Pulmonary PathologyNCT06004310
Effect of Pulmonary Rehabilitation Among Post-COVID-19 Patients in a Tertiary Care Hospital in Bangladesh
A study testing Pulmonary Rehabilitation in people with Pulmonary Pathology, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pulmonary Pathology
- What is being tested?
- Pulmonary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBangladesh
- Study dates
- 25 May 2023to 24 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Bangabandhu Sheikh Mujib Medical University
Dhaka, Shahbag, 1000
About this study
Official title: Effect of Pulmonary Rehabilitation Among Post-COVID-19 Patients in a Tertiary Care Hospital in Bangladesh: A Quasi-Experimental Study
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.
Read the 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.
- Conditions
- Pulmonary Pathology
- Being tested
- Pulmonary Rehabilitation
- Keywords
- Pulmonary rehabilitation,Post-COVID-19 patients,Bangladesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After enrollment and after 6 weeks when complete the pulmonary rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start25 May 2023
- Primary completion25 Jul 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary PathologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Mohammed Atiqur Rahman, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Mohammed A Rahman, MBBS,MD,FCCP, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004310
- Sponsor's protocol ID
- 683
- Status last verified
- Oct 2024
- First submitted
- 17 Aug 2023
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulmonary Rehabilitation Among Post-COVID-19 Patients in a Tertiary Care Hospital in Bangladesh: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT06004310
- Acronym / sponsor ID
- 683
- Conditions
- Pulmonary Pathology
- Keywords
- Pulmonary rehabilitation,Post-COVID-19 patients,Bangladesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Post-COVID-19 Patients | Experimental | Behavioral: Pulmonary RehabilitationPost-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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary RehabilitationParticipants 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. | Behavioural | Post-COVID-19 Patients |
Primary outcome
Distance: Six-minute walking test (6MWT)
Time frame: After enrollment and after 6 weeks when complete the pulmonary rehabilitation
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
Time frame: After enrollment and after 6 weeks when complete the pulmonary rehabilitation
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)
Time frame: After enrollment and after 6 weeks when complete the pulmonary rehabilitation
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
Laboratory investigations: CRP and D-dimer
Time frame: After enrollment and after 6 weeks when complete the pulmonary rehabilitation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed A Rahman, MBBS,MD,FCCP principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation in people with Pulmonary Pathology, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance: Six-minute walking test (6MWT) (time frame: After enrollment and after 6 weeks when complete the pulmonary rehabilitation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.