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

Primary Purpose

Pulmonary Pathology

Status
Active
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Pathology focused on measuring Pulmonary rehabilitation,Post-COVID-19 patients,Bangladesh

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bangabandhu Sheikh Mujib Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Post-COVID-19 Patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 17, 2023
Last Updated
August 21, 2023
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT06004310
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
January 25, 2024 (Anticipated)
Study Completion Date
May 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Pathology
Keywords
Pulmonary rehabilitation,Post-COVID-19 patients,Bangladesh

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Post-COVID-19 Patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Distance: Six-minute walking test (6MWT)
Description
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
Time Frame
After enrollment and after 6 weeks when complete the pulmonary rehabilitation
Title
Respiratory outcomes: FVC, FEV1, FEV1/FVC ratio, DLCO
Description
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.
Time Frame
After enrollment and after 6 weeks when complete the pulmonary rehabilitation
Title
Quality of life: Short Form 36 Health Survey Questionnaire (SF-36)
Description
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
Time Frame
After enrollment and after 6 weeks when complete the pulmonary rehabilitation
Title
Laboratory investigations: CRP and D-dimer
Description
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.
Time Frame
After enrollment and after 6 weeks when complete the pulmonary rehabilitation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed A Rahman, MBBS,MD,FCCP
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bangabandhu Sheikh Mujib Medical University
City
Dhaka
State/Province
Shahbag
ZIP/Postal Code
1000
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No

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

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