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CTRI Number  CTRI/2020/10/028179 [Registered on: 01/10/2020] Trial Registered Prospectively
Last Modified On: 11/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   An experimental study to find out the impact of post COVID physiotherapy and rehabilitation in Bangladesh 
Scientific Title of Study   Impact of Post COVID Physiotherapy and Rehabilitation in Bangladesh 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohammad Anwar Hossain 
Designation  Senior Consultant & Associate Professor, Head of Physiotherapy Department, 
Affiliation  Centre for the Rehabilitation of the Paralysed (CRP) 
Address  Department of Physiotherapy, CRP, Savar.
Department of Physiotherapy, CRP, Savar, Dhaka-1343


1343
Other 
Phone  01753559949  
Fax    
Email  anwar_physiobd@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Mohammad Anwar Hossain 
Designation  Senior Consultant & Associate Professor, Head of Physiotherapy Department 
Affiliation  Centre for the Rehabilitation of the Paralysed (CRP) 
Address  CRP, Chapain, Savar, Dhaka-1343
Department of Physiotherapy, CRP, Savar, Dhaka


1343
Other 
Phone  01753559949  
Fax    
Email  anwar_physiobd@yahoo.com  
 
Details of Contact Person
Public Query  
Name  KM Amran Hossain 
Designation  Lecturer 
Affiliation  Bangladesh Health Professions Institute (BHPI) 
Address  Bangladesh Health Professions Institute (BHPI), CRP, Savar, Dhaka-1343
MPT program, Department of Physiotherapy


1343
Other 
Phone  01735661492  
Fax    
Email  amranphysio@gmail.com  
 
Source of Monetary or Material Support  
Bangladesh Physiotherapy Association (BPA) 
Centre for the Rehabilitation of the Paralysed (CRP) 
 
Primary Sponsor  
Name  Mohammad Anwar Hossain 
Address  Department of Physiotherapy, CRP, Savar, Dhaka-1343 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Rubayet Shafin  Centre for the Rehabilitation of the Paralysed (CRP)  Department of Physiotherapy, CRP, Chapain, Savar, Dhaka-1343.

 		 01303292145

shafin.rubayet00@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
CRP Ethics Committee, Centre for the Rehabilitation of the Paralysed (CRP)  Approved 
The Institutional Review Board, Institute of Physiotherapy Rehabilitation and Research, BPA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Physiotherapy & rehabilitation intervention protocol  Experimental group-Ice packs, hot packs, general mobilization, Isometric exercises, Strengthening exercise, active assisted, resisted exercise, Positioning, Interval training exercise, aerobic exercises, active cycle breathing techniques, Buteyko breathing techniques, respiratory strengthening training exercise, and relaxation techniques Control group- General stretching exercise. Educational booklet group- An educational booklet 
Comparator Agent  Physiotherapy intervention, educational booklet  experimental group- a set of physiotherapy interventions once in week for 6 weeks. Educational booklet group: An educational booklet containing home exercise protocol, patient education.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients who will be diagnosed COVID-19 positive by RT-PCR test.
2.The age range will be above 18 years because usually affected COVID-19 in elderly age and younger age people will affect but not more susceptible.
3.Male and female will be same prioritized although more male is more at risk
4.People who are willing to participate.
 
 
ExclusionCriteria 
Details  1.Patients who will be the severe physical illness that they are unable to communicate with others.
2.Patients who are below 18 years old.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study will be the pain types and severity, muscle strength, cardio-respiratory functioning between the (3) three groups. Pain types and severity will be measured by the Mcgill pain questionnaire and modified Orebro musculoskeletal index. Muscle strength of the upper limb and lower limb will be measured by hand dynamometer and modified hand dynamometer. The cardio-respiratory function will be measured by six minutes walk test, spirometry.   baseline data pain types, severity, functional status, cardiorespiratory functional status will be collected at first. then after 4 session, post intervention data will be collected. It will take 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome of this study will be functional status, coping strategy, and quality of life of COVID-19 survivors. The functional status will be measured by Post-COVID functional status. The coping strategy will be measured by Brief-coping questionnaire. Quality of life will be measured by the WHO-QoL-brief questionnaire.   Completing 4 session of physiotherapy intervention and final data collection, after 2 months follow up data will be collected to measure secondary outcome.  
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="0" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/10/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Title: Impact of Post COVID Physiotherapy and Rehabilitation in Bangladesh

Aims and Objectives

Aim: Aim of this study will be to figure out the impact of physiotherapy & rehabilitation among post-COVID patients.

Objectives:

·         To find out the musculoskeletal, neurological, cardiovascular, and respiratory status of the COVID-19 survivors after pre and post-COVID physiotherapy & rehabilitation.

·         To evaluate the high-level mobility status among the COVID survivors after pre and post physiotherapy & rehabilitation.  

·         Assess the quality of life of the COVID survivors before and after the Post COVID Physiotherapy rehabilitation.

·         To know the coping strategy to cope with the current situation has been taken by the COVID survivors and coping status after pre and post-COVID physiotherapy & rehabilitation.

·         To find out the effectiveness of the educational booklet of post-COVID physiotherapy rehabilitation.

Hypothesis:

Null Hypothesis of this study:

Null Hypothesis 𝐻0 = 𝜇1 �’ 𝜇1 = 0 or 𝜇1 = 𝜇2, where the final mean difference is the same that will be meant the impact of Post COVID physiotherapy interventions are not significant upon the problems associated with functional barriers, quality of life.

Alternative Hypothesis of this Study:

Alternative Hypothesis 𝐻𝛼 = 𝜇1 �’ 𝜇1 ≠ 0 or 𝜇1 ≠ 𝜇2, where the final mean difference is not the same that will be meant the impact of Post COVID physiotherapy interventions are significant upon the problems associated with functional barriers, quality of life.

Study design: The study will be experimental. It study participants will be allocated into 3 groups. One the group will be the experimental group, another group will be an educational booklet group and the other group will be the control group.   

Study Population: Patients who will be previously diagnosed COVID-19 positive in RT-PCR test and recovered from COVID-19 positive status in Bangladesh.

Study area: COVID affected patients who will be residents in Bangladesh will be a targeted population in this study. So the whole of Bangladesh will be selected as the study area.

Sampling technique: The researcher will use a simple random sampling method to select samples as the sampling technique. Simple random sampling is a method used to cull a smaller sample size from a larger population and use it to research and make generalizations about the larger group.  The process is simple its ease of use and its accurate representation of the larger population. 

Outcome measurements tools 1.Self-structured Socio-demographic information. 2.COVID-19 exposure and symptoms related questionnaire. 3.Cardio-respiratory function information 4.Muscle strength information (will be measured by dynamometer). 5.Modified Barthel index 6.Modified High-level Mobility assessment tool 7.Self-administered Comorbidity Questionnaire 8.Post-COVID-19 Functional Status (PCFS) Scale 9.Brief-Coping scale 10.WHO Quality of Life questionnaire  (WHO QoL BREF) 11.The Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) 12.Mcgill Pain Questionnaire

Interventions

The whole study will be consists of (3) three groups. Experimental group, educational booklet group, and control group. The experimental group will be received physiotherapy rehabilitation interventions by trained physiotherapists. The educational booklet group will receive an educational booklet that will contain simple home exercise and activity advice supplied by the researcher. The Control group will receive no physiotherapy interventions.

This is an experimental study. Physiotherapy interventions will be categorized into three categories- Musculoskeletal, neurological, and cardio-respiratory. Physiotherapy interventions will be assessed and prescribe by different trained and qualified therapists. Baseline, post-test data, and follow-up data will be collected by the different data collectors.

a) Musculoskeletal problems- Participants who will complain about musculoskeletal problems after their recovery from COVID-19.  A major screening tool for a musculoskeletal problem is complaining about the pain by the participants. The secondary complaining is the loss of muscle strength. Interventions will be prescribed by different therapists according to the participant’s musculoskeletal complaint. For pain relieving pain, therapists will demonstrate pain-relieving techniques – Isometric exercises, Ice packs, hot packs, self-mobilization exercises. For loss of muscle strength, therapists will demonstrate strengthening exercises. Repetitions and frequency of the prescribed exercises will be chosen by therapists according to the necessity of the participant severity.

b) Neurological problems- Participants who will complain about neurological complain. Participants who will complain about generalized weakness, problems in balance during high mobility activity, muscle wasting, impaired hand dexterity, co-ordination problems will be considered in the neurology group. Active assisted, active exercise and resistance exercises will be used to improved coordination, balance, and functional capacity. Prescribed exercise frequency and intensity will be determined by therapists according to the participants’ complain.

c) Cardio-respiratory problems- Participants who will complain of cardio-respiratory problems will be included in this group. Participants who will complain shortness of breath, dyspnea, and Chest pain will be included in the cardio-respiratory group. Positioning, Interval training exercise, aerobic exercises, active cycle breathing techniques, Buteyko breathing techniques, respiratory strengthening training exercise, and relaxation techniques will be used to treat cardio-respiratory problems. Doses, frequency, and repetitions will be determined by physiotherapists. 

Intervention parameters Intervention parameter will be prescribed by Physiotherapy professionals. All three groups will receive at least and not more than 1 session per week. Participants from all groups will receive four (4) Physiotherapy sessions. The first session and final session will be home visiting. And between the first and final sessions, other sessions will be conducted by video counselling by the Physiotherapists. Usually, the time per session will be 20 to 30 minutes long.

Follow up After collecting the final data, follow-up data will be collected after 6 months. 

Data Collection Procedure

Data will be held by face to face interview or by video counselling of the COVID-19 survivors.  

Data analysis Data will be analyzed by SPSS 22 version and Microsoft Excel 13. The statistical test will select according to the nature of the Data. 

Data audit An external auditor will examine the data and all the data will keep at a data repository

 
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