| CTRI Number |
CTRI/2024/10/076006 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [Otago exercise program, Pilates] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the Benefits of Otago Exercises and Pilates for Elderly People with Knee Pain |
|
Scientific Title of Study
|
Effect of otago exercise program versus pilates on pain strength balance and quality of life in elderly with knee osteoarthritis – 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 |
Dr Anil 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 |
Dr Anil 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
KARNATAKA
590010
India |
| Phone |
08312473906 |
| Fax |
|
| Email |
anilmurgod@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Heeba Khan |
| 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 |
9353530064 |
| Fax |
|
| Email |
heeba241999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Advanced physiotherapy centre,Room No. 39, Sagar Floor, KLE
Hospital Dr.Prabhakar Kore Hospital and MRC. Belgaum
KARNATAKA 590010 India
Belgaum
KARNATAKA |
|
|
Primary Sponsor
|
| Name |
HEEBA KHAN |
| Address |
OPD NO 39,SAGAR FLOOR,KLES DR.PRABHAKAR KORE HOSPITAL AND MEDICAL RESEARCH CENTRE,NEHRU NAGAR,BELAGAVI-590010,KARNATAKA,INDIA. |
| 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 |
| HEEBA KHAN |
KLES DR.PRABHAKAR KORE HOSPITAL & MRC. |
Advanced physiotherapy centre room no 39 sagar floor KLE hospital Dr. prabhakar kore hospital and MRC.belgaum KARNATAKA 590010 india
KARNATAKA
590010
India
Belgaum
KARNATAKA |
9353530064
heeba241999@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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 |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A ( Otago Exercise Program) |
Group A followed the Otago Exercise Program, including strengthening and balance training exercises, consisting of 40 minutes. Participants will also have walking sessions twice a week.
|
| Comparator Agent |
Group B (Pilates) |
It consists of a weekwise protocol for 40 minutes.
3 times a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
• Elderly males and females diagnosed with KOA.
• Age group of 60-75 years.
• According to Kellgren and Lawrence system for classification of osteoarthritis (grade 1-2) on X-ray findings.
• Subjects able to follow the commands , walk independently, with or without any walking aid.
• Subjects with mild impairment of balance according to berg balance scale with score (21-56).
• Subjects who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
• Subjects with open wounds ,active infection at the site ,bleeding disorders ,skin disease in and around knee joint.
• Reported injuries of upper limb and lower limb preceding 6 months .
• Paresis , or any deformities in Upper and lower limb that might influence balance.
• Elderly individuals with vestibular and neurological conditions like stroke , head injury.
• Individuals Diagnosed with severe cases of cardiovascular or respiratory conditions.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, Strength, Balance |
at baseline and at 4th week of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life |
at baseline and at 4th week of intervention |
|
|
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)
|
10/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
10/11/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
The study will be conducted after
obtaining Ethical clearance from the institutional ethical committee. Participants willing to participate will
be recruited according to inclusion and exclusion criteria and informed consent will be taken.
Participants will be briefed about the purpose of the study. Demographic data will be obtained from the recruited
participants and assessed
for Pain using The Numeric Rating Scale , strength using Push-Pull Dynamometer,
Balance using Berg Balance Scale and Quality of Life using TheWestern Ontario
and McMaster Universities Arthritis Index (WOMAC). The reading will be taken at
2 different times i.e. at baseline and at 4th week of the treatment.
The parameter will be entered in Excel and necessary statistical analysis will
be done. The participants will be divided into two
groups i.e. Group A (Otago Exercise Program) and Group B (Pilates), each
consisting of 24 participants. Group A will receive the Otago Exercise Program,
and Group B will receive Pilates, both for 40 minutes, 3 times a week for 4
weeks, with guidance from the principal investigator. |