| CTRI Number |
CTRI/2025/07/091182 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the Connection Between Posture-Related Blood Pressure Changes and Muscle mass among Older Adults Living in Long term Care Homes |
|
Scientific Title of Study
|
Relationship between orthostatic hypotension and muscle metrics among older adults 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 |
Deborah Liju Philip |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Health Professions, Manipal |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7738128241 |
| Fax |
|
| Email |
phil.debo08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish N |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions, Manipal |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886782114 |
| Fax |
|
| Email |
girish.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Miss Tina Agnes |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, Manipal |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9740688454 |
| Fax |
|
| Email |
tina.agnes@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
|
|
Primary Sponsor
|
| Name |
Deborah Liju Philip |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, 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 |
| Deborah Liju Philip |
Manipal College of Health Professions (MCHP) |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal- 576104
Udupi
KARNATAKA |
7738128241
phil.debo08@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 - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
older adults aged 55 and above |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Older adults aged 55 years or above, Either gender, Ability to follow commands and instructions, Enough vision to perform Activities of daily living, and Ability to stand unassisted |
|
| ExclusionCriteria |
| Details |
Critically ill/ Terminally ill, Cardiac pacemakers and metal implant, Foot injury, peripheral neuropathy, Any acute events (fever, acute illnesses) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Orthostatic hypotension |
In supine (baseline),
In standing (immediately) and
In standing (after 3 minutes)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hand Held Dynamometer,
Bioelectric impedance analysis (BIA) machine
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="85" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2025 |
| Date of Study Completion (India) |
22/12/2025 |
| 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 Applicable |
| 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
|
The purpose of the study is to find out the relationship
between orthostatic hypotension and muscle metrics among older adults residing
in long-term care settings. The study involves enrolling older adults aged 55
years and older, who will be required to provide informed consent. Residents of
the facility will be screened for eligibility. Orthostatic hypotension will be
evaluated using a digital sphygmomanometer. Before measuring blood pressure, the
participant will be asked to avoid consuming coffee or tea and will be
instructed not to engage in any exercise before the assessment. Skeletal
muscle mass will be assessed through a bioelectrical impedance analyzer, and
hand grip strength will be measured using a dynamometer. The evaluation will
take place consistently between 9:00 AM and 11:00 AM. After all outcome
measures will be recorded, the data collected will be analyzed. The total study
duration is 1 year. |