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

University of Indonesia (UI)

Status: Completed

Conditions: Diaphragm Issues; Post COVID-19 Condition; GERD

Treatments: Other: modified diaphragmatic training; Other: standard diaphragmatic training

Study type: Interventional

Funder types: Other

Identifiers

NCT05833243

22-11-1417

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Interventional Group

Experimental group

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.

Treatment:

Other: modified diaphragmatic training

Control Group

Active Comparator group

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.

Treatment:

Other: standard diaphragmatic training