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CTRI Number  CTRI/2017/08/009457 [Registered on: 23/08/2017] Trial Registered Retrospectively
Last Modified On: 23/08/2017
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   exercise for hip muscle strengthening in total knee replacement surgery 
Scientific Title of Study   Effectiveness of exercise based rehabilitation on quality of life and functional outcome following total knee replacement – A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karvannan H 
Designation  Assistant Professor - Selection Grade 
Affiliation  SOAHS, Manipal University 
Address  No, 98, Rustum Bagh, Old airport road Manipal Hospital Bangalore

Bangalore
KARNATAKA
560017
India 
Phone  9986565966  
Fax    
Email  karvannan.h@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr RD Chakravarty 
Designation  Head, Joint replacement surgeon 
Affiliation  Manipal Hospital 
Address  No, 98, Rustum Bagh, Old airport road Manipal Hospital Bangalore

Bangalore
KARNATAKA
560017
India 
Phone  9845013441  
Fax    
Email  rajajanta.5@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arun G Maiya 
Designation  Professor 
Affiliation  SOAHS, Manipal University 
Address  Department of Physiotherapy, SOAHS, Manipal University, Madhav nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  arun.maiya@manipal.edu  
 
Source of Monetary or Material Support  
No,98, Rustum Bagh, old Airport Road, Department of Physiotherapy, Manipal Hospital, Bangalore- 560017 
 
Primary Sponsor  
Name  Manipal University 
Address  Department of physiotherapy, SOAHS, Madhav nagar, Manipal Univeristy, Manipal 
Type of Sponsor  Research institution and hospital 
 
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 
H Karvannan  Manipal Hospital   Department of Physiotherapy, Upper Basement, No, 98, old Airport Road, Rustum bagh, Bangalore
Bangalore
KARNATAKA 		 9986565966

karvannan.h@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Manipal Hospital and Manipal Heart Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Knee Osteoarthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Exercise Based rehabilitation for hip muscles  Exercises given for hip abductor muscles and knee extensor muscles following total knee replacement for those who diagnosed with knee osteoarthritis. Exercises was given for 4-5 sessions per week with each sessions lasts about 45-60 minutes of duration.Exercise Intervention was given for a duration of 3 months. 
Comparator Agent  Exercise for knee extensor muscles  Exercise given for knee extensor muscle following total knee replacement for those who diagnosed with knee osteoarthritis. Exercises was given for 4-5 sessions per week with each sessions lasts about 45- 60 minutes of duration.Exercise Intervention was given for a duration of 3 months. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Participants aged between 50-75 years.
Diagnosed with primary osteoarthritis of knee joint either right or left knee followed by total knee replacement.
 
 
ExclusionCriteria 
Details  Participants who underwent revision total knee replacement.
Participants who underwent bilateral total knee replacement.
A total hip replacement and/or other orthopedic surgery in either leg in the past year.
Participants with the history of associated neurological problems, which may alter the lower extremity performance.
Participants who were unable to walk and follow commands.
Participants who cannot tolerate treatment positions and exercise intensity due to diagnosed medical and pulmonary dysfunction.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Short Form - 36  Pre intervention and 12 weeks post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Hip Abductor strength  Pre intervention, 4 weeks post intervention and 12 weeks post intervention 
Knee Injury and Osteoarthritis Outcome Score   Pre intervention, 4 weeks post intervention and 12 weeks post intervention 
Six Minute walk test  Pre intervention, 4 weeks post intervention and 12 weeks post intervention 
Numeric Pain rating scale  Pre intervention, 4 weeks post intervention and 12 weeks post intervention 
Timed Up and Go test  Pre intervention, 4 weeks post intervention and 12 weeks post intervention 
Knee extensor strength  Pre intervention, 4 weeks post intervention and 12 weeks post intervention 
 
Target Sample Size   Total Sample Size="136"
Sample Size from India="136" 
Final Enrollment numbers achieved (Total)= "136"
Final Enrollment numbers achieved (India)="136" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/10/2012 
Date of Study Completion (India) 29/06/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The main objective of the trial is to find the effect of exercise based rehabilitation focusing on hip abductor muscles on the quality of life using SF- 36 survey and functional outcome using six-minute walk test and timed up and go test. At 3 months duration improvements were observed in both the intervention groups for quality of life measured using SF-36. Hip abductor strengthening group showed enhanced function on performance based function measured using six-minute walk test and timed up and go test after total knee replacement than conventional therapy alone. 
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