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CTRI Number  CTRI/2025/05/086531 [Registered on: 07/05/2025] Trial Registered Prospectively
Last Modified On: 05/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   A Study to Compare the Effects of Core Strengthening and Functional Exercises on Knee Movement, Pain, and Quality of Life in People with Knee Osteoarthritis 
Scientific Title of Study   Effectiveness of Core Muscle Strengthening Versus Functional Task Training in Improving Range of Motion, Pain and Quality of Life in Individuals 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 Vaishnavi Gore 
Designation  Postgraduate Scholar 
Affiliation  MGM School Of Physiotherapy 
Address  MGM School of Physiotherapy, MGM campus N6 CIDCO, Chh. Sambhajinagar

Aurangabad
MAHARASHTRA
431003
India 
Phone  8446592318  
Fax    
Email  vaiishnavii09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rinkle Malani  
Designation  Director and Professor 
Affiliation  MGM School Of Physiotherapy 
Address  MGM School of Physiotherapy, MGM campus N6 CIDCO, Chh. Sambhajinagar

Aurangabad
MAHARASHTRA
431003
India 
Phone  9370312412  
Fax    
Email  rinkle.malani@mgmsop.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Rinkle Malani  
Designation  Director and Professor 
Affiliation  MGM School Of Physiotherapy 
Address  MGM School of Physiotherapy, MGM campus N6 CIDCO, Chh. Sambhajinagar


MAHARASHTRA
431003
India 
Phone  9370312412  
Fax    
Email  rinkle.malani@mgmsop.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  MGM School of Physiotherapy 
Address  MGM School of Physiotherapy, MGM Campus, N6 CIDCO, Chh. Sambhajinagar Maharashtra India 431003 
Type of Sponsor  Private medical college 
 
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 
Dr Vaishnavi Gore  MGM School of Physiotherapy  MGM School of Physiotherapy MGM campus, N6 CIDCO, Chh. Sambhajinagar Maharashtra India 431003
Aurangabad
MAHARASHTRA 		 8446592318

vaiishnavii09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Missions Ethics Committee for Research on Human Subjects  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 
Intervention  Core Muscle Strengthening  1st Week abdominal crunch 5 Repetitions x 3 sets (10 second hold each) 2nd Week 1st week exercise + abdominal sit back, quadruped opposite upper and lower extremity lift 5 Repetitions x 3 sets (10 second hold each) 3rd Week 2nd week exercise + supine lower extremity extender, horizontol side support 5 Repetitions x 3 sets (10 second hold each) 
Comparator Agent  Functional Task Training  1st Week Sit to stand, stand to sit 3 repetitons x 3 sets 2nd Week 1st week exercise + side kick, wearing a socks/ shoes 3 repetitons x 3 sets 3rd Week 2nd week exercise + kicking a ball, functional reachouts 3 repetitons x 3 sets 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients having knee pain since 3 months
2) age between 40-60 years, both male and female.
3) Patients having knee pain more than 3 score on NPRS scale.
4) Orthopaedician diagnosed knee osteoarthritis with Kellgren and Lawrence scale upto grade 3 
 
ExclusionCriteria 
Details  1) OA of any other joint (Rheumatoid arthritis, ankylosing spondylitis, gout, psoriatic arthritis,
hip arthritis)
2) Previous hip or knee surgery.
3) Received intra-articular injection within 6 months.
4) Received physiotherapy treatment for knee pain in past 6 months.
5) Impaired lower limb function due to stiff knee.
6) Genu valgum, genu varum or any other lower limb deformity 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Goniometer  At Baseline and after three weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Numerical Pain Rating Scale   At Baseline and after three weeks 
Knee Injury And Oseoarthritis Outcome Score (KOOS)  At Baseline and after three weeks 
Dynamometer  At Baseline and after three weeks 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   30/05/2025 
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="1"
Months="0"
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   This randomized clinical trial aimed to compare the effectiveness of core muscle strengthening versus functional task training in improving range of motion (ROM), pain, and quality of life in individuals with knee osteoarthritis. Participants were randomly assigned to two groups: one received core muscle strengthening exercises, while the other underwent functional task-based training. Both interventions were administered over a defined period under supervised conditions. Outcomes were measured using standardized tools, including goniometry for ROM, the Visual Analogue Scale (VAS) for pain, and the WOMAC index for quality of life. The results demonstrated that both interventions significantly improved ROM, reduced pain, and enhanced quality of life. However, functional task training showed comparatively greater improvements, particularly in functional mobility and daily activity performance. The study concludes that while core strengthening is beneficial, functional task training may offer superior overall outcomes in managing knee osteoarthritis symptoms and promoting better patient-centered functional recovery. 
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