| CTRI Number |
CTRI/2025/03/083553 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of occupational therapy based functional mobility training in sarcopenia for healthy ageing |
|
Scientific Title of Study
|
Effect of Occupational Therapy based functional mobility training in sarcopenia for healthy aging |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arpit Dixit |
| Designation |
Masters in Occupational Therapy |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Occupational Therapy, Central Library, Jamia Hamdard, Hamdard Nagar, New Delhi
South
DELHI
110062
India |
| Phone |
9540948372 |
| Fax |
|
| Email |
mannudixit710@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Noor Mohammad |
| Designation |
Assistant professor |
| Affiliation |
Jamia Hamdard |
| Address |
5th Floor, Department of Occupational Therapy. Central library, Jamia Hamdard, hamdard nagar, new delhi
South
DELHI
110062
India |
| Phone |
9811745726 |
| Fax |
|
| Email |
noormohd@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Arpit Dixit |
| Designation |
Masters in Occupational Therapy |
| Affiliation |
Jamia Hamdard |
| Address |
5th Floor, Department of Occupational Therapy. Central library, Jamia Hamdard, hamdard nagar, new delhi
South
DELHI
110062
India |
| Phone |
9540948372 |
| Fax |
|
| Email |
mannudixit710@gmail.com |
|
|
Source of Monetary or Material Support
|
| 5th floor, occupational therapy department, central library, Jamia Hamdard, Mehrauli Badarpur Road, New Delhi, Delhi 110062 , India |
|
|
Primary Sponsor
|
| Name |
Arpit dixit |
| Address |
5th Floor, Department of Occupational Therapy. Central library, Jamia Hamdard, hamdard nagar, new delhi |
| 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 Noor Mohammad |
Jamia Hamdard |
room no. 11, occupational therapy unit, Rehabilitation center, Jamia Hamdard, Mehrauli Badarpur Road, New Delhi, Delhi 110062
South
DELHI |
9811745726
noormohd@jamiahamdard.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy individuals without any comorbidities |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Education and councelling |
The intervention consists of eight weeks protocol, consisting of 32 sessions. These sessions will be divided into 16 self-administered sessions and 16 supervised sessions.
protocol includes the following:
Brisk Walking, Deep Breathing Exercises, and Energy Conservation Techniques |
| Intervention |
Occupational Therapy based Functional Mobility Training |
The intervention consists of eight weeks protocol, consisting of 32 sessions. These sessions will be divided into 16 self-administered sessions and 16 supervised sessions.
protocol includes the following exercises:
Sit to stand
Stepping
Lunging
Reaching
Leg raising
Push-ups /wall push ups
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Participants with age above 60 years.
screened with sarcopenia with validated criteria. no participation in any other therapeutic intervention during the research period.
no medically necessary restrictions to perform exercises.
participants must not have experienced any unresolved injuries in six months preceding the study |
|
| ExclusionCriteria |
| Details |
individual with contraindications to exercises
Participants with any existing musculoskeletal, psychological, neurological condition and cognitive impairments.
Severe comorbidities (heart conditions, respiratory conditions)
Those currently undergoing other rehabilitation therapies |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
functional mobility
functional balance
core stability
quality of life
activity of daily living |
baseline and after 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mental health : depression, anxiety , stress scales 21 |
baseline and after 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Sarcopenia can significantly hinder the ability of older adults to perform daily living tasks and engage in social interactions, leading to isolation, and an increased risk of falls and associated injuries. Traditional exercise programs often fail to address the multifaceted nature of sarcopenia. By integrating occupational therapy based intervention that focuses on functional mobility, will provide a more comprehensive intervention that not only promotes physical strength but also enhances functional balance, ADL performance and quality of life. Understanding the potential benefits of occupational therapy -based interventions could lead to improved clinical practices and contribute to the development of effective strategies for supporting healthy aging in our increasingly aging population. HYPOTHESIS- Occupational therapy-based functional mobility interventions will significantly enhance core muscle strength and improve mobility in elderly individuals screened with sarcopenia |