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CTRI Number  CTRI/2023/07/054805 [Registered on: 05/07/2023] Trial Registered Prospectively
Last Modified On: 13/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectivness of core exercise training in patients diagnosed with knee osteoarthritis - A randomized controlled trial  
Scientific Title of Study   Effectiveness of Core Exercises On Knee Pain, Physical Function & Patient Reported Outcomes In Individuals Diagnosed With Knee Osteoarthritis - A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
IECKMCMLR05/2023/206  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tina Thomas Dias 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Mangalore, MAHE, India 
Address  Department of Physiotherapy Kasturba Medical College, Mangalore.

Dakshina Kannada
KARNATAKA
575004
India 
Phone  08310324823  
Fax    
Email  tina.mchpmlr2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Tina Thomas Dias 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Mangalore, MAHE, India 
Address  Department of Physiotherapy Kasturba Medical College, Mangalore.

Dakshina Kannada
KARNATAKA
575004
India 
Phone  08310324823  
Fax    
Email  tina.mchpmlr2022@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Charu Eapen  
Designation  Professor  
Affiliation  Kasturba Medical College, Mangalore, MAHE, India 
Address  Department of Physiotherapy Kasturba Medical College, Mangalore.

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9986024551  
Fax    
Email  charu.eapen@manipal.edu  
 
Source of Monetary or Material Support  
Department of physiotherpay,Room no 3, 2nd Floor, Kasturba Medical College and Hospitals, Attavar  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Tina Thomas Dias  Kasturba Medical College, Hospitals   Department of Physiotherpay 2nd Floor, Room no - 3 Kasturba Medical College, Hospitals, Attavar - 575001
Dakshina Kannada
KARNATAKA 		 8310324823

tina.mchpmlr2022@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituional Ethical Committee Kasturba Medical College Mangalore   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Knee Rehab  The comparator will be routine rehabilitation with quadriceps and hamstring muscle strengthening 
Intervention  Targetted Core exercise program   Core exercises targetting the Transverse abdominus and Multifidus as local muscles supporting the core , will be intervened  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients diagnosed with Kellgren Lawrence Grades 1- 3 of Knee OA 
 
ExclusionCriteria 
Details  Patients with severe knee OA, in whom knee replacement is indicated.
Patients with a history of hip OA, lower limb joint replacement, inflammatory arthritis, spine
surgery, lower limb surgery, or corticoid injection within the past three months.
Patients with a diagnosis of knee OA whose clinical evaluation by the physical therapist at
baseline was not consistent with knee OA based on age, history, and physical examination, or
those with a diagnosis of other conditions such as knee sprain 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual Analog Scale
Physical Function Test KOOS
30second sit to stand
40 m fast-paced walking test
Stair Climb Test
Timed Up & Go Test  		 The above mentioned outcome measures will be taken at Baseline 4 weeks 8 weeks & 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Muscle strength, X-ray , USG   Baseline, 12 weeks  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/08/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Knee osteoarthritis (OA) is a prevalent condition that leads to chronic disability in older adults. Around 80% of people with OA over the age of 60 have restricted movement, and 25% have trouble completing daily tasks. In India, up to 20% of people who have knee pain and signs of OA document being unable to perform everyday tasks. Evidence from previous studies states that the strength of hip and core musculature has a direct effect on knee joint loading, which in turn leads to disease progression. Therefore. it is proposed that the current study examine the efficacy of targeted core-specific strengthening exercises in conjunction with a routine rehabilitation regimen for knee OA, and evaluate its effectiveness on pain, patient-reported functional outcomes, physical function tests, knee strength, core endurance and correlate its impact on cartilage health and disease severity. Patients with knee OA, who meet the inclusion criteria will be recruited and randomly allocated into intervention and control groups. Clinical assessments including outcome measures - VAS, patient-reported outcomes, physical function tests, and muscle strength will be assessed on baseline, 4 weeks, 8 weeks and 12 weeks. Diagnostic assessments including Xray and USG will be done at baseline and 12 weeks. Following 12 weeks, the effect of the intervention will be compared between groups and the results will be reported. 


 
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