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

NCT ID: NCT05833243

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-08

Study Completion Date

2023-04-18

Brief Summary

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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

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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

Conditions

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GERD Post COVID-19 Condition Diaphragm Issues

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention Group (modified diaphragmatic training) and control group (standard diaphragmatic training)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
single-blinded, only the investigator was blinded, using a randomization center for concealment.

Study Groups

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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.

Group Type EXPERIMENTAL

modified diaphragmatic training

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

standard diaphragmatic training

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Siti Chandra Widjanantie

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Siti C Widjanantie, MD

Role: PRINCIPAL_INVESTIGATOR

Fakultas Kedokteran Universitas Indonesia

Locations

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Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND
PMID: 35382885 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36628181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32233626 (View on PubMed)

Other Identifiers

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22-11-1417

Identifier Type: -

Identifier Source: org_study_id