- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07927543
Effects of Breathing and Core Stabilization Exercises in Gastroesophageal Reflux Disease
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.
연구 개요
상태
상세 설명
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).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Nurcan Contarli, PhD
- 전화번호: +90 370 418 9171
- 이메일: nurcancontarli@karabuk.edu.tr
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: control group
No exercise intervention will be applied to the control group. |
|
|
실험적: diaphragmatic breathing exercise group
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. |
|
실험적: 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. |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The Gastroesophageal Reflux Disease Questionnaire (GERD-Q)
기간: 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
기간: 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)
기간: 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
|
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Postural analysis
기간: 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)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
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추가 정보
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