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CTRI Number  CTRI/2024/08/072860 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 17/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Prevention of Work related musculoskeletal disorder in desk employees 
Scientific Title of Study   Stretching exercise to prevent Work related musculoskeletal disorder (WMSD) in Desk employee: Cluster Randomized control trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Umesh Kawalkar 
Designation  Assistant Professor  
Affiliation  Government Medical College Akola 
Address  Department of Community Medicine
Government Medical College AKola
Akola
MAHARASHTRA
444001
India 
Phone  9730196442  
Fax    
Email  umeshkawalkar01@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Umesh Kawalkar 
Designation  Assistant Professor  
Affiliation  Government Medical College Akola 
Address  Department of Community Medicine
Government Medical College AKola
Akola
MAHARASHTRA
444001
India 
Phone  9730196442  
Fax    
Email  umeshkawalkar01@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Umesh Kawalkar 
Designation  Assistant Professor  
Affiliation  Government Medical College Akola 
Address  Department of Community Medicine
Government Medical College AKola
Akola
MAHARASHTRA
444001
India 
Phone  9730196442  
Fax    
Email  umeshkawalkar01@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College Akola Maharashtra India Pin:444001 
 
Primary Sponsor  
Name  Dr Umesh Kawalkar 
Address  Department of Community Medicine Government Medical College Akola, Maharashtra, India 444001  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Umesh Kawalkar   Government Medical College Akola Maharashtra India  Room no.2 , Department of Community Medicine Government Medical College Akola Maharashtra India
Akola
MAHARASHTRA 		 9730196442

umeshkawalkar01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intitutional Ethics Comitte Government medical college Akola   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  prevention of work related musculoskeletal disorder  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Manual-Only Group  Manual will be given to control arm  
Intervention  Stretch to Prevent: A Workplace WMSD Reduction Program  The intervention in this study involves the use of a developed manual of stretching exercises and nutrition guidelines, along with stretching exercise sessions led by a trained physiotherapist. The stretching exercise sessions will be conducted over a period of 6 months, with varying frequencies. Initially, the sessions will occur every 7 days, then transition to every 15 days, and finally, once a month. Each session will last for 20-30 minutes. In addition to the stretching exercises, there will be a nutrition advice session with an expert and a stress management lecture with a psychiatrist at specific points during the intervention period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All the desk employees and ready to participate in the study will be included. 
 
ExclusionCriteria 
Details  Security staff, Newly appointed staff less than six months
Medical conditions like heart disease ; spine disease or medical or surgical conditions contraindication for exercise  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Impact of stretching exercise intervention on work related musculoskeletal disorder (WMSD)  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Impact on Quality of work life   1 year
 
Impact on sickness absenteeism   1 year 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   01/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [umeshkawalkar01@gmail.com].

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 30-12-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

A cluster randomized control trial will be conducted to study the impact of a stretching exercise intervention on work-related musculoskeletal disorders (WMSD) in desk employees. The study will involve desk employees from both government and private sector offices. Participating offices will be randomized into intervention and control groups. The intervention group will receive a manual in the local language detailing stretching exercises and nutritional guidelines, along with stretching exercise sessions led by a trained physiotherapist. The control group will receive only the manual. The primary outcome will be the difference in WMSD incidence between the two groups after six months. Secondary outcomes will include the impact on quality of work life and sickness absenteeism. The study aims to assess approximately 400 desk employees.

 
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