Diaphragm Issues, GERD, Post COVID-19 Condition
Conditions
Keywords
Diaphragmatic Training, GERD-Q Score, Diaphragmatic Excursion, Maximal Inspiratory Pressure, Lung Function, GERD After COVID-19
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
Interventions
OTHERmodified diaphragmatic training
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.
OTHERstandard diaphragmatic training
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.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
single-blinded, only the investigator was blinded, using a randomization center for concealment.
Intervention model description
Intervention Group (modified diaphragmatic training) and control group (standard diaphragmatic training)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Indonesia
Outcome results
None listed