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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  
Name  Address 
nil  nil 
 
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  
Status 
Not Applicable 
 
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.

 
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