| CTRI Number |
CTRI/2024/09/073806 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Tailored fitness for cognitive health: An experimental study |
|
Scientific Title of Study
|
Tailored bespoke exercises for mild cognitive impairment and early dementia in elderly-An
experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joann Johny |
| Designation |
Master of physiotherapy |
| Affiliation |
Yenepoya Physiotherapy college |
| Address |
MPT 2nd year classroom, MPT division, Physiotherapy department, Yenepoya physiotherapy college, Naringana, Derlakatte Mangalore Karnataka
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8075247346 |
| Fax |
|
| Email |
joannjohny1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R .SATHYARAJA |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya Physiotherapy college |
| Address |
Assistant professor room, Staff division , Physiotherapy department, Yenepoya Physiotherapy College ,Naringana, Derlakatte Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9150908049 |
| Fax |
|
| Email |
rsathyaraja@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
JOANN JOHNY |
| Designation |
Post graduate resident |
| Affiliation |
Yenepoya Physiotherapy college |
| Address |
MPT 2nd year classroom ,MPT Division , Physiotherapy department , Naringana, Yenepoya Physiotherapy college, Derlakatte, Mangalore
Yenepoya physiotherapy college, Derlakatte, Mangalore
Chitradurga
KARNATAKA
575018
India |
| Phone |
8075247346 |
| Fax |
|
| Email |
joannjohny1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self source ,Yenepoya Medical College Hospital(YMCH) |
|
|
Primary Sponsor
|
| Name |
Joann Johny |
| Address |
Yenepoya physiotherapy college, Naringana,Derlakatte, Mangalore-575018.Karnataka,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 |
| JOANN JOHNY |
OLAVINA HALLI REHABILITATION |
Olavina Halli -Rehabilitation and community development centre,Kinya post,Mangalore-575023
Uttara Kannada
KARNATAKA |
8075247346
joannjohny1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics committee 1 |
Approved |
| Yenepoya Ethics committee 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G328||Other specified degenerative disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cognitive exercises only |
Music therapy,colouring pictures,simple calculations,Dodging numbers,memorizing daily routine
Duration and frequency - 3 days per week for one hour |
| Intervention |
physical exercise and cognitive exercises |
Warm up exercises
strengthening exercises
Balance exercises
Aerobic exercises
Cognitive exercises like simple calculation ,Music therapy. Duration and frequency -3 days per week for one hour |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
60 years old or over with no hearing or visual dysfunction.
Able to understand the commands
ACE 3 score 70-76
MMSE score with 23 to 27 |
|
| ExclusionCriteria |
| Details |
Older adults who have serious physical disease
Severe weakness,
Long-term bed ridden
Those who had trouble completing the multi component exercise
training |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mini mental state examination
Short performance battery test |
Baseline,1st month, 2nd month and 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="1"
Months="0"
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
Modification(s)
|
This study aims to evaluate the effect of physical exercise in patients with mild cognitive impairment and early dementia to check whether there is improvement in cognition and physical strength as there is a decline in global cognition and decreased strength in geriatric population. It is mandatory to look after the consequences faced due to this impairment which may leads to severe morbidities. This study is an experimental study with sample size of 36, which are selected on the basis of inclusion and exclusion criteria and divided into two experimental groups, group 1 and group 2 where cognition exercises are given to both the groups and tailored bespoke exercise is given to group 2, 3 days per week for 1 hour. Here Addenbrooke’s cognitive examination (ACE 3) is used as a screening tool, Mini mental state examination (MMSE) as cognitive evaluation tool, Short physical performance battery (SPPB) for assessing physical function. The study outcome measures will be taking at baseline (prior the exercise), at 1st month, 2nd month and 3rd month of exercise. |