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
|
|
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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
General Public |
|
Intervention / Comparator Agent
|
|
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. |