| CTRI Number |
CTRI/2024/10/075509 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Design and development of a mobile application to identify sarcopenia in older adults |
|
Scientific Title of Study
|
Design and Development of an mHealth application for the detection of Sarcopenia in older adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meghna Prabhu |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Health Professions, MAHE Manipal |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9769696407 |
| Fax |
|
| Email |
meghna1.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish N |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions, MAHE Manipal |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886782114 |
| Fax |
|
| Email |
girish.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Girish N |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions, MAHE Manipal |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886782114 |
| Fax |
|
| Email |
girish.n@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room No 01. Department of Physiotherapy. Manipal College of Health Professions, MAHE Manipal 576104 |
|
|
Primary Sponsor
|
| Name |
Meghna Prabhu |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE Manipal |
| 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 |
| Dr Girish N |
Manipal College of Health Professions |
Room No 01, Department of Physiotherapy, Manipal College of Health Professions, MAHE Manipal, India,576104
Udupi
KARNATAKA |
9886782114
girish.n@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Phase 2 & 3- Inclusion criteria: a) Either gender b) Age- 60-90 years c) Mini-Cog score of more than 3
Phase 3; Step 2- For usability evaluation- Inclusion Criteria- Minimum 1-year experience with geriatric patients affiliated with MAHE from the Departments of Nursing, Occupational Therapy, Physiotherapy, Medicine, and Community Medicine. |
|
| ExclusionCriteria |
| Details |
Phase 2 & 3- Exclusion: a) Bed-ridden b) Any recent event that caused immobility for the past 3 months c) Critically or terminally ill/ Active infection (Respiratory; blood); Bed-bound /Wheelchair-bound; Acute onset (less than 30 days) of cardiorespiratory/orthopedic/neurological/ renal disease d) Chronic medical condition
that contra-indicates physical performance evaluation like (conditions not limited to) Stroke, Parkinson’s, Multiple Sclerosis, Chronic heart failure, Dementia or Alzheimer’s Disease, Peripheral neuropathies etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of surrogate measures of muscle strength, muscle mass, and physical performance through literature review and expert consensus regarding the measures that can be incorporated in the application |
Since this is a cross-sectional study, all outcome measures will be assessed at one time i.e. at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of the application with the surrogate measures incorporated and determine its validity |
8 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/12/2024 |
| 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="3"
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
|
Sarcopenia is a progressive condition characterized by loss of muscle strength, muscle mass, and low physical performance. The diagnostic criteria involve the use of expensive equipment, which leads to under-diagnosis in resource-limited settings. Hence, we aim to develop an application that can be used in multiple settings. Phase 1 of the study includes identifying the surrogate measures followed by expert content validation to identify the relevant measures to be included in the application. In Phase 2, we develop the application and determine its concurrent validity. In Phase 3, we assess its diagnostic accuracy and usability, and a final version of the application will be released. |