Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001372875
Ethics application status
Approved
Date submitted
18/09/2021
Date registered
11/10/2021
Date last updated
13/02/2023
Date data sharing statement initially provided
11/10/2021
Date results information initially provided
13/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Supervised Breathing Exercise on the Patients with COVID-19 Infection.
Scientific title
Effects of Supervised Breathing Exercise on the Patients with COVID-19 Infection-A Randomized Controlled Trial.
Secondary ID [1] 305289 0
None
Universal Trial Number (UTN)
Trial acronym
ESBEC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory infection 323593 0
COVID-19 323594 0
Condition category
Condition code
Physical Medicine / Rehabilitation 321137 321137 0 0
Physiotherapy
Respiratory 321297 321297 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Breathing exercises: Breathing exercises will be provided as intervention along with standard treatment, and it will be given by the same Physiotherapist for an individual patient under direct supervision of a Physiatrist. Breathing exercises will be delivered daily for 4 weeks, each session is anticipated to take 12 minutes to complete. And a Bangla written Breathing exercises procedure with pictures of 4 pages document (which is designed for this study only) will be provided to the patients who will be treated at home & they will be supervised virtually over video calls. Breathing exercises is as follows: 1. Breathing control, 2. Deep breathing exercise, 3. Pursed lip breathing exercise, 4. Training to Controlled cough, 5. Expansion breathing exercise and 6. Blowing exercise. These are the intervention for one group along with standard treatment and other group will be treated with standard treatment only as per WHO guideline.
Intervention code [1] 321756 0
Rehabilitation
Comparator / control treatment
The control group will be provided standard treatment for COVID-19 as per WHO guideline according to breathing difficulty. Standard treatment will be given according to the symptoms of the patients which include o2 therapy, paracetamol, antihistamine, heparin, steroid, antibiotic as necessary for the patients and as prescribed by the COVID concerned physicians.
Control group
Active

Outcomes
Primary outcome [1] 329000 0
Difficulty in breathing will be assessed by using Modified Medical Research Council (MMRC) scale.
Timepoint [1] 329000 0
At the first attendance (week one) with week 2, 3 and 4 ( primary time point) post-enrolment.
Secondary outcome [1] 401127 0
Modified Borg Scale (MBS) to determine the breathing difficulty after intervention with breathing exercise.
Timepoint [1] 401127 0
At first attendance (week one) with week 2, 3 and 4 (post-enrolment)
Secondary outcome [2] 401384 0
Lung complications which will be assessed by clinical symptoms, clinical examination along with investigations of the patient.
Timepoint [2] 401384 0
Pre treatment and weekly and post treatment

Eligibility
Key inclusion criteria
• Nasopharyngeal swab samples (tested by RT-PCR) positive for the COVID-19.
• Subjects Aged 15 years or more of all genders.
• O2 saturation as measured by pulse oximetry (SpO2) greater than 90 % in room air.
• Patients having symptoms mild to moderate in nature
• A resting respiratory rate 30/m or less than 30/m.
• Able to realize the content of questionnaires and who will provide consent.
Minimum age
15 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Subjects aged more than 70 years of all genders.
• Subjects having severe form of COVID-19
• Subjects having severe COPD bronchial asthma and severe ischemic heart disease.
.• Chronic liver and kidney disease
• Pregnant or lactating women
• Patients admitted in ICU

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will not be concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be done by the way of lottery. There will some cards denoting group and by drawing the card bearing the group will be designated.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data will be expressed as percentage, frequency and mean ± standard deviation (SD). Both student’s ‘t’ test and Chi-square test ( as required) will be used to compare the groups by testing different variables. P value < 0.05 will be considered as significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2021
Actual
15/11/2021
Date of last participant enrolment
Anticipated
1/12/2021
Actual
15/07/2022
Date of last data collection
Anticipated
31/12/2021
Actual
15/09/2022
Sample size
Target
100
Accrual to date
Final
110
Recruitment outside Australia
Country [1] 24136 0
Bangladesh
State/province [1] 24136 0

Funding & Sponsors
Funding source category [1] 309661 0
University
Name [1] 309661 0
Bangabandhu Sheikh Mujib Medical University (BSMMU)
Country [1] 309661 0
Bangladesh
Primary sponsor type
University
Name
Bangabandhu Sheikh Mujib Medical University (BSMMU)
Address
Kazi Nazrul Islam Avenue, Dhaka-1000.
Country
Bangladesh
Secondary sponsor category [1] 310679 0
Hospital
Name [1] 310679 0
Bangabandhu Sheikh Mujib Medical University Hospital
Address [1] 310679 0
Kazi Nazrul Islam Avenue, Dhaka-1000.
Country [1] 310679 0
Bangladesh

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309428 0
Institutional Review Board, Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbagh, Dhaka-1000.
Ethics committee address [1] 309428 0
Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbagh, Dhaka-1000.
Ethics committee country [1] 309428 0
Bangladesh
Date submitted for ethics approval [1] 309428 0
10/09/2020
Approval date [1] 309428 0
07/11/2020
Ethics approval number [1] 309428 0
N0-BSMMU/2020/9708

Summary
Brief summary
With a view to improve breathing difficulty of COVID-19 infected patients this study will be conducted in BSMMU Hospital, Dhaka. A total of 100 patients with COVID-19 will included for the study. Inclusion of the subjects will be confirmed by laboratory findings. Subjects will be selected for the study according to the specific inclusion and exclusion criteria. Informed consent will be taken properly. Patients will be provided breathing exercise along with standard treatment in one group and another one group will be provided standard treatment only. Randomization of the patients into two groups will be done by the way of lottery. Breathing exercise procedure will be given by a trained Physiotherapist under the supervision of a Physiatrist. Exercise will be given daily for four weeks. Follow up will be done weekly for four weeks also. The gathered data will be analyzed statistically. Both paired and unpaired Student’s ‘t’ test and Chi-squired test will be done as applicable. By the present study, the breathing capacity of the patient may be increased and ultimately complication in the lungs may be decreased.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114130 0
Prof Md Abdus Shakoor
Address 114130 0
Room-02, Block-B, Department of Physical Medicine and Rehabilitation, Bangabandhu Sheikh Mujib Medical University, Shahbagh, Dhaka -1000
Country 114130 0
Bangladesh
Phone 114130 0
+88 01819410080
Fax 114130 0
Nil
Email 114130 0
[email protected]
Contact person for public queries
Name 114131 0
Prof Md Abdus Shakoor
Address 114131 0
Room-02, Block-B, Department of Physical Medicine and Rehabilitation, Bangabandhu Sheikh Mujib Medical University, Shahbagh, Dhaka -1000
Country 114131 0
Bangladesh
Phone 114131 0
+88 01819410080
Fax 114131 0
Nil
Email 114131 0
[email protected]
Contact person for scientific queries
Name 114132 0
Prof Md Abdus Shakoor
Address 114132 0
Room-02, Block-B, Department of Physical Medicine and Rehabilitation, Bangabandhu Sheikh Mujib Medical University, Shahbagh, Dhaka -1000
Country 114132 0
Bangladesh
Phone 114132 0
+88 01819410080
Fax 114132 0
Nil
Email 114132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 382768-(Uploaded-12-02-2023-16-10-03)-Basic results summary.docx
Plain language summaryNo A total of 110 patients were included in the trial... [More Details]

Documents added automatically
No additional documents have been identified.