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Completed

NCT Number: NCT05833243

Effectiveness of Modified Diaphragmatic Training for Gastroesophageal Reflux Disease Post 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.

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Key information

Conditions

GERD Deglutition Disorders Diaphragm Issues Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Post COVID-19 Condition

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

modified diaphragmatic training

Other

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

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2023
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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