Clinical trial NCT06004310: Effect of Pulmonary Rehabilitation Among Post-COVID-19 Patients in a Tertiary Care Hospital in Bangladesh
Official title: Effect of Pulmonary Rehabilitation Among Post-COVID-19 Patients in a Tertiary Care Hospital in Bangladesh: A Quasi-Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Pathology
Keywords: Pulmonary rehabilitation,Post-COVID-19 patients,Bangladesh
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Distance: Six-minute walking test (6MWT)
timeFrame: After enrollment and after 6 weeks when complete the pulmonary rehabilitation
measure: Respiratory outcomes: FVC, FEV1, FEV1/FVC ratio, DLCO
timeFrame: After enrollment and after 6 weeks when complete the pulmonary rehabilitation
measure: Quality of life: Short Form 36 Health Survey Questionnaire (SF-36)
timeFrame: After enrollment and after 6 weeks when complete the pulmonary rehabilitation
measure: Laboratory investigations: CRP and D-dimer
timeFrame: After enrollment and after 6 weeks when complete the pulmonary rehabilitation
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Bangabandhu Sheikh Mujib Medical University
state: Shahbag
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Mohammed A Rahman, MBBS,MD,FCCP
role: PRINCIPAL_INVESTIGATOR
References: