| CTRI Number |
CTRI/2024/02/062806 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effect of exercises in weaker old people done at home in keeping them strong , mobile and balanced . |
|
Scientific Title of Study
|
The effect of Home-Based Otago Exercises in Maintaining the Mobility and
Muscle Strength in older adults with frailty |
| 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 Rashmi Sharma |
| Designation |
MPH final year student |
| Affiliation |
Indian Institute of Public Health-Delhi |
| Address |
Indian Institute of Public Health, Delhi
KIIT College Campus,
KIIT College of Engineering,
3rd Floor, Sohna Road - Mumbai Expressway,
Bhondsi Near Maruti Kunj,
Gurugram
Gurgaon HARYANA 122102 India |
| Phone |
8738855128 |
| Fax |
|
| Email |
drrashmi15@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aashna Mehta |
| Designation |
Associate Professor |
| Affiliation |
Indian Institute of Public Health(Delhi) |
| Address |
Indian Institute of Public Health, Delhi
KIIT College Campus,
KIIT College of Engineering,
3rd Floor, Sohna Road - Mumbai Expressway,
Bhondsi Near Maruti Kunj,
Gurugram
Gurgaon HARYANA 122102 India |
| Phone |
9871166674 |
| Fax |
|
| Email |
aashna.mehta@phfi.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Rashmi Sharma |
| Designation |
MPH final year student |
| Affiliation |
Indian Institute of Public Health(Delhi) |
| Address |
ndian Institute of Public Health, Delhi
KIIT College Campus,
KIIT College of Engineering,
3rd Floor, Sohna Road - Mumbai Expressway,
Bhondsi Near Maruti Kunj,
Gurugram
Gurgaon HARYANA 122102 India |
| Phone |
8738855128 |
| Fax |
|
| Email |
drrashmi15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Institue Of Public Health (Delhi), KIIT College Campus, KIIT College of Engineering, 3rd Floor, Sohna Road - Mumbai Expressway, Bhondsi Near Maruti Kunj, Gurugram HARYANA 122102 INDIA
|
|
|
Primary Sponsor
|
| Name |
Rashmi Sharma |
| Address |
Indian Institute of Public Health, Delhi
KIIT College Campus,
KIIT College of Engineering,
3rd Floor, Sohna Road - Mumbai Expressway,
Bhondsi Near Maruti Kunj,
Gurugram-122102, Haryana, India
|
| 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 Rashmi Sharma |
ECHS POLYCLINIC Delhi Cantt |
ROOM NO 1 (A),MEDICAL OPD ,General opd patients Exservicemen Contributary Health Scheme South West DELHI |
8738855128
drrashmi15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Indian Institute Of Public Health Delhi-Institutional Ethics Committee (IEC) |
No Objection Certificate |
| Indian Institute Of Public Health,DelhiInstitutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
frailty |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Behavioural intervention |
single-group quasi-experimental design will be implemented to assess the effect
of a 10-week home-based Otago exercises on frailty score, mobility, and muscle strength. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
60 years and older, male and females
Able to perform Timed up and go test
Independent for activity of daily living. |
|
| ExclusionCriteria |
| Details |
Severe cognitive impairment
Recent surgery (1 yr)
Using wheelchair for indoor use or unable to walk (3-meter walk)
Inflammatory arthritis
History of lower limb fractures
Neurological disorders affecting gait and balance
Any condition in which exercises are not recommended by treating physician |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The proportion of frailty among older veterans and their dependents attending polyclinic the
Fried Frailty Criteria.
• Change in mobility post-intervention using the Timed Up and Go test
• Change in muscle strength |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve the falling efficiency of older adult, help older adult overcome the fear of falling, and improve the subjective wellbeing of older adult. |
6 months ( twice follow up in between at 4 ,6 week) |
|
|
Target Sample Size
|
Total Sample Size="310" Sample Size from India="310"
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)
|
04/03/2024 |
| 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="0" Months="6" Days="10" |
|
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
|
Effect of Home-Based Otago Exercises in Maintaining the Mobility
and Muscle Strength in older adults with frailty Background: The Ex-Servicemen Contributory Health Scheme (ECHS)
has been providing healthcare to veterans since 2003. Frailty, a prevalent
issue among the elderly, hampers physical function, muscle strength, and
mobility. The Otago Exercise Program, known for its efficacy, offers a
promising solution for frail individuals. Rationale: Maintaining regular
physical activity is vital for elderly independence. Otago exercises, validated
and simple, have shown effectiveness in improving mobility and balance. The
home-based nature of these exercises makes them practical for elderly veterans
in ECHS helping in limited
understanding of Frailty in Veterans. Investigating the efficacy of Otago
exercises in the veteran population aligns with the goal of developing
sustainable and scalable healthcare solutions. Aim: This study aims about Effect of home-based Otago
exercises on mobility and muscle strength in 60 yrs. and older veterans and
their dependents within ECHS (Ex-Servicemen Contributory Health Scheme)
Polyclinic. Objectives: (a)To estimate the prevalence of frailty by baseline
mobility, muscle strength and frailty score in elderly population. (b) To see the effect of home-based Otago
exercises on mobility, muscle strength after 10 weeks. Methodology: Elderly veterans and their
dependents attending ECHS Polyclinic & Base Hospital will be recruited utilizing
exclusion -inclusion criteria and their willingness followed by a Quasi-experimental
design for pre and post assessments with Chair based Otago exercises. Sample
size Expecting the prevalence of
frailty in an Indian population as 24.9 %, the sample size at 95% confidence
levels, and 5% absolute precision was estimated as 288. Considering 10%
non-response, the sample size was estimated as 310. Exclusion and
Inclusion criteria applied. Frail subjects planned for Pretest baseline assessments
with frailty scores, questionnaire and Timed Up and Go test for mobility and
muscle strength. These frail veterans and their dependents will be assessed with
Fried Frail criteria, excluding pre-frail and robust individuals. A 10-week
home-based Otago exercise intervention will be implemented in these selected
frails, with baseline assessments of muscle strength and mobility score with
Timed Up and Go Time (TUGT). Proposed exercise programme will
be based on home-based Otago chair exercises. Planned for thrice follow up and finally will be reassessed for mobility, frailty, and
muscle strength to see for any change from baseline assessments
after 10 weeks. Ethical considerations include Institutional approval,
consent documentation, and participant confidentiality, Station Commander permission
to conduct study in ECHS Polyclinic. Expected Outcomes: Prevalence
of frailty,its predictors in veterans and their dependents with changes in
mobility ,muscle strength and frailty scores with chair based Otago exercise program planned for 10 weeks.
This proposal aims to contribute to the well-being of elderly veterans within
ECHS by addressing frailty through evidence-based home exercises, promoting
independence and overall health. Anticipated outcomes include validating Otago exercises for
mobility maintenance, potential application in diverse settings, and
integrating health monitoring. Study can recommend implementing Otago exercise
program (OEP) as a part of routine primary service provided for Elderly
population Reinforcement. Future plans involve replicating the study across
different geriatric cohorts, developing digitalized fall risk protocols, and
establishing nomograms for the Indian population. Replication in diverse
geriatric cohorts across the country. |