)
Time Frame: 1 day

The Visual Analog Scale (VAS) will be used to assess participants' pain intensity. The VAS is a valid and reliable method that is sensitive to small changes in clinical pain and treatment-related pain intensity.

Participants will be asked to indicate their pain level on a 10-cm horizontal line, where "0" represents "no pain" and "10" represents "the worst imaginable pain." In addition, participants will be asked to mark the location(s) of their pain on a body diagram to identify pain distribution and localization.
1 day
The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 1 day

The Pittsburgh Sleep Quality Index (PSQI) is a scale that evaluates sleep quality and sleep disturbances over a one-month period. The PSQI was developed by Buysse et al. (1989) and has been shown to have adequate internal consistency, test-retest reliability, and validity. The Turkish validity and reliability study was conducted by Ağargün et al. (1996), and the scale was found to be appropriate for the Turkish population. The Cronbach's alpha internal consistency coefficient is 0.80. The PSQI consists of 18 items used for scoring. It includes seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Some components are derived from a single item, while others are calculated by grouping multiple items. Each item is scored on a scale of 0 to 3, and the sum of the seven component scores yields the total PSQI score.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karabuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KBU-FTR-NC-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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