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

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT05833243
Collaborator
(none)
50
1
2
2.3
22.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: modified diaphragmatic training
  • Other: standard diaphragmatic training
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Intervention Group (modified diaphragmatic training) and control group (standard diaphragmatic training)Intervention Group (modified diaphragmatic training) and control group (standard diaphragmatic training)
Masking:
Single (Investigator)
Masking Description:
single-blinded, only the investigator was blinded, using a randomization center for concealment.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 8, 2023
Actual Primary Completion Date :
Apr 14, 2023
Actual Study Completion Date :
Apr 18, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine, Universitas Indonesia Jakarta Pusat DKI Jakarta Indonesia 10430

Sponsors and Collaborators

  • Indonesia University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Siti Chandra Widjanantie, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier:
NCT05833243
Other Study ID Numbers:
  • 22-11-1417
First Posted:
Apr 27, 2023
Last Update Posted:
Apr 28, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Siti Chandra Widjanantie, Principal Investigator, Indonesia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2023