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Clinical Trial Details (PDF Generation Date :- Wed, 05 Jul 2023 16:49:36 GMT)

CTRI Number CTRI/2020/04/024408 [Registered on: 01/04/2020] - Trial Registered Prospectively

Last Modified On 31/03/2020
Post Graduate Thesis Yes
Type of Trial Interventional
Type of Study Physiotherapy (Not Including YOGA)
Study Design Non-randomized, Active Controlled Trial
Public Title of Study Weight reduction exercise programme in obesity individuals among school childrens
Scientific Title of "EFFECT OF LIFESTYLE MODIFICATIONS ON PHYSICAL AND PHYSCHOLOGICAL
Study BEHAVIOUR IN OVERWEIGHT CHILDREN"
Secondary IDs if Any Secondary ID Identifier
NIL NIL
Details of Principal Details of Principal Investigator
Investigator or overall
Name Malarvizhi D
Trial Coordinator
(multi-center study) Designation Professor
Affiliation SRM Institute of Science and technology
Address Dean Office SRM College of Physiotherapy SRM nagar,
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India
Phone 9840090522
Fax
Email malarvid@srmist.edu.in
Details Contact Details Contact Person (Scientific Query)
Person (Scientific
Name Sekar P
Query)
Designation Professor & Head
Affiliation SRM Institute of Science and technology
Address Department of Paediatrics SRM Medical College hospital and
research centre
Kancheepuram
TAMIL NADU
603203
India
Phone 9444003896
Fax
Email sekarpasupathy505@gmail.com
Details Contact Details Contact Person (Public Query)
Person (Public Query)
Name MALARVIZHI D
Designation Professor
Affiliation SRM Institute of Science and technology
Address Dean Office SRM College of Physiotherapy SRM nagar,
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India
Phone 9840090522

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 PDF of Trial
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Fax
Email malarvid@srmist.edu.in
Source of Monetary or Source of Monetary or Material Support
Material Support
> Malarvizhi D Professor SRM College of Physiotherapy SRM Institute of Science and Technology
SRM Nagar kattankulathur
Primary Sponsor Primary Sponsor Details
Name Malarvizhi D
Address SRM college of Physiotherapy
Type of Sponsor Other [independent study ]
Details of Secondary Name Address
Sponsor
NIL NIL
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
Suresh J Gurukulam School Room 202 Second 9698642928
Floor Department of
Physical Education suresh.jothi1986@gmai
Kancheepuram l.com
TAMIL NADU
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
Institutional Ethics Approved 23/08/2018 No
Committee
Regulatory Clearance Status Date
Status from DCGI
Not Applicable No Date Specified
Health Condition / Health Type Condition
Problems Studied
Healthy Human Volunteers obesity
Intervention / Type Name Details
Comparator Agent
Intervention Physiotherapy Exercises Moderate to vigorous activity -
60 minutes - balance between
resistance and aerobic exercise
for 8 months Fun activities, an
hour in duration, the end of
each week (Fun Fridays)
Awareness Health Educaton
Program
Comparator Agent Health Education Awareness Programme
Inclusion Criteria Inclusion Criteria
Age From 11.00 Year(s)
Age To 15.00 Year(s)
Gender Both
Details Childrens who are willing to participate in the study<br/> Children
with age group of 11-15<br/> BMI Z score equal to or greater than
the 85th percentile and below the 95th percentile<br/>
Exclusion Criteria Exclusion Criteria
Details Cardiac diseases

Respiratory diseases

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Congenital problems in upper or lower limb

Metabolic syndromes like Diabetes

Regular exercise
Method of Generating Other
Random Sequence
Method of Other
Concealment
Blinding/Masking Not Applicable
Primary Outcome Outcome Timepoints
1.Anthropometric parameters Pre and Post Test will be assessed
2.Cardiovascular endurance
3.Fat distribution
4.Physical performance

Secondary Outcome Outcome Timepoints

Academic Performance Pre and Post test will be assessed
Academic Performance
Target Sample Size Total Sample Size=138
Sample Size from India=138
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 09/04/2020
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=0
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Not Yet Recruiting
Trial (India)
Publication Details NIL
Brief Summary Effect of lifestyle modifications on Physical fitness and psychological behaviour in overweight
children. Subjects were selected based upon Inclusion and Exclusion criteria divided into two
groups experimental group and Control group, experimental group undergoing Physical Activity ,
Diet Modifications and active lifestyle interventions Control group Dietary Modifications , Active
Lifestyle Interventions outcome measures are Anthropometry characteristics, Six minute walk test ,
Results and conclusion revealed after completion study.

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