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

April 26, 2023 updated by: Siti Chandra Widjanantie, Indonesia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Faculty of Medicine, Universitas Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of GERD-Q Score after 4 weeks
Time Frame: base line and week 4
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
Time Frame: base line and week 4
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
Time Frame: base line and week 4
The maximal pressure of inspiratory muscle strength that related to diaphragm strength
base line and week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of Lung function (FEV1, FVC and ratio FEV1/FVC) after 4 weeks
Time Frame: base line and week 4
the improvement of FEV1, FVC and ratio FEV1/FVC
base line and week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Siti C Widjanantie, MD, Fakultas Kedokteran Universitas Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2023

Primary Completion (Actual)

April 14, 2023

Study Completion (Actual)

April 18, 2023

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-11-1417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol and Study Outcome

IPD Sharing Time Frame

4 weeks

IPD Sharing Access Criteria

by request to my email: sitichandraw@gmail.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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