Breathing Exercises in Patients With Gastroesophageal Reflux

NCT06812650 | Completed

• 1 other identifier: KBU-FTR-2024/1814
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to examine the effects of diaphragmatic breathing exercises combined with relaxation exercises on patient-reported reflux symptoms, quality of life, anxiety, and depression levels in patients diagnosed with gastroesophageal reflux.

Conditions

Reflux Disease, Gastro-Esophageal

Keywords

Breathing Exercises; Relaxation; Quality of Life; Anxiety

Outcome Measures

Primary Outcomes (2)

• Gastroesophageal Reflux Disease Questionnaire

  Reflux symptoms will be assessed with the Gastroesophageal Reflux Disease Questionnaire. The frequency of 6 questions regarding heartburn, regurgitation, dyspepsia, nausea, need for medication, and sleep disturbances in the last 7 days are scored. The total score can range from 0-18.

  Eight weeks

• Gastroesophageal Reflux Disease- Quality of Life

  The scale aims to measure how regurgitation and pyrosis symptoms have affected the patient's daily life in the last 7 days. It consists of 16 questions under 4 main headings: daily activity, treatment effect, diet and psychological well-being. It is evaluated with a five-point Likert-type scale. A low total score indicates that the quality of life has also decreased.

  Eight weeks

Secondary Outcomes (1)

• The Hospital Anxiety and Depression Scale

  Eight weeks

Study Arms (2)

Medical Treatment

ACTIVE COMPARATOR

Other: Medical treatment

Exercise

EXPERIMENTAL

The exercise program will consist of diaphragmatic breathing exercises and progressive muscle relaxation exercises.

Other: Medical treatment; Other: Exercise

Interventions

Medical treatment OTHER

Patients will continue their routine medical treatment for gastroesophageal reflux disease.

Exercise; Medical Treatment

Exercise OTHER

The exercise program will consist of diaphragmatic breathing exercises and progressive muscle relaxation exercises. Diaphragmatic breathing exercises will be performed for 8 weeks, 5 days a week, twice a day, for 15 minutes each time.

Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who do not have cardiopulmonary, mental, connective tissue, metabolic, or other diseases that may prevent exercise
• Individuals who do not have body mass index \>35 or \<18
• Individuals who are not addicted to alcohol or cigarettes
• Individuals who are between the ages of 18 and 65
• Individuals who are diagnosed with non-erosive reflux will be included in the study.

You may not qualify if:

• Individuals with a history of gastrointestinal surgery
• Individuals who are pregnant or breastfeeding
• Individuals who have hiatal hernia

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Private Maras Health Services

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Anxiety Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

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: Professor

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: February 3, 2025
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)