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

Primary Purpose

GERD, Post COVID-19 Condition, Diaphragm Issues

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
modified diaphragmatic training
standard diaphragmatic training
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for GERD focused on measuring Diaphragmatic Training, GERD-Q Score, Diaphragmatic Excursion, Maximal Inspiratory Pressure, Lung Function, GERD After COVID-19

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine, Universitas Indonesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline of GERD-Q Score after 4 weeks
GERD was diagnosed when the GERD-Q score is above or equal with 8
Change from baseline of Diaphragmatic Excursion after 4 weeks
The increase of diaphragm range of movement during inspiration and expiration
Change from baseline of Maximal Inspiratory Pressure after 4 weeks
The maximal pressure of inspiratory muscle strength that related to diaphragm strength

Secondary Outcome Measures

Change from baseline of Lung function (FEV1, FVC and ratio FEV1/FVC) after 4 weeks
the improvement of FEV1, FVC and ratio FEV1/FVC

Full Information

First Posted
April 25, 2023
Last Updated
April 26, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05833243
Brief Title
Effectiveness of Modified Diaphragmatic Training for Gastroesophageal Reflux Disease Post Covid-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
April 14, 2023 (Actual)
Study Completion Date
April 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD, Post COVID-19 Condition, Diaphragm Issues
Keywords
Diaphragmatic Training, GERD-Q Score, Diaphragmatic Excursion, Maximal Inspiratory Pressure, Lung Function, GERD After COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention Group (modified diaphragmatic training) and control group (standard diaphragmatic training)
Masking
Investigator
Masking Description
single-blinded, only the investigator was blinded, using a randomization center for concealment.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
modified diaphragmatic training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
standard diaphragmatic training
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline of GERD-Q Score after 4 weeks
Description
GERD was diagnosed when the GERD-Q score is above or equal with 8
Time Frame
base line and week 4
Title
Change from baseline of Diaphragmatic Excursion after 4 weeks
Description
The increase of diaphragm range of movement during inspiration and expiration
Time Frame
base line and week 4
Title
Change from baseline of Maximal Inspiratory Pressure after 4 weeks
Description
The maximal pressure of inspiratory muscle strength that related to diaphragm strength
Time Frame
base line and week 4
Secondary Outcome Measure Information:
Title
Change from baseline of Lung function (FEV1, FVC and ratio FEV1/FVC) after 4 weeks
Description
the improvement of FEV1, FVC and ratio FEV1/FVC
Time Frame
base line and week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siti C Widjanantie, MD
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Universitas Indonesia
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
35382885
Citation
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.
Results Reference
background
PubMed Identifier
36628181
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.
Results Reference
background
PubMed Identifier
32233626
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.
Results Reference
background

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

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