| CTRI Number |
CTRI/2024/01/061778 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the relationship between hand grip strength and lower limb strength, fear of falling, and quality of life in the young elderly population. |
|
Scientific Title of Study
|
Correlation of hand grip strength with lower limb strength, fear of fall and quality of life in young old population : a cross sectional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAnil Muragod |
| Designation |
Professor anf Head of Department of Geriatrics Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy Center,Room No. 39, Sagar Floor, Dr.Prabhakar Kore Hospital and MRC.
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
08312473906 |
| Fax |
|
| Email |
anilmurgod@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnil Muragod |
| Designation |
Professor anf Head of Department of Geriatrics Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy centre,Room No. 39, Sagar Floor, KLE hospital
Dr.Prabhakar Kore Hospital and MRC.
Belgaum
KARNATAKA
590010
India
KARNATAKA
590010
India |
| Phone |
08312473906 |
| Fax |
|
| Email |
anilmurgod@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Gawas Rutuja Namdeo |
| Designation |
Post Graduate Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy centre,Room No. 39, Sagar Floor, KLE Hospital
Dr.Prabhakar Kore Hospital and MRC.
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9145036958 |
| Fax |
|
| Email |
rutujagawas95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Prabhakar Kore hospital and MRC.
Belgaum
KARNATAKA
590010
India |
| Young old adults residing in Belagavi city |
|
|
Primary Sponsor
|
| Name |
Self sponsored Project |
| Address |
Self sponsored Project |
| Type of Sponsor |
Other [Self sponsored ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Heeba Khan |
Sahyadri Nagar |
Sahyadri Nagar belagavi
Belgaum
KARNATAKA |
9341214177
heeba241999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific and Ethics Committe, KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
hand grip weakness, lower limb weakness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
Males and females who are of 60 and 69 years old and who can follow command and can walk independently or with any walking aid |
|
| ExclusionCriteria |
| Details |
Individuals who have reported injuries of lower limb preceding 6 months, paresis, or any deformities in Upper and lower limb that might influence balance, Individuals who have had recent surgeries such as upper limb, spine, and lower limb amputation, and joint replacement surgery.
Elderly individuals with vestibular and neurological conditions
Diagnosed cases of cardiovascular or respiratory conditions.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine correlation of hand grip strength with lower limb strength, fear of fall and quality of life in young old population. |
grip strength with lower limb strength, fear of fall and quality of life in young old population using Jamar hydralic dynamometer and push pull dynamometer |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/01/2024 |
| Date of Study Completion (India) |
29/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Study has been accepted for publication in Archives of Medicine and Health Sciences journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
| • Subjects will be screened according to the inclusion and exclusion criteria from the various areas from Belagavi city. • The Participants will be explained the purpose of the study and signed written informed consent will be obtained before participating in the study. Young old adults (60-69 years) will be recruited in the study. • Participants will be assessed for Handgrip strength using Jamar Hydraulic Hand dynamometer on the both upper limbs, Lower limb strength using Push-Pull dynamometer on the both lower limbs, Fear of Fall (FOF) by Fall efficacy scale International and Quality of Life (QOL) using Short Form -12 questionnaire (SF-12). • Participants will be alternatively assessed for Hand grip strength and lower limb strength for the both sides left and right alternatively with 1 minute break in between. • 3 readings will be taken and average of 3 readings will be calculated. | |