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CTRI Number  CTRI/2024/01/061987 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 11/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Physiotherapy for Post-COVID-19 Conditions 
Scientific Title of Study   Comparing Effectiveness of Physiotherapy versus Drug Management on Fatigue, Physical Functioning, and Episodic Disability for Myalgic Encephalomyelitis in Post-COVID-19 Condition 
Trial Acronym  PCCPT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Altaf Hossain Sarker 
Designation  Professor 
Affiliation  Jashore University of Science and Technology (JUST) 
Address  Room No 302, Department of Physiotherapy and Rehabilitation, M R Khan Medical Center, Jashore University of Science and Technology, Jashore-7408, Bangladesh



7408
Other 
Phone  8801571297407  
Fax    
Email  altafhossainsarker272@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Iqbal Kabir Jahid 
Designation  Professor 
Affiliation  Jashore University of Science and Technology 
Address  Department of Microbiology, Jashore University of Science and Technology (JUST) Jashore Bangladesh



7408
Other 
Phone  8801709818178  
Fax    
Email  ikjahid_mb@just.edu.bd  
 
Details of Contact Person
Public Query  
Name  K M Amran Hossain 
Designation  Lecturer 
Affiliation  Jashore University of Science and Technology 
Address  Room No 302, Department of Physiotherapy and Rehabilitation, M R Khan Medical Center, Jashore University of Science and Technology, Jashore-7408, Bangladesh



7408
Other 
Phone  01778790798  
Fax    
Email  kma.hossain@just.edu.bd  
 
Source of Monetary or Material Support  
Physiotherapy unit, BRB Hospitals Ltd, Panthapath, Dhaka-1205, Bangladesh 
 
Primary Sponsor  
Name  Jashore University of Science and Technology 
Address  Jashore University of Science and Technology Jashore-7408 Bangladesh 
Type of Sponsor  Government funding agency 
 
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 
Dr Tofajjal Hossain  BRB Hospital Limited and Specialized Physiotherapy Hospital Ltd  Room No 202, Department of Physiotherapy, BRB Hospital Limited,77A Panthapath, Dhaka 1215, Bangladesh

 		 01715560669

yousufraju6423@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Physiotherapy, Rehabilitation & Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J984||Other disorders of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adapted physical activity and therapeutic exercise through telemedicine (APTE-T)  3 Months. APTE-T the interventions will be provided by a consultant physiotherapist through digital media Such as Zoom, WhatsApp, Facebook Messenger, or the personalized app of the Department of Physiotherapy and Rehabilitation at Jashore University of Science and Technology. It will be a 45-minute session with a one-to-one approach. The patient will be performing exercises or advice at home. The physiotherapist will explain and demonstrate procedures through cameras, and the patient will perform. There will be continuous communication with the patients to ensure that the interventions provided are performed accordingly and is safe. 
Comparator Agent  Drug Management (DM)  3 Months. Participants of the drug management group will receive the drug interventions as azithromycin, remdesivir, favipiravir, infliximab, tocilizumab, siltuximab, hydrocortisone, rituximab, rintatolimod, intravenous immunoglobulin [15, 16]. The drug interventions will be directly prescribed by a physician specialized in treating PCC cases. A single brand name will be prescribed for each drug. We will communicate with the patients to ensure no adverse effects of the medications. The patient will be given a choice if they are willing to join the exercise programs; they have full liberty to join the programs even after the completion of the trial. 
Intervention  Institute-based adapted physical activity and therapeutic exercise (APTE-I)  3 Months. APTE-I will be provided under the consultation of a consultant physiotherapist specializing in Post-COVID-19 Condition rehabilitation. Interventions will be provided for 45-minute sessions in a one-to-one approach. There might be some home exercises or advice to follow at home. There will be continuous communication with patients. To ensure that the treatment does not deteriorate the symptoms. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Diagnosis of long COVID according to who working group criteria1, 2) Diagnosis of chronic fatigue syndrome(CFS) according to the 2006 Canadian consensus criteria5, 3) Respondents meeting with persistent or relapsing chronic fatigue and post exertion malaise or fatigue criteria of the Canadian consensus guideline, and 4) willing to participate with the trail with a consent of adherence with the intervention 
 
ExclusionCriteria 
Details  (1) any preexisting post-exertion symptoms exaggeration, (2) any preexisting clinical condition with fatigue as cardiovascular or neurological disability, (3) any red flags or signs that are explained as contraindication according to safe Post-COVID-19 condition rehabilitation guideline, and (4) patient drop-out within the 1st week of inclusion 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Chalder fatigue Scale (CFS)  At baseline, 12 weeks and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Physical Functioning sub-domain of SF-36  At baseline, 12 weeks and 6 months 
Disability Adjacent Life Years (DALYs)  At baseline, 12 weeks and 6 months 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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   Phase 4 
Date of First Enrollment (India)   10/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/05/2024 
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)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [altafhossainsarker272@gmail.com].

  6. For how long will this data be available start date provided 31-05-2024 and end date provided 31-12-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   ME/CFS patients will be recruited and treated in three specialized Hospitals. The study will be conducted in BRB Hospital Limited and Specialized Physiotherapy Hospital Ltd in the Dhaka division. In the Khulna division, the treatment center will be the Department of Physiotherapy and Rehabilitation at Jashore University of Science and Technology. The APTE-I, APTE-T, and DM groups will be recruited from any centers. However, the DM group will have respondents from the participants who are not willing to take any exercise interventions and only accept to take drug management. To prevent cross-contamination of the data, different treatments set up will be arranged in each study setting, and separate personnel will be employed for each treatment group. 
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