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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Modified diaphragmatic strength training prescriptions will be given based on the result of baseline assessment. The intensity is 60% from the maximum respiratory muscle strength from baseline and weekly remeasurement. Participants are asked to come for weekly follow-up and commit to do at least 20 sessions of exercise. The training is under supervision of physical medicine and rehabilitation specialist.
standard diaphragmatic strength training prescriptions will be given as daily routine, 3 times a day. Participants are asked to come for weekly follow-up and commit to do at least 20 sessions of exercise. The training is under supervision of physical medicine and rehabilitation specialist.
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia
Change from baseline of GERD-Q Score after 4 weeks
GERD was diagnosed when the GERD-Q score is above or equal with 8
Time frame: base line and week 4
Change from baseline of Diaphragmatic Excursion after 4 weeks
The increase of diaphragm range of movement during inspiration and expiration
Time frame: base line and week 4
Change from baseline of Maximal Inspiratory Pressure after 4 weeks
The maximal pressure of inspiratory muscle strength that related to diaphragm strength
Time frame: base line and week 4
Change from baseline of Lung function (FEV1, FVC and ratio FEV1/FVC) after 4 weeks
the improvement of FEV1, FVC and ratio FEV1/FVC
Time frame: base line and week 4
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