| CTRI Number |
CTRI/2018/04/013341 [Registered on: 18/04/2018] Trial Registered Prospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Prediction of age related loss of muscle mass in older adults |
|
Scientific Title of Study
|
Develpment of a regression model for the prediction of sarcopenia among older adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tina Agnes |
| Designation |
Post graduate student |
| Affiliation |
School of Allied Health Sciences, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, School of Allied health Sciences
Udupi
KARNATAKA
576101
India |
| Phone |
9740688454 |
| Fax |
|
| Email |
tagnes877@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish N |
| Designation |
Associate professor |
| Affiliation |
School of Allied Health Sciences, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, School of Allied health Sciences
Udupi
KARNATAKA
576101
India |
| Phone |
9886782114 |
| Fax |
|
| Email |
girish.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Kavitha Vishal |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health Sciences, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, School of Allied health Sciences
Udupi
KARNATAKA
576101
India |
| Phone |
9986526077 |
| Fax |
|
| Email |
kavitha.vishal@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital,Madhav nagar, manipal, 576104 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Tina Agnes |
Manipal Academy of Higher Education |
Department of Physiotherapy, Out Patient Department, N1 and old age homes in and around udupi district
Udupi
KARNATAKA |
9740688454
tagnes877@gmail.com |
|
|
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
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sarcopenia |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Older adults more than or equal to 55 years of age
Either gender
Mini Mental State Examination score more than or equal to 24
Participants ambulating without assistance or assistive devices
|
|
| ExclusionCriteria |
| Details |
Participant contraindicated from performing the physical performance measures
End stage disease
Frail older adults.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Body Mass Index
SARC F score
|
Once |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/04/2018 |
| Date of Study Completion (India) |
29/01/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in the muscles ligaments and tendons journal Vol. 9 issue 3/2019 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study is a case-control study for the early detection and prediction of sarcopenia. Currently, the gold standard for diagnosing sarcopenia is DEXA scan but it is expensive and not available in most health care centers and not feasible to be used at a community level and physical performance measure are race or population specific hence there is a need to develop an easy and feasible prediction or risk stratification model. Permission was sought from Institutional research committee, School Of Allied Health Sciences, MAHE and Institutional Ethics committee, Kasturba Medical College and Kasturba Hospital, Manipal. Subjects were identified through camps, institutions and associations, they will be screened based on the inclusion criteria. Participant Information Sheet (PIS) was given and written Informed Consent(IC) was obtained. Participants were screened based on the inclusion criteria. The Individuals were screened for risk factors: Age, Gender, BMI, and history of smoking, history of alcoholism, physical inactivity, malnutrition, history of depression, History of diabetes mellitus type 2. Investigator conducted testing of grip strength using Jamar dynamometer and quadriceps strength using hand-held dynamometer and physical performance was measured by using 6-meter walk test and Short Physical Performance battery. Investigator administered SARC F questionnaire and measured the percentage of skeletal muscle mass using BIA and participants were classified into cases (sarcopenia) and controls (non-sarcopenic).
Binary logistic regression was used to determine the odds ratio and to develop the model. Level of significance was set at p ≤ 0.05. A regression model for the risk of sarcopenia was developed.
The regression model is Risk of sarcopenia= Exp [-0.193+0.405(age) -1.5549(BMI) +1.382 (physical activity) -1.882 (grip strength) -0.482 (quadriceps strength) - 5.399 (SPPB balance) + 1.56 ( SARC F score)] with a R square value of 0.72
|