| CTRI Number |
CTRI/2024/07/071088 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) Other (Specify) [Otago Exercise Program and Yoga] |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Otago exercises and Yoga: Effects on Fall Risk, Walking Speed, and Quality of Life in Older Adults |
|
Scientific Title of Study
|
Effect of Otago Exercise Program Versus Yoga on risk of fall, gait speed and quality of life in young population: a randomized controlled 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 |
DrAnil Muragod |
| Designation |
Professor anf Head of Department of Geriatrics Physiotherapy |
| 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
590010
India
Belgaum KARNATAKA 590010 India |
| Phone |
08312473906 |
| Fax |
|
| Email |
anilmurgod@klekipt.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
DrAnil Muragod |
| Designation |
Professor anf Head of Department of Geriatrics Physiotherapy |
| 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
590010
India
Belgaum KARNATAKA 590010 India |
| Phone |
08312473906 |
| Fax |
|
| Email |
anilmurgod@klekipt.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Gawas Rutuja Namdeo |
| 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
590010
India
Belgaum KARNATAKA 590010 India |
| Phone |
9145036958 |
| Fax |
|
| Email |
rutujagawas95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Prabhakar Kore hospital and MRC. Belgaum KARNATAKA 590010 India |
| Shantai Vrudhashrama , Jamboti Road Bamanwadi, Kuttalawadi |
| Young old adukts residing in Belagavi city |
|
|
Primary Sponsor
|
| Name |
Self sponsored Project |
| Address |
Self sponsored Project |
| 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 |
| Rutuja Gawas |
Belagavi City |
Areas in Belagavi City
Karnataka Belgaum KARNATAKA |
9145036958
rutujagawas95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific and Ethics Committe, KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
mild to moderate risk of fall |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group- A
Otago Exercise Program |
Total: 30-minute sessions, 3 times a week for 4 weeks, including 5-minute warm-up and cool-down. Consisting of strengthening exercises, balance retraining exercises, and walking twice a week. |
| Comparator Agent |
Group- B
Yoga |
The session is for 30 minutes and occurs three times a week for four weeks. It will include a 5-minute warm-up, 20 minutes of Yogasana, and a 5-minute cooldown. Each asana is performed 5 times for 10 seconds. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
Young old elderly of either genders in the age group of 65-74 years.
➢ Participants who are able to follow the commands, who can ambulate with or without
walking aid for at least 3 meters.
➢ Participants with mild to moderate impairment of balance according to the Berg balance
scale with a score of 21-56 . |
|
| ExclusionCriteria |
| Details |
Reported injuries of the lower limb preceding 6 months, paresis, or any deformities in the
upper and lower limbs that might influence balance.
➢ Older adults who have had recent surgeries such as upper limb, spine, and lower limb
amputations and joint replacement surgery.
➢ Diagnosed severe cases of cardiovascular, respiratory, and psychological conditions.
➢ Elderly participants with diagnosed vestibular and neurological conditions like stroke,
Benign Paroxysmal Positional Vertigo, etc. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Risk of fall,
Gait Speed ,
|
baseline, at 2nd week and at 4th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
baseline, at 2nd week and at 4th week
|
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2024 |
| Date of Study Completion (India) |
01/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="9" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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)
|
The study will involve obtaining ethical clearance, recruiting participants, collecting demographic data, and assessing fall risk, gait speed, and quality of life. Participants will be divided into two groups: one receiving the Otago Exercise Program and the other receiving Yoga. The treatment will last 4 weeks, with readings taken at baseline, the 2nd week, and the 4th week. |