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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Group | Experimental | 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. |
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| Control Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified diaphragmatic training | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siti C Widjanantie, MD | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Universitas Indonesia | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35382885 | Background | Kader M, Hossain MA, Reddy V, Perera NKP, Rashid M. Effects of short-term breathing exercises on respiratory recovery in patients with COVID-19: a quasi-experimental study. BMC Sports Sci Med Rehabil. 2022 Apr 5;14(1):60. doi: 10.1186/s13102-022-00451-z. | |
| 36628181 | Background | Saha S, Sharma K. Modification of Lifestyle to Recover from Post-COVID Symptoms: A Short Review. J Lifestyle Med. 2022 Sep 30;12(3):113-118. doi: 10.15280/jlm.2022.12.3.113. |
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Study Protocol and Study Outcome
4 weeks
by request to my email: sitichandraw@gmail.com
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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Intervention Group (modified diaphragmatic training) and control group (standard diaphragmatic training)
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single-blinded, only the investigator was blinded, using a randomization center for concealment.
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| standard diaphragmatic training | Other | 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. |
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| 32233626 | Background | Qiu K, Wang J, Chen B, Wang H, Ma C. The effect of breathing exercises on patients with GERD: a meta-analysis. Ann Palliat Med. 2020 Mar;9(2):405-413. doi: 10.21037/apm.2020.02.35. Epub 2020 Mar 17. |
| D004066 | Digestive System Diseases |