Effectiveness of Modified Diaphragmatic Training for Gastroesophageal Reflux Disease Post Covid-19
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Interventional Group 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
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.
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Active Comparator: Control Group 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
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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Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female after recover from moderate COVID-19.
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Six month post COVID-19
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Age 18 to 60 years old
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GERD-Q Score more than 7
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Agree to participate in the study
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Well understanding of the study procedure.
Exclusion Criteria:
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History of ventilator used while COVID
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History of uncontrolled cardiac problems and chronic pulmonary
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Pregnancy or lactation
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History of surgery in the abdomen of the thoracic area
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Severe scoliosis or Kyphotic
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HIV/ AIDS, Autoimmune
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Prolonged use of dyslipidemia drug more than 1 year
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Prolonged use of prokinetic gastric drug more than 4 weeks
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Faculty of Medicine, Universitas Indonesia | Jakarta Pusat | DKI Jakarta | Indonesia | 10430 |
Sponsors and Collaborators
- Indonesia University
Investigators
- Principal Investigator: Siti C Widjanantie, MD, Fakultas Kedokteran Universitas Indonesia
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 22-11-1417