Reflux Disease, Gastro-EsophagealNCT06812650
Breathing Exercises in Patients With Gastroesophageal Reflux
A study testing Medical treatment and Exercise in people with Reflux Disease, Gastro-Esophageal, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Reflux Disease, Gastro-Esophageal
- What is being tested?
- Medical treatment and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2025to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals with a history of gastrointestinal surgery
- Individuals who are pregnant or breastfeeding
- Individuals who have hiatal hernia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Diaphragmatic Breathing and Relaxation 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.
Read the 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
- Being tested
- Medical treatment, Exercise
- Keywords
- Breathing Exercises, Relaxation, Quality of Life, Anxiety
- Medical subject headings
- Gastroesophageal Reflux, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical treatmentOther
Patients will continue their routine medical treatment for gastroesophageal reflux disease.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Medical Treatment | Active comparator | Not described Receives: Other: Medical treatment |
| Exercise | Experimental | The exercise program will consist of diaphragmatic breathing exercises and progressive muscle relaxation exercises. Receives: Other: Medical treatment; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Eight weeks
Secondary outcomes (1)
The Hospital Anxiety and Depression Scale
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.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start3 Feb 2025
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflux Disease, Gastro-EsophagealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Ozmen, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812650
- Sponsor's protocol ID
- KBU-FTR-2024/1814
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diaphragmatic Breathing and Relaxation Exercises in Patients With Gastroesophageal Reflux
- ClinicalTrials.gov ID
- NCT06812650
- Acronym / sponsor ID
- KBU-FTR-2024/1814
- Conditions
- Reflux Disease, Gastro-Esophageal
- Keywords
- Breathing Exercises, Relaxation, Quality of Life, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Treatment | Active comparator | Other: Medical treatment |
| Exercise | Experimental | Other: Medical treatment, Other: ExerciseThe exercise program will consist of diaphragmatic breathing exercises and progressive muscle relaxation exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Individuals with a history of gastrointestinal surgery
- Individuals who are pregnant or breastfeeding
- Individuals who have hiatal hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical treatmentPatients will continue their routine medical treatment for gastroesophageal reflux disease. | Other | Exercise, Medical Treatment |
| ExerciseThe 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. | Other | Exercise |
Primary outcome
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.
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.
1 secondary outcome
The Hospital Anxiety and Depression Scale
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical treatment and Exercise in people with Reflux Disease, Gastro-Esophageal, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastroesophageal Reflux Disease Questionnaire (time frame: Eight weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.