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

Study Overview
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Brief Summary
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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.

Detailed Description
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Background: The 2019 novel coronavirus, belonging to the β species of coronaviruses, primarily spreads through respiratory droplets and close contact. Even after recovering from the infection, COVID-19 can lead to various chronic health issues, with impaired lung function, reduced exercise performance, and diminished quality of life being prevalent among a significant proportion of patients. In Bangladesh, post-COVID-19 patients represent a considerable population who have overcome the acute phase of the infection but continue to face numerous social, psychological, and physical challenges. Among these challenges, respiratory complications such as persistent cough, shortness of breath, and decreased lung function are frequently observed in post-COVID-19 patients in Bangladesh. In addition, these individuals often experience fatigue, muscle weakness, and joint pain. These physical symptoms can profoundly impact their daily activities and overall quality of life, necessitating ongoing medical care and rehabilitation. Purpose: To evaluate the efficacy of pulmonary rehabilitation in post-COVID-19 patients and to compare differences in outcomes between before and after pulmonary rehabilitation Methodology: It will be a hospital-based quasi-experimental study. The investigator will conveniently select adult post-COVID-19 patients whose respiratory symptoms (fatigue, exertional dyspnea, etc.) persist longer than 12 weeks from the onset of their first symptoms from outpatient and inpatient of the Department of Respiratory Medicine, Bangabandhu Sheikh Mujib Medical University. Participants will participate in a 06-weeks (Two sessions per week) comprehensive multimodal and multidisciplinary outpatient pulmonary rehabilitation. In-person interviews will be done for data collection. The total sample size will be 130. Before the study, the research protocol will be approved by the Institutional Review Board (IRB) of Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka. Expected outcome: The study's findings will reveal the benefits of pulmonary rehabilitation among post-COVID-19 patients.

Official Title
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Effect of Pulmonary Rehabilitation Among Post-COVID-19 Patients in a Tertiary Care Hospital in Bangladesh: A Quasi-Experimental Study

Conditions
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Pulmonary Pathology

Intervention / Treatment
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* Behavioral: Pulmonary Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post-COVID-19 Patients<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary rehabilitation,Post-COVID-19 patients,Bangladesh