Effectiveness of Modified Diaphragmatic Training for Gastroesophageal Reflux Disease Post Covid-19
- Conditions
- GERDPost COVID-19 ConditionDiaphragm Issues
- Registration Number
- NCT05833243
- Lead Sponsor
- Indonesia University
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Male and female after recover from moderate COVID-19.
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline of GERD-Q Score after 4 weeks 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 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 base line and week 4 The maximal pressure of inspiratory muscle strength that related to diaphragm strength
- Secondary Outcome Measures
Name Time Method Change from baseline of Lung function (FEV1, FVC and ratio FEV1/FVC) after 4 weeks base line and week 4 the improvement of FEV1, FVC and ratio FEV1/FVC
Trial Locations
- Locations (1)
Faculty of Medicine, Universitas Indonesia
🇮🇩Jakarta Pusat, DKI Jakarta, Indonesia
Faculty of Medicine, Universitas Indonesia🇮🇩Jakarta Pusat, DKI Jakarta, Indonesia