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

Not Applicable

Completed

• Conditions: GERD; Post COVID-19 Condition; Diaphragm Issues
• Interventions: Other: modified diaphragmatic training; Other: standard diaphragmatic training

• Registration Number: NCT05833243
• Lead Sponsor: Indonesia University

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

Study Timeline

• Study Start: 2023-02-08
• Status Verified: 2023-04
• Primary Completion: 2023-04-14
• Study Completion: 2023-04-18
• Study First Submitted: 2023-04-25
• Study First Submitted QC: 2023-04-25
• Last Update Submitted: 2023-04-26
• Study First Posted: 2023-04-27
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Group	modified diaphragmatic training	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.
Control Group	standard diaphragmatic training	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.

Primary Outcome Measures

Name	Time	Method
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 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 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

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine, Universitas Indonesia; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia