| CTRI Number |
CTRI/2025/08/092272 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of a Modified Otago Exercise Program on Balance and Well-being in Older Adults Living in the Community |
|
Scientific Title of Study
|
Effect of Modified - Otago Exercise Program on Balance and Quality of Life
in community- dwelling Older Adults with Impaired Balance - Pre post
Interventional 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 |
Prachi Thombare |
| Designation |
Post graduate student |
| Affiliation |
KJ Somaiya college of physiotherapy |
| Address |
KJ Somaiya college of physiotherapy ,Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, Maharashtra .
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7385592986 |
| Fax |
|
| Email |
prachithombare17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prachi Thombare |
| Designation |
Post graduate student |
| Affiliation |
KJ Somaiya college of physiotherapy |
| Address |
KJ Somaiya college of physiotherapy ,Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, Maharashtra .
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7385592986 |
| Fax |
|
| Email |
prachithombare17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tejal Pardeshi |
| Designation |
Guide and professor |
| Affiliation |
KJ Somaiya college of physiotherapy |
| Address |
KJ Somaiya college of physiotherapy ,Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9372668986 |
| Fax |
|
| Email |
tejal.pardeshi@somaiya.edu |
|
|
Source of Monetary or Material Support
|
| KJ Somaiya college of physiotherapy ,Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, Maharashtra. 400022 |
|
|
Primary Sponsor
|
| Name |
KJ Somaiya college of Physiotherapy |
| Address |
KJ Somaiya college of physiotherapy ,Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, Maharashtra. 400022 |
| Type of Sponsor |
Other [KJ Somaiya college of physiotherapy, Mumbai] |
|
|
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 Prachi Thombare |
KJ Somaiya college of Physiotherapy Mumbai |
Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, Maharashtra. Geriatric opd no.25 in community department
Mumbai
MAHARASHTRA |
07385592986
prachithombare17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Comittee KJ Somaiya college of physoo |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
normal physiological aging individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modified Otago Protocol for healthy older adults |
Description of Intervention:
Brief details of the components
A) Strength training - chair squats, tandem walking ,calf raises, wall push ups(12 repetitions,3sets)
B) Balance - one leg standing , side leg raises, spot marching, tandem stance( 30sec hold,3 set)
C)Aerobic exercise-Through FITT principle
Frequency- 3 times per week
Intensity- 50 % -70 % of HR max
Time- 10 mins
Type - walking
D)Stretching- neck stretch, shoulder stretch, hamstring stretch, calf stretch( 10 sec hold 3 sets)
Frequency (3 times a week).
Duration (for 6 weeks).
Delivery method ( supervised in-person sessions)
3. Mode of Delivery:
Physiotherapist-led sessions up.
4. Dosage/Intensity (if applicable):
12 repetitions, 45-minute sessions, progressively increasing intensity.
5. Duration and Schedule:
Participants will perform the Modified Otago Exercise Program 3 times per week for 6 weeks. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Community dwelling, asymptomatic older adults aged 60 to 80
years, of any gender, presenting with mild to moderate balance impairment
corresponding to Stages 3 and 4 of the Four-Stage Balance Test. Participants must be
ambulatory without the use of a walking aid, willing to participate in the study, and
must provide clearance through the Physical Activity Readiness Questionnaire
(PAR-Q+). |
|
| ExclusionCriteria |
| Details |
Diagnosed neurological disorders such as Parkinson’s disease or stroke
2. Severe cardiovascular conditions that may limit physical activity
3. Presence of a vestibular disorder
4. Severe cognitive impairment that may affect understanding or participation
5. Diabetic neuropathy
6. Uncorrected visual impairments affecting balance or mobility
7. History of falls within the past 6 months
8. Lower limb fractures or musculoskeletal conditions affecting mobility
9. Any medical condition contraindicating assessment with the Timed Up and
Go (TUG) test or participation in the intervention protocol
10. Severe balance impairment, defined as Stage 1 or 2 on the Four-Stage
Balance Test |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mini Best Test
The Indian Geriatrics Quality of Life Inventory Scale (IGQOLI) |
before starting intervention and at 3 and 6 th week of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
12/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
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 focuses on effect of modified Otago exercise program on balance and QOL in community dwelling older adults with impaired balance. As aging process brings about natural decline in physical abilities, with balance being one of the most significant factor contributing to falls among older adults.so the need of this study is driven by several factors such as prevalance of fall, lack of consensus .
so the modified Otago exercise program is a well known exercise Regieme designed to improve strength and balance , thereby reducing the incidences of fall. A sample size of 40 individuals will be taken.
All of them will be given modified Otago exercise program.
Outcome measures used are mini best test and Indian geriatric quality of life inventory scale which will be taken before giving intervention and at 3rd week and 6th week of intervention. |