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

GERD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05833243
• Other study ID #: 22-11-1417
• Status: Completed
• Phase: N/A
• Start date: February 8, 2023
• Est. completion date: April 18, 2023

Study information

• Verified date: April 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 18, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Diaphragm Issues
• Gastroesophageal Reflux
• GERD

Intervention

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.
• 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.

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine, Universitas Indonesia	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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