Effectiveness of Modified Diaphragmatic Training for Gastroesophageal Reflux Disease Post Covid-19

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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GERD, Post COVID-19 Condition, Diaphragm Issues

Intervention / Treatment
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* Other: modified diaphragmatic training
* Other: standard diaphragmatic training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention Group (modified diaphragmatic training) and control group (standard diaphragmatic training)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Group<br>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. | Other: modified diaphragmatic training<br>* 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.<br>|
| Active Comparator: Control Group<br>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. | Other: standard diaphragmatic training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of GERD-Q Score after 4 weeks | GERD was diagnosed when the GERD-Q score is above or equal with 8 | 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 | 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 | base line and week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Lung function (FEV1, FVC and ratio FEV1/FVC) after 4 weeks | the improvement of FEV1, FVC and ratio FEV1/FVC | base line and week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diaphragmatic Training, GERD-Q Score, Diaphragmatic Excursion, Maximal Inspiratory Pressure, Lung Function, GERD After COVID-19