Clinical trial NCT05833243: Effectiveness of Modified Diaphragmatic Training for Gastroesophageal Reflux Disease Post Covid-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GERD
Post COVID-19 Condition
Diaphragm Issues
Keywords: Diaphragmatic Training
GERD-Q Score
Diaphragmatic Excursion
Maximal Inspiratory Pressure
Lung Function
GERD After COVID-19
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention Group (modified diaphragmatic training) and control group (standard diaphragmatic training)
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of GERD-Q Score after 4 weeks
timeFrame: base line and week 4
measure: Change from baseline of Diaphragmatic Excursion after 4 weeks
timeFrame: base line and week 4
measure: Change from baseline of Maximal Inspiratory Pressure after 4 weeks
timeFrame: base line and week 4
Secondary outcomes:
measure: Change from baseline of Lung function (FEV1, FVC and ratio FEV1/FVC) after 4 weeks
timeFrame: base line and week 4
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Faculty of Medicine, Universitas Indonesia
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Siti C Widjanantie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.