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

NCT05833243 | Completed DMC

• 1 other identifier: 22-11-1417
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

GERD; Post COVID-19 Condition; Diaphragm Issues

Keywords

Diaphragmatic Training; GERD-Q Score; Diaphragmatic Excursion; Maximal Inspiratory Pressure; Lung Function; GERD After COVID-19

Outcome Measures

Primary Outcomes (3)

• Change from baseline of GERD-Q Score after 4 weeks

  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

  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

  The maximal pressure of inspiratory muscle strength that related to diaphragm strength

  base line and week 4

Secondary Outcomes (1)

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

  base line and week 4

Study Arms (2)

Interventional Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

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.

Interventional Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (3)

• 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.

  PMID: 35382885 BACKGROUND

• 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.

  PMID: 36628181 BACKGROUND

• 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.

  PMID: 32233626 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Siti C Widjanantie, MD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: single-blinded, only the investigator was blinded, using a randomization center for concealment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention Group (modified diaphragmatic training) and control group (standard diaphragmatic training)

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: April 27, 2023
• Study Start: February 8, 2023
• Primary Completion: April 14, 2023
• Study Completion: April 18, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 4 weeks
• Access Criteria: by request to my email: sitichandraw@gmail.com

Locations

ID (1)