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CTRI Number  CTRI/2022/09/045689 [Registered on: 20/09/2022] Trial Registered Prospectively
Last Modified On: 06/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Moderate to vigorous physical activity in stroke risk population 
Scientific Title of Study   Effectiveness of Moderate to Vigorous Physical Activity among Stroke risk predicted population- A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shazia Neelam 
Designation  Research Scholar 
Affiliation  Chettinad Academy of Research and Education 
Address  Demo hall-13 department of physiotherapy, Chettinad Academy of Research and Education, Chettinad Health City Rajiv Gandhi Salai(OMR) Kelambakkam, Tamil Nadu.

Kancheepuram
TAMIL NADU
603103
India 
Phone  08668039598  
Fax    
Email  shzkhan73@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P Senthil 
Designation  Professor 
Affiliation  Chettinad Academy of Research and Education 
Address  College Block, 1st floor chettinad School of Physiotherapy, Chettinad Academy of Research and Education, Chettinad health city Rajiv Gandhi Salai(OMR) Kelambakkam, Tamil Nadu

Kancheepuram
TAMIL NADU
603103
India 
Phone  09841667912  
Fax    
Email  Senthil.p@care.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr P Senthil 
Designation  Professor 
Affiliation  Chettinad Academy of Research and Education 
Address  College Block 1st floor, chetinad school of pysiotherapy, Chettinad Academy of Research and Education,Chettinad health city Rajiv Gandhi Salai(OMR) Kelambakkam, Tamil Nadu

Kancheepuram
TAMIL NADU
603103
India 
Phone  09841667912  
Fax    
Email  Senthil.p@care.edu.in  
 
Source of Monetary or Material Support  
Chettinad Academy of research and Education,CARE 
 
Primary Sponsor  
Name  Chettinad Academy of Research and Education CARE 
Address  Chettinad Health city, Rajiv Gandhi Salai(OMR) Kelambakkam,Tamil Nadu 603103 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Shazia NeelamN  Chettinad Health City Rajiv Gandhi Salai(OMR) Kelambakkam Tamil Nadu 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shazia Neelam  Chettinad Hospital and Research Institute  Chettinad Academy of Research and Education (CARE), Chettinad school of physiotherapy, chettinad health city Rajiv Gandhi Salai(OMR) Kelambakkam Tamil Nadu
Kancheepuram
TAMIL NADU 		 8668039598

Shzkhan73@gmail.com 
shazia  Muthu Hospital  Outpatient Physiotherapy department Pulianthope High road, pattalam chennai
Chennai
TAMIL NADU 		 8668039598

shzkhan73@gmail.com 
Dr Sabiha Nikhat  S.A Poly Clinic  #24/1 perambur barracks road, pattalam Chennai
Chennai
TAMIL NADU 		 9789949907

mascot.nikki77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Human Ethics Committe for Students Research (IHEC-I),Chettinad Academy of Research and Education  Approved 
Muthu Hospital  Approved 
S.A. Poly clinic  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z77-Z99||Persons with potential health hazards related to family and personal history and certain conditions influencing health status,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  low impact aerobic exercise   low impact aerobic exercises along with lifestyle and behavioral modifications for 12 weeks 3 sessions per week for 60 minutes. 
Intervention  Moderate to Vigorous Physical Activity  Intervention includes physical activity being moderate and vigorous measured using heart rate variability. Exercise consists of aerobic, strengthening and balance exercises done for 12 weeks 3-5 sessions per week for 60 minutes. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age above 30 years
Both genders
Subjects who will be predicted with stroke risk score more than 6% in Stroke Riskometer tool.
Subjects willing to participate.
 
 
ExclusionCriteria 
Details  Previous stroke subjects
Subjects with musculoskeletal deformities
Subjects with epileptic cases
Subjects with other neurological diseases.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Systolic blood pressure, Hba1c, lipid profile, BMI.
 		 Baseline, at mid-term 6th week and at the end of 12th week.
 
 
Secondary Outcome  
Outcome  TimePoints 
Cooper’s Run test and International Physical Activity Questionnaire.
 		 Baseline, at mid-term 6th week and at the end of 12th week.
 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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 1/ Phase 2 
Date of First Enrollment (India)   22/09/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
�’Stroke is the second leading cause of death worldwide, and the leading cause of acquired disability in adults in most regions, countries of low and middle income have the largest burden of stroke accounting for more than 85% of stroke mortality worldwide.
�’In India it is the commonest cause of chronic adult disability. The lifetime risk of stroke after 55 years of age is 1 in 5 for women and 1 in 6 for men. Cardiovascular disease including stroke, which comprised 19% of death nationwide in the year 2001-2003 is estimated to rise to 36% by 2030.
�’The cumulative incidence of stroke ranged from 105 to 152/100000 persons per year and the crude prevalence of stroke ranged from 44.29 to 559/100000 persons in different parts of  India during the past decade.
�’Reducing the burden of stroke in the population requires identification of modifiable risk factors and demonstration of the efficacy of risk reduction efforts.

�’There are numerous risk factors for stroke which  are both modifiable (hypertension,smoking,diabetes,dyslipidemia, atrial fibrillation,obesity,sedentary lifestyle etc..) and non-modifiable factor(age,gender,family history,race).
�’Estimating stroke risk based on an individual’s particular combination of risk factors, particularly for a first stroke event, is an important component of primary care.
�’Inorder to reduce the stroke incidences it is highly important that the risk factors of stroke are reduced. There are Mass Approaches, target lifestyle modifications and target risk factor reduction programs, observational studies of moderate to vigorous physical activity shows reduction in stroke cases but there is no definite controlled trials performed yet to study the risk factor reduction.
�’Therefore this study on reducing risk factors of stroke by implying moderate to vigorous physical activity among stroke predicted population might be helpful for the society and create an insight for further research. 

 
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