| CTRI Number |
CTRI/2024/12/077920 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to Compare upper extremity strength, endurance & function in older adults with & without diabetes mellitus. |
|
Scientific Title of Study
|
Comparison of upper quadrant anthropometric variables, muscle strength, muscle endurance & function in geriatric individuals with & without diabetes mellitus. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sabiha Begam |
| Designation |
MPT SCHOLAR |
| Affiliation |
MGM School of Physiotherapy, MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy, 2nd floor room no. 115 MGM Hospital, Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9854020990 |
| Fax |
|
| Email |
sabihasayyad@mgmsopnm.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Shetty PT |
| Designation |
Associate Professor |
| Affiliation |
MGM School of Physiotherapy, MGM Institute of Health Sciences, Kamothe, Navi Mumbai |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy, 2nd floor room no. 115 MGM Hospital, Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
mshetty@mgmsopnm.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Shetty PT |
| Designation |
Associate Professor |
| Affiliation |
MGM School of Physiotherapy, MGM Institute of Health Sciences, Kamothe, Navi Mumbai |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy, 2nd floor room no. 115 MGM Hospital, Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
mshetty@mgmsopnm.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy, 2nd floor room no. 115 MGM Hospital, Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel Raigad MAHARASHTRA 410209 India |
|
|
Primary Sponsor
|
| Name |
Sabiha Begam |
| Address |
MMGM School of Physiotherapy,
MGM Institute of Health Sciences, MGM Educational Campus Sector 1, plot no.1 and 2, Kamothe, Navi Mumbai 410209 Taluka Panvel District Raigad-
Maharashtra, India. |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Mamta Shetty PT |
MGM School of Physiotherapy MGM Institute of Health Sciences |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy, 2nd floor room no. 115 MGM Hospital, Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel Raigad MAHARASHTRA 410209 India
Raigarh
MAHARASHTRA |
02227437866
mshetty@mgmsopnm.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MGM College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
The study will include geriatric individuals aged ≥60 years diagnosed with diabetes mellitus for more than 10 years. Participants will be assessed based on HbA1c levels and matched with geriatric individuals without diabetes mellitus to ensure comparability.
|
|
| ExclusionCriteria |
| Details |
Individuals will be excluded from the study if they have cognitive impairments, a history of recent surgery or trauma within the past six months, or fractures of the upper quadrant. Additionally, those with musculoskeletal disorders affecting upper quadrant function, such as carpal tunnel syndrome, tendonitis, rotator cuff tear, frozen shoulder, osteoarthritis, rheumatoid arthritis, Dupuytrens contracture, or thoracic outlet syndrome, will be excluded. Furthermore, participants with diagnosed neurological disorders, including Alzheimer’s disease, Parkinson’s disease, epilepsy, multiple sclerosis, stroke, migraine, amyotrophic lateral sclerosis, Huntington’s disease, traumatic brain injury, or spinal cord injury, will not be eligible. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Muscle Strength-Hand Held Dynamometer
Muscle Endurance- Modified Pushup Test
Upper Extremity Functional Scale |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| upper extremity function |
baseline |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
28/01/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This trial aims to compare upper quadrant anthropometric variables, muscle strength, muscle endurance and functional capacity in geriatric individuals with and without diabetes mellitus. Given the impact of diabetes on the musculoskeletal system, including reduced muscle mass, strength, endurance and functional performance, this study investigates how diabetes exacerbates age-related physical decline in the upper body. The study addresses a gap in current research, as much literature has focused primarily on lower body complications in diabetic populations, with limited exploration of upper body function. By assessing upper quadrant body composition, muscle configuration and functional outcomes, this study seeks to identify differences between diabetic and non-diabetic elderly individuals. These findings could provide valuable reference data for designing targeted rehabilitation strategies and preventative approaches for enhancing quality of life and functional independence in older adults with diabetes. |