Effectiveness of Modified Diaphragmatic Training for Improving GERD-Q Score, Diaphragmatic Excursion, Maximum Inspiratory Pressure and Lung Function in Adults With Gastroesophageal Reflux Disease After Covid-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline of GERD-Q Score after 4 weeks
研究概览
简要总结
The study titled "Effectiveness of Modified Diaphragmatic Training for Improving GERD-Q Score, Diaphragmatic Excursion, Maximum Inspiratory Pressure and Lung Function in Adults With Gastroesophageal Reflux Disease After Covid-19: a Single-blinded Randomized Control Trial" is a clinical trial that aimed to investigate the effectiveness of 4 weeks modified diaphragmatic training (MDT) compare with standard diaphragmatic training for improving GERD-Q score, diaphragmatic excursion, maximum inspiratory pressure, and lung function in adults with gastroesophageal reflux disease (GERD) after COVID-19. The trial was single-blinded and randomized, and it included a total of 50 participants. The results of the study showed that MDT was effective in improving GERD-Q score, diaphragmatic excursion, maximum inspiratory pressure, and lung function in adults with GERD after COVID-19.
详细描述
The study aims to investigate the effectiveness of modified diaphragmatic training compared with standard diaphragmatic training in adults with gastroesophageal reflux disease after covid-19. The design is a single-center in a national respiratory referral center in Indonesia, single-blinded randomized control trial. A central randomization center used computer-generated tables to allocate treatments. The study will involve a randomized controlled trial with a sample size of 50 adult patients with GERD after covid-19. Participants will be randomly assigned to either a modified diaphragmatic training group or a control group.
Four weeks of training with diaphragmatic training followed by modified diaphragmatic training (MDT) or standard diaphragmatic training. Follow-up 30 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
single-blinded, only the investigator was blinded, using a randomization center for concealment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female after recover from moderate COVID-
- •Six month post COVID-19
- •Age 18 to 60 years old
- •GERD-Q Score more than 7
- •Agree to participate in the study
- •Well understanding of the study procedure.
排除标准
- •History of ventilator used while COVID
- •History of uncontrolled cardiac problems and chronic pulmonary
- •Pregnancy or lactation
- •History of surgery in the abdomen of the thoracic area
- •Severe scoliosis or Kyphotic
- •HIV/ AIDS, Autoimmune
- •Prolonged use of dyslipidemia drug more than 1 year
- •Prolonged use of prokinetic gastric drug more than 4 weeks
研究组 & 干预措施
Interventional Group
Baseline measurement will be done in the rehabilitation center. Participants will receive modified diaphragmatic training using modified diaphragmatic training with increased load every week for strength training (60% from inspiratory muscle strength).
Weekly follow-up will be taken to reassure the respiratory muscle strength. Prescription for intervention will be determined based on the result of baseline measurement.
After 4 weeks post-intervention measurement will be taken.
干预措施: modified diaphragmatic training (Other)
Control Group
Baseline measurement will be done in the rehabilitation center. Participants will receive standard diaphragmatic training using a sitting position.
Weekly follow-ups will be taken to remeasure the respiratory muscle strength and training procedure.
After 4 weeks post-intervention measurements will be taken.
干预措施: standard diaphragmatic training (Other)
结局指标
主要结局
Change from baseline of GERD-Q Score after 4 weeks
时间窗: base line and week 4
GERD was diagnosed when the GERD-Q score is above or equal with 8
Change from baseline of Diaphragmatic Excursion after 4 weeks
时间窗: base line and week 4
The increase of diaphragm range of movement during inspiration and expiration
Change from baseline of Maximal Inspiratory Pressure after 4 weeks
时间窗: base line and week 4
The maximal pressure of inspiratory muscle strength that related to diaphragm strength
次要结局
- Change from baseline of Lung function (FEV1, FVC and ratio FEV1/FVC) after 4 weeks(base line and week 4)
研究者
Siti Chandra Widjanantie
Principal Investigator
Indonesia University