Breathing Exercises in Patients With Gastroesophageal Reflux

NCT ID: NCT06812650

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2025-05-15

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.

Detailed Description

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.

Conditions

Reflux Disease, Gastro-Esophageal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medical Treatment

Group Type: ACTIVE_COMPARATOR

Medical treatment

Intervention Type: OTHER

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

Exercise

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

Group Type: EXPERIMENTAL

Medical treatment

Intervention Type: OTHER

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

Exercise

Intervention Type: 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.

Interventions

Medical treatment

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

Intervention Type: OTHER

Exercise

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karabuk University

OTHER

Sponsor Role: lead

Responsible Party

Tarik Ozmen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Private Maras Health Services

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KBU-FTR-2024/1814

Identifier Type: -

Identifier Source: org_study_id