| CTRI Number |
CTRI/2025/08/092472 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How poor appetite in older adults affects their physical abilities in long-term care homes. |
|
Scientific Title of Study
|
Relationship between anorexia of aging and physical performance among institutionalized older adults residing in long term care settings |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sivaraman Swaminatha Krishnasai |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Department of Physiotherapy Manipal college of health professions Manipal academy of higher education Udupi Karnataka India
Udupi
KARNATAKA
576104
India |
| Phone |
9490118458 |
| Fax |
|
| Email |
sivaraman.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish N |
| Designation |
Associate Professor |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Department of Physiotherapy Manipal college of health professions Manipal academy of higher education Udupi Karnataka India
Udupi
KARNATAKA
576104
India |
| Phone |
9886782114 |
| Fax |
|
| Email |
girish.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Navada |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Department of Physiotherapy Manipal college of health professions Manipal academy of higher education Udupi Karnataka India
Udupi
KARNATAKA
576104
India |
| Phone |
9886430431 |
| Fax |
|
| Email |
rajesh.gv@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy MCHP MAHE , Manipal , Udupi , Karnataka , India. 576104 |
|
|
Primary Sponsor
|
| Name |
Sivaraman Swaminatha Krishnasai |
| Address |
Department of Physiotherapy MCHP MAHE , Manipal , Udupi , Karnataka , India. 576104 |
| 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 Sivaraman Swaminatha Krishnasai pt |
Manipal College of health professions |
Department of Physiotherapy Manipal college of health professions Manipal academy of higher education Udupi Karnataka India
Udupi
KARNATAKA |
9490118458
sivaraman.mchpmpl2024@learner.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 - 2 ( student research ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Older adults aged 60 years and above |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1) Age more than or equal to 60 years
2) Any gender
3) Have enough vision to perform activities of daily living |
|
| ExclusionCriteria |
| Details |
1)Bed or wheelchair bound
2)Terminally ill
3)Cognitive impairments
4)Diagnosed psychiatric conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Simplified Appetite Nutritional Questionnaire |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Short Physical Performance battery |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
Final Enrollment numbers achieved (Total)= "85"
Final Enrollment numbers achieved (India)="85" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
17/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
To Look at the Relationship between Anorexia of aging and physical performance among older adults. A total 86 participants will be included based on the following eligibility criteria.
Inclusion criteria - Age more than or equal to 60 years. Any gender. Have enough vision to perform activities of daily living.
Exclusion criteria - Bed or wheelchair bound. Terminally ill. Cognitive impairments. Diagnosed psychiatric conditions.
It is an cross sectional study.Participants will be screened based on the eligibility criteria and those who fulfill the criteria and willing to participate in the study will be included. One-time assessment of Simplified appetite nutritional questionnaire and Short Physical Performance in older individual living in long-term care setting will be performed. Total study duration is 1 year.
|