Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001108808
Ethics application status
Approved
Date submitted
6/08/2021
Date registered
20/08/2021
Date last updated
28/10/2021
Date data sharing statement initially provided
20/08/2021
Date results information initially provided
28/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Respiratory Rehabilitation on the Patients with COVID-19 infection.
Scientific title
Effects of Pulmonary Rehabilitation on the Patients with COVID-19 infection.
Secondary ID [1] 304981 0
NIL
Universal Trial Number (UTN)
NA
Trial acronym
PRPC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breathing difficulty 323136 0
COVID-19 323137 0
Other respiratory tract infection 323169 0
Condition category
Condition code
Respiratory 320754 320754 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pulmonary rehabilitation: Pulmonary rehabilitation will be provided as intervention along with standard treatment, and it will be given by the same Physiotherapist under direct supervision of a Physiatrist properly. Pulmonary rehabilitation will be delivered daily for 4 weeks, each session is anticipated to take 15 minutes to complete. And a Bangla written pulmonary rehabilitation procedure 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. Pulmonary rehabilitation is as follows: 1. Prone positioning, 2. Chest Physical therapy: Positioning>cupping>vibration>suction and
Ventilator muscle strength training and 3.Breathing exercises. 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] 321400 0
Treatment: Other
Comparator / control treatment
Control group will be provided standard treatment for COVID-19 as per WHO guideline according to the severity of the disease. Standard treatment will be given according to the symptoms of the patients which include oxygen therapy, paracetamol, antihistamine, heparin, steroid, antibiotic as necessary according to the need of the patients and as prescribed by the concerned physicians.
Control group
Active

Outcomes
Primary outcome [1] 328550 0
Breathing difficulty will be assessed by using Modified Medical Research Council (MMRC) scale.
Timepoint [1] 328550 0
At week one with week 2, 3 and 4 (post-enrolment)
Primary outcome [2] 328565 0
Modified Borg Scale (MBS) to determine the breathing difficulty after exercise
Timepoint [2] 328565 0
Weekly for four weeks post-enrolment
Secondary outcome [1] 399403 0
Respiratory rate per minute: It will be estimated by counting the inspiration and expiration per minute
Timepoint [1] 399403 0
At weeks 1, 2, 3 and at the end of follow up period i.e. at 4th week.( post -treatment)

Eligibility
Key inclusion criteria
• Nasopharyngeal swab samples (tested by RT-PCR) positive for the novel coronavirus.
• Subjects Aged 15 years or more of all genders.
• Oxygen 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 understand the content of questionnaires and who will provide informed 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.
• Pregnant woman will be excluded from the study.

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 is not 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 lottery will be done.
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
All data will be expressed as frequency, percentage and mean ± standard deviation (SD). Both student’s ‘t’ test and Chi-square test ( as required) will be used to compare differences between different variables. P value < 0.05 will be considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2020
Date of last participant enrolment
Anticipated
30/08/2021
Actual
31/08/2021
Date of last data collection
Anticipated
31/08/2021
Actual
31/08/2021
Sample size
Target
155
Accrual to date
Final
155
Recruitment outside Australia
Country [1] 24032 0
Bangladesh
State/province [1] 24032 0

Funding & Sponsors
Funding source category [1] 309368 0
Government body
Name [1] 309368 0
Bangladesh Medical Research Council
Country [1] 309368 0
Bangladesh
Primary sponsor type
Government body
Name
BANGLADESH MEDICAL RESEARCH COUNCIL
Address
BANGLADESH MEDICAL RESEARCH COUNCIL
MOHAKHALI, DHAKA-1212, BANGLADESH
Country
Bangladesh
Secondary sponsor category [1] 310339 0
Hospital
Name [1] 310339 0
Bangabandhu Sheikh Mujib Medical University
Address [1] 310339 0
Shabagh, Dhaka- 1000
Bangladesh
Country [1] 310339 0
Bangladesh
Secondary sponsor category [2] 310406 0
Hospital
Name [2] 310406 0
BSM Medical University
Address [2] 310406 0
Shabagh, Dhaka,
Country [2] 310406 0
Bangladesh

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309185 0
Ethics Review committee of Bangladesh Medical Research Council
Ethics committee address [1] 309185 0
BANGLADESH MEDICAL RESEARCH COUNCIL
MOHAKHALI, DHAKA-1212, BANGLADESH
Ethics committee country [1] 309185 0
Bangladesh
Date submitted for ethics approval [1] 309185 0
Approval date [1] 309185 0
29/06/2020
Ethics approval number [1] 309185 0
Ref: BNRC/ Revenue-Grant/2019-2020/753 (1-31)

Summary
Brief summary
In a view to improve pulmonary functions this study will be conducted in the Fever clinic, BSMMU and Kurmitola General Hospital, Dhaka. A total of 155 patients with COVID-19 will included in this study. Study population will be confirmed by laboratory findings. Patients will be selected for the study by specific inclusion and exclusion criteria. Informed consent will be taken properly. Patients will be provided pulmonary rehabilitation treatment 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. Pulmonary rehabilitation procedure will be given by a trained Physiotherapist under the supervision of a Physiatrist. Rehabilitation treatment will be given daily for four weeks. Follow up of the patient will be done weekly. The gathered data will be analyzed statistically. Both paired and unpaired Student’s ‘t’ test and Chi-squired test will be done as required. By this study, the respiratory capacity of the patient can be increased and ultimately lung complication may be reduced.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113266 0
Prof Md Abdus Shakoor
Address 113266 0
Room-02, Block-B, Department of Physical Medicine and Rehabilitation, Bangabandhu Sheikh Mujib Medical University, Shahbagh, Dhaka -1000
Country 113266 0
Bangladesh
Phone 113266 0
+8801819410080
Fax 113266 0
Nil
Email 113266 0
[email protected]
Contact person for public queries
Name 113267 0
Prof Md Abdus Shakoor
Address 113267 0
Room-02, Block-B, Department of Physical Medicine and Rehabilitation, Bangabandhu Sheikh Mujib Medical University, Shahbagh, Dhaka -1000
Country 113267 0
Bangladesh
Phone 113267 0
+880 1819410080
Fax 113267 0
Email 113267 0
[email protected]
Contact person for scientific queries
Name 113268 0
Prof Md Abdus Shakoor
Address 113268 0
Room-02, Block-B, Department of Physical Medicine and Rehabilitation, Bangabandhu Sheikh Mujib Medical University, Shahbagh, Dhaka -1000
Country 113268 0
Bangladesh
Phone 113268 0
+8801819410080
Fax 113268 0
Nil
Email 113268 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 382552-(Uploaded-24-10-2021-17-18-03)-Basic results summary.docx
Plain language summaryNo A total of 155 patients were included for the stud... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of Pulmonary Rehabilitation on the Patients with COVID-19 infection.2023https://dx.doi.org/10.3329/bmrcb.v49i1.62922
N.B. These documents automatically identified may not have been verified by the study sponsor.