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Effects of Breathing and Core Stabilization Exercises in Gastroesophageal Reflux Disease

2026年11月4日 更新者:Nurcan Contarli、Karabuk University

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.

研究概览

详细说明

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).

研究类型

介入性

注册 (估计的)

51

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
无干预:control group

No exercise intervention will be applied to the control group.

实验性的: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.

实验性的: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The Gastroesophageal Reflux Disease Questionnaire (GERD-Q)
大体时间: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
大体时间: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)
大体时间: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
Postural analysis
大体时间: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)
大体时间: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)
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月20日

初级完成 (估计的)

2027年3月30日

研究完成 (估计的)

2027年4月10日

研究注册日期

首次提交

2026年11月4日

首先提交符合 QC 标准的

2026年11月4日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • KBU-FTR-NC-08

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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