| CTRI Number |
CTRI/2023/07/055583 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
24/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Muscle strength and functioning of lower limbs in older adults with diabetes |
|
Scientific Title of Study
|
Sarcopenia and lower limb functional status in frail older adults with 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 |
Pratheeksha Kamath |
| Designation |
Assistant Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Department of Geriatric Physiotherapy
2nd Floor
KLE INSTITUTE OF PHYSIOTHERAPY
Nehru Nagar Belagavi.
.Department of Geriatric Physiotherapy
2nd Floor
KLE INSTITUTE OF PHYSIOTHERAPY
Nehru Nagar Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
6362462770 |
| Fax |
|
| Email |
pratheekshakamath@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Yashashree D Bhide |
| Designation |
Intern |
| Affiliation |
KLE Institute Of Physiotherapy |
| Address |
2nd Floor
KLE INSTITUTE OF PHYSIOTHERAPY
Nehru Nagar Belagavi.
2nd Floor
KLE INSTITUTE OF PHYSIOTHERAPY
Nehru Nagar Belagavi.
Belgaum
KARNATAKA
591313
India |
| Phone |
8861357749 |
| Fax |
|
| Email |
yashibhide14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yashashree D Bhide |
| Designation |
Intern |
| Affiliation |
KLE Institute Of Physiotherapy |
| Address |
2nd Floor
KLE INSTITUTE OF PHYSIOTHERAPY
Nehru Nagar Belagavi.
2nd Floor
KLE INSTITUTE OF PHYSIOTHERAPY
Nehru Nagar Belagavi.
Belgaum
KARNATAKA
591313
India |
| Phone |
8861357749 |
| Fax |
|
| Email |
yashibhide14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Prabhakar kore Hospital
Nehru Nagar belagavi. |
|
|
Primary Sponsor
|
| Name |
Yashashree D. Bhide |
| Address |
Math galli sankeshwar, Belagavi
591313 |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Pratheeksha Kamath |
KLE Institute of Physiotherapy |
Geriatric department of KLE Institute of Physiotherapy 2nd floor room no.7 Belagavi
Belgaum
KARNATAKA |
6362462770
pratheekshakamath@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KLEU Institute of Physiotherapy Belagavi |
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
|
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with diabetes mellitus aged 65 years and above of both gender and willing to participate in the study.
Individuals with a score of 3 or more on Frailty Index For Elders(FIFE) |
|
| ExclusionCriteria |
| Details |
Individuals diagnosed with any neurological conditions.
Bed ridden patients.
Individuals with musculoskeletal deformity.
Individuals with cancer or under palliative care.
Diagnosed cases of cataract without corrective surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frailty Index For Elders(FIFE) |
ONCE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SARC F & SPPB |
ONCE |
|
|
Target Sample Size
|
Total Sample Size="175"
Sample Size from India="175"
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)
|
02/08/2023 |
| 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="23"
Months="8"
Days="3" |
|
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
|
- Ethical clearance will be obtained from the Institutional Ethical Committee on the proposed study
• All the participants will be screened based on the inclusion and exclusion criteria prior to their enrolment into the study. • The study purpose will be explained and all participants will be asked to sign a written informed consent form. • Individuals will be screened for diabetes, frailty using Frailty index for elders and for sarcopenia using SARC-F screening tool • Demographic data will be noted of all participants included in the study • Individuals who are considered as diabetic, frail and sarcopenic will be included in the study and will be administered using short physical performance battery for lower extremity functional status. • The data will be analyzed using SPSS Software. |