Effect of Pulmonary Rehabilitation Among Post-COVID-19 Patients in a Tertiary Care Hospital in Bangladesh

NCT06004310 | Completed DMC

• 1 other identifier: 683
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This quasi-experimental study aims to evaluate the efficacy and safety of pulmonary rehabilitation in post-COVID-19 patients and compare differences in primary outcomes before and after pulmonary rehabilitation. Its main aim is to provide an answer to the following question: What are the outcomes of pulmonary rehabilitation in post-COVID-19 patients in a tertiary care facility in Bangladesh? The participants will participate in 06 weeks of comprehensive multimodal and multidisciplinary outpatient pulmonary rehabilitation, including endurance training, strength training, patient education, relaxation techniques, psychological support, and nutritional counseling.

Conditions

Pulmonary Pathology

Keywords

Pulmonary rehabilitation,Post-COVID-19 patients,Bangladesh

Outcome Measures

Primary Outcomes (4)

• Distance: Six-minute walking test (6MWT)

  The following equipment will be required: Stopwatch, Measuring/trundle wheel to measure distance covered, A 30-meter stretch of unimpeded walkway, Two cones to mark the space that needs to be covered, Pulse oximeter for measuring heart rate and SpO2, Borg Breathlessness Scale

  After enrollment and after 6 weeks when complete the pulmonary rehabilitation

• Respiratory outcomes: FVC, FEV1, FEV1/FVC ratio, DLCO

  FVC (Forced vital capacity) - This is the amount of air exhaled forcefully and quickly after inhaling as much as patient can. FEV1 (Forced expiratory volume in 1 second ) - The maximum amount of air that the subject can forcibly expel during the first second following maximal inhalation. FEV1/FVC ratio - The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs DLCO (Diffusing lung capacity for carbon monoxide) - The ability of the lungs to transfer gas from inhaled air to the red blood cells in pulmonary capillaries.

  After enrollment and after 6 weeks when complete the pulmonary rehabilitation

• Quality of life: Short Form 36 Health Survey Questionnaire (SF-36)

  SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.

  After enrollment and after 6 weeks when complete the pulmonary rehabilitation

• Laboratory investigations: CRP and D-dimer

  CRP (C reactive protein) - A c-reactive protein test measures the level of c-reactive protein (CRP) in a sample of patient's blood D-dimer - A D-dimer test looks for D-dimer in blood. D-dimer is a protein fragment (small piece) that's made when a blood clot dissolves in body.

  After enrollment and after 6 weeks when complete the pulmonary rehabilitation

Study Arms (1)

Post-COVID-19 Patients

EXPERIMENTAL

Post-COVID-19 patients are individuals who have recovered from the acute phase of COVID-19 but continue to experience lingering symptoms and health challenges for weeks or even months after their initial infection. These individuals are often referred to as "long haulers" or "post-acute sequelae of SARS-CoV-2 infection" (PASC) patients. The symptoms experienced by post-COVID-19 patients can vary widely and may include fatigue, shortness of breath, chest pain, joint pain, cognitive difficulties, and more. Medical professionals and researchers are working to better understand and address these conditions, providing supportive care and rehabilitation to help these patients regain their health and well-being.

Behavioral: Pulmonary Rehabilitation

Interventions

Pulmonary Rehabilitation BEHAVIORAL

Participants will be participated a 06 weeks comprehensive outpatient pulmonary rehabilitation which includes endurance training, strength training, patient education, relaxation techniques, psychological support and nutritional counselling.

Post-COVID-19 Patients

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously RT-PCR positive for SARS-COV-2 and whose respiratory symptoms (fatigue, exertional shortness of breath and cough) persists more than 3 weeks after the onset of their first symptoms attending outpatient and admitted inpatient under the department of Respiratory Medicine, Bangabandhu Sheikh Mujib Medical University, Bangladesh

You may not qualify if:

• RT-PCR negative but respiratory symptoms (fatigue, exertional shortness of breath and cough) persists more than 3 weeks after the onset of their first symptoms
• RT-PCR positive but respiratory symptoms (fatigue, exertional shortness of breath and cough) not persists more than 3 weeks after the onset of their first symptoms
• Comorbidities like chronic lung disease, obstructive sleep apnea, coronary heart disease, chronic kidney disease, stroke

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, Shahbag, 1000, Bangladesh

Location

Study Officials

• Mohammed A Rahman, MBBS,MD,FCCP

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Respiratory Medicine

Model Details: The study will be a quasi-experimental study and carried out at Bangabandhu Sheikh Mujib Medical University. A consecutive sampling method will be used. The participants will engage in a comprehensive 06-weeks outpatient multimodal and multidisciplinary pulmonary rehabilitation program.

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 22, 2023
• Study Start: May 25, 2023
• Primary Completion: July 25, 2024
• Study Completion: September 24, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)