| CTRI Number |
CTRI/2025/06/089216 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Frailty on Cognition
in elderly living in the Community |
|
Scientific Title of Study
|
Correlation of Frailty with Cognitive Impairment
in Community Dwelling Geriatric Subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anu Arora |
| Designation |
Professor |
| Affiliation |
School of Physiotherapy, D.Y.Patil Deemed to be University, Nerul |
| Address |
School of PT, DY Patil University,Sector 5 Nerul Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8452842895 |
| Fax |
|
| Email |
anu.arora@dypatil.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anu Arora |
| Designation |
Professor |
| Affiliation |
School of Physiotherapy, D.Y.Patil Deemed to be University, Nerul |
| Address |
School of PT,DYPatil University, Sector 5 Nerul Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8452842895 |
| Fax |
|
| Email |
anu.arora@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shraddha |
| Designation |
Physiotherapist |
| Affiliation |
School of Physiotherapy, D.Y.Patil Deemed to be University, Nerul |
| Address |
School of Physiotherapy, D.Y.Patil Hospital & Research Centre, Sector 5 nerul Navi Mumbai, India
Thane
MAHARASHTRA
400706
India |
| Phone |
08452842895 |
| Fax |
|
| Email |
wagleshraddha213@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
School of PT |
| Address |
School of PT
Sector 5 Nerul |
| 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 Anu Arora |
D.Y Patil Hospital & Research Centre |
Department of Physiotherapy, OPD No 26, DY.Patil Hospital & research Centre SECTOR 5 NERUL NAVI MUMBAI
Thane
MAHARASHTRA |
08452842895
anu.arora@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for Biomedical Health Research - D.Y. Patil Deemed to be University,School of Medicine,Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy geriatric subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Individuals who agree to give written informed consent for study.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1.Individuals who were morbid due to illness within the past 6 months.
2.Individuals with severe conditions having significantly impaired mobility. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Montreal Cognitive assessment (MoCA) scale |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frailty using Fried’s criteria |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/07/2025 |
| 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="0"
Months="6"
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
|
An increase in the level of frailty is characterized by reduced strength, endurance, and physiological function which may have a significant impact on cognition in elderly individuals. • Conversely, cognitive decline may contribute to functional deterioration and increase the risk of frailty, as elderly population with impaired cognition often struggle with daily living tasks, physical activity, and medication management, all of which can accelerate physical decline. • This bidirectional relationship suggests that frailty and cognitive impairment may not only co-exist but may also mutually reinforce each other, creating a vicious cycle of declining health in geriatric populations. • Hence, the purpose of this study was to assess the association between frailty and cognitive impairment in geriatric subjects. |