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Completed

NCT Number: NCT06812650

Breathing Exercises in Patients With Gastroesophageal Reflux

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private Maras Health Services

Istanbul, Turkey (Türkiye)

About this study

Gastroesophageal reflux disease is a pathological condition in which various symptoms and/or complications occur as a result of the escape of stomach contents into the esophagus, oral cavity, or lungs. Gastroesophageal reflux disease is largely associated with various respiratory diseases such as chronic cough, idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease, and asthma. Accordingly, respiratory function deterioration may be observed in spirometric measurements. Increased symptom burden in gastroesophageal reflux patients has been associated with poor quality of life, sleep disturbances, and decreased physical function and productivity. However, increased anxiety and depression levels in patients are also closely related to reflux symptoms.At the esophagogastric junction, the lower esophageal sphincter and the surrounding crura of the diaphragm constitute an important part of the protective mechanism against reflux. The crural diaphragm, which contracts during inspiration, acts as an additional external sphincter. Since the crural diaphragm is a striated muscle structure, it is possible to improve its function with exercise. Eherer et al. (2012) examined the effects of diaphragmatic breathing exercises performed for 30 minutes per day for 4 weeks on pH levels, quality of life, and medication use in patients with non-erosive reflux. As a result of the study, they found that quality of life increased and acid exposure decreased.The recurrence rate and maintenance treatment requirement after treatment are high in reflux patients. Proton pump inhibitor drugs commonly used in treatment may have various side effects in the long term. Although the diaphragm muscle is an important part of the protective mechanism against reflux, there are few studies investigating the effects of applications targeting this muscle on reflux.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Medical treatment

Other

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

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.

Primary outcomes

  1. Gastroesophageal Reflux Disease Questionnaire

    Time frame: Eight weeks

    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.

  2. Gastroesophageal Reflux Disease- Quality of Life

    Time frame: Eight weeks

    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.

Secondary outcomes

  1. The Hospital Anxiety and Depression Scale

    Time frame: Eight weeks

    The Hospital Anxiety and Depression Scale will be used to assess anxiety and depression. HADS was developed to assess anxiety disorders and depression in patients in hospital clinics other than psychiatry. Each question in the scale, consisting of a total of 14 questions, is evaluated between 0 and 3 points. Increasing scores represent higher levels of anxiety and depression.

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Registry information

Official study title

Effects of Diaphragmatic Breathing and Relaxation Exercises in Patients With Gastroesophageal Reflux

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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