| CTRI Number |
CTRI/2026/02/103691 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two exercise programs to improve memory, movement, sleep, and quality of life in older adults. |
|
Scientific Title of Study
|
Effect of Otago exercise vs Square stepping exercise on cognitive function, agility, sleep quality, and quality of life in elderly with mild cognitive impairment: A Randomized Clinical Trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Barsha Thapa |
| Designation |
post graduate student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy Center,Room No. 39, Sagar Floor,
Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA
590010 India Belgaum KARNATAKA
Belgaum KARNATAKA 590010 India |
| Phone |
7068552426 |
| Fax |
|
| Email |
barshat07@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Barsha Thapa |
| Designation |
post graduate student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy Center,Room No. 39, Sagar Floor,
Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA
590010 India Belgaum KARNATAKA
Belgaum KARNATAKA 590010 India |
| Phone |
7068552426 |
| Fax |
|
| Email |
barshat07@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anil Muragod |
| Designation |
Professor anf Head of Department of Geriatrics Physiotherapy |
| Affiliation |
KLE insttitute of Physiotherapy |
| Address |
Advanced physiotherapy Center,Room No. 39, Sagar Floor,
Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA
590010 India Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
590010
India
Belgaum KARNATAKA 590010 India |
| Phone |
08312473906 |
| Fax |
|
| Email |
anilmurgod@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Barsha Thapa |
| Address |
Advanced physiotherapy Center,Room No. 39, Sagar Floor,
Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA
590010 India Belgaum KARNATAKA 590010 India
Belgaum |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 Anil Muragod |
KLES Dr. Prabhakar Kohre Hospital and MRC, Nehru nagar, Belagavi 590010 |
Advanced physiotherapy Center,Room No. 39, Sagar Floor,
Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA
590010 India Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
590010
India Belgaum KARNATAKA |
08312473906
anilmurgod@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethics committee KAHER Institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
mild cognitive impairment in elderly |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
otago exercise |
3 times per week for 4 week |
| Comparator Agent |
square stepping exercise |
3 times per week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
Age from 60-69, elderly male and female in an old age home.
Mild cognitive impairment (MOCA: 18-25).
Able to ambulate independently or with assistive device for at least 200 meters.
Willing to participate in the study. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.MOCA( Montreal Cognitive Assessment) sacle.
2.8 foot up & go.
3.Pittsburgh sleep quality scale.
4. WHOQOL-BREF |
Base line and 4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2026 |
| 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="0" |
|
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
|
Balance impairment and decline in functional capacity increase significantly with age due to
physiological decline, including reduced muscle strength, proprioception, and mobility. [1,2]
Falls are a major global health problem among older adults, especially those living in nursing
homes, where more than one-third experience at least one fall annually.[2] Mild cognitive
impairment is a stage, between normal ageing and dementia, where an individual shows
memory and cognition issues but is nevertheless able to carry out daily chores.[3,4] The
prevalence of MCI varied by age category, ranging from 6%-25% for those aged 60 to 84.[3]
Dementia is more common in MCI patients over 65 who have had the condition for two
consecutive years.[3] Literature shows that physical exercise and cognitive training each
improve strength, balance, and cognitive performance, which produces greater benefits than
single interventions. In addition to improving brain and body function, exercise also promotes
brain plasticity, which can postpone cognitive decline, boost blood flow to the brain, and
activate nerve growth factors.[5] Previous studies consistently show that various forms of
exercise, including aerobic, resistance, mini-body, and multicomponent, can enhance overall
cognitive function and delay progression to dementia in older adults with mild cognitive
impairment. However, activities that require agility, balance, and coordination also improve
executive function, memory, and attention.[6]
• Otago originally developed in New Zealand, is an evidence-based- based intervention prove |