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CTRI Number  CTRI/2022/12/048197 [Registered on: 16/12/2022] Trial Registered Prospectively
Last Modified On: 10/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To study the connection of handgrip power in relation of body fat and blood pressure in the age of 30-70years 
Scientific Title of Study   to study the association between handgrip strength and obesity and hypertension in the age group of 30 to 70 years  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  V Sanjana 
Designation  Student 
Affiliation  Welcome Group School of Hotel Administration (WGSHA) 
Address  Welcome Group School of Hotel Administration (WGSHA) Manipal University of higher Education (MAHE) Manipal Udupi
Department of Dietetics and Applied nutrition room no 202 second floor WGSHA Manipal University of Higher Education Manipal
Udupi
KARNATAKA
576104
India 
Phone  6303658951  
Fax    
Email  vangapelli.sanjana@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Swathi Acharya K 
Designation  Assistant professor - senior scale 
Affiliation  Welcome Group School of Hotel Administration (WGSHA) 
Address  Welcome Group School of Hotel Administration (WGSHA), Manipal University of higher Education (MAHE), Manipal, Udupi.

Udupi
KARNATAKA
576104
India 
Phone  9535071393  
Fax    
Email  swathi.acharya@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Swathi Acharya K 
Designation  Assistant professor - senior scale 
Affiliation  Welcome Group School of Hotel Administration (WGSHA) 
Address  Welcome Group School of Hotel Administration (WGSHA), Manipal University of higher Education (MAHE), Manipal, Udupi.

Hassan
KARNATAKA
576104
India 
Phone  9535071393  
Fax    
Email  swathi.acharya@manipal.edu  
 
Source of Monetary or Material Support  
OPD waiting area, WGSHA  
 
Primary Sponsor  
Name  Sanjana v Navya Chandrika Sakshi Joshi 
Address  Welcome Group School of Hotel Administration (WGSHA) Manipal Udupi  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
V Sanjana  Manipal  Manipal
Udupi
KARNATAKA 
6303658951

vangapelli.sanjana@learner.manipal.edu 
V Sanjana  Udupi  Room no-203, Department of M.Sc. Dietetics and Applied Nutrition, WGSHA, Manipal
Udupi
KARNATAKA 
6303658951

vangapelli.sanjana@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
The Institutional Research Committee WGSHA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  General Public 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Individuals of age from 30 to 70 years.
Both males and females are included. 
 
ExclusionCriteria 
Details  Individuals with cancer, kidney disorders, on dialysis, and HIV.
Individuals with Hand surgeries, fractures, Hand paralysis, and loss of fingers. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Handgrip strength in the aging process in relation to obesity and Hypertension.  30days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="246"
Sample Size from India="246" 
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)   21/12/2022 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Yes 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Handgrip measurements can be one of the parameters for further studies in planning nutritional intervention
for managing obesity and hypertension. Muscle function is a dynamic indicator of muscle mass,
similar to body composition, which provides a qualitative component of nutritional status. Muscle
function assessment has gotten a lot of attention in recent years as a way to assess both functional
and nutritional conditions. Voluntary and involuntary muscle function can be measured using a
variety of techniques. In order to determine involuntary muscular contraction, electrical
stimulation at various frequencies with a constant isometric duration is used. It is the superior
procedure in terms of objectivity, but it is not appropriate for clinical routine. Handgrip strength is
a proven and most practical bedside method for measuring voluntary muscular strength (e.g.,
handgrip, knee extension, or hip flexion strength), making it appealing and the most commonly
used tool for clinical purposes.
The research gap is that there is a link between obesity and hypertension and handgrip strength
because few research studies claim that strong handgrip strength increases the risk of hypertension.
 
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