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CTRI Number  CTRI/2025/04/084910 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 16/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   How the Intervention which is going to be given will improve capacity of Knee Muscles in Participants with Knee Osteoarthritis? 
Scientific Title of Study   Effectiveness of Endurance Exercise for Knee Muscles in Persons with Osteoarthritis of Knee-A Quasi-Experimental Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saraswathi K 
Designation  Student  
Affiliation  SRM Institute of science and technology 
Address  Room NO.PT 22,4th floor,SRM College of Physiotherapy,SRM Medical College,kattankulathur Campus,Kancheepuram district,Tamil Nadu

Kancheepuram
TAMIL NADU
603203
India 
Phone  9123553469  
Fax    
Email  shakthisaras321@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Harikrishnan R 
Designation  Associate Professor 
Affiliation  SRM Institute of science and technology 
Address  Room NO.PT 31,4th floor,SRM College of Physiotherapy,SRM Medical College,kattankulathur Campus,Kancheepuram district,Tamil Nadu

Kancheepuram
TAMIL NADU
603203
India 
Phone  7358305299  
Fax    
Email  harikrir@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  DR Harikrishnan R 
Designation  Associate Professor 
Affiliation  SRM Institute of science and technology 
Address  Room NO.PT 31,4th floor,SRM College of Physiotherapy,SRM Medical College,kattankulathur Campus,Kancheepuram district,Tamil Nadu

Kancheepuram
TAMIL NADU
603203
India 
Phone  7358305299  
Fax    
Email  harikrir@srmist.edu.in  
 
Source of Monetary or Material Support  
Room no.20,C-1,Outpatient physiotherapy department,SRM Medical College Hospital and Research Centre,Kattankulathur,Kancheepuram,Tamil Nadu,India,603203 
 
Primary Sponsor  
Name  Saraswathi. K 
Address  Room NO.PT 22,4th floor,SRM College of Physiotherapy,SRM Medical College,kattankulathur Campus,kancheepuram district,Tamil Nadu 
Type of Sponsor  Other [Self funded] 
 
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 
DrSaraswathiK  SRM Medical College Hospital and Research Centre  Room no.20,C-1,Outpatient physiotherapy department,SRM Medical College Hospital and Research Centre,Kattankulathur,Kancheepuram,Tamil Nadu,603203
Kancheepuram
TAMIL NADU 
9123553469

shakthisaras321@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM MEDICAL COLLEGE HOSPITAL & RESEARCH CENTRE  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  Controlled group  Wax therapy (3 dips for 5 days) if the range of motion is restricted less than 100o or interferential therapy (program:12 for 15 minutes for 5 days) if the range of motion is more than 100o . Exercises: Static quadriceps, Calf strengthening , Hamstring strengthening ,Hamstring, Abductor and Adductor isometrics (10 counts x 10 hold x 2 time) 
Intervention  Endurance Exercise  Wax therapy (3 dips for 5 days) if the range of motion is restricted less than 100o or interferential therapy (program:12 for 15 minutes for 5 days) if the range of motion is more than 100o . Exercises: Static quadriceps, Calf strengthening , Hamstring strengthening ,Hamstring, Abductor and Adductor isometrics (10 counts x 10 hold x 2 time).Nordic hamstring exercise will be given for hamstring endurance. In the first week 2 sets with 5 repetitions till 5th week and then increase the no of sets to 3 and repetitions gradually every week for nordic hamstring exercise The patient will be supported by a therapist from behind, the patient is in a kneeling position with a 90-degree knee flexed and ask him to lean forward and push backwards immediately.For quadriceps endurance, cycle ergometer training will be given.3 times a week for 8 weeks (35 minutes).  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients with greater than or equal to 4 in NPRS
2.patient age greater than or equal to 50 years
3.patient with OA knee based on American College of Rheumatology criteria
4.no recent history of knee surgery or joint replacement
5.patient who is willing to involve in the study
 
 
ExclusionCriteria 
Details  1.History of Cardiorespiratory Disease
2.History of any Neurological disorders
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Quadriceps and Hamstring Endurance.
 
Baseline and 8 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.Pain
2.Quality of life
3.Activities of daily living  
8 weeks 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   29/04/2025 
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="0"
Months="9"
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  
Patients will be selected based on the inclusion and exclusion criteria. The Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Numeric Pain Rating Scale (NPRS) will be used to assess pain, function, and disability in
patients with knee osteoarthritis (OA).To evaluate endurance, the Fatigue Resistance Test and the Sit-to-Stand Test will be conducted to assess quadriceps and hamstring endurance, respectively. Patients will then be divided into two groups, with 35 patients in each group: 1.Control Group: This group will receive standard exercises formulated during a panel discussion among the clinical staff in the Physiotherapy Outpatient Department at SRM General Hospital. 2.Experimental Group: In addition to the same protocol as the control group, this group will receive hamstring and quadriceps endurance exercises. For hamstring endurance, the Nordic Hamstring Exercise will be administered. During the first five weeks, 2 sets of 5 repetitions will be performed. From the sixth week onwards, the number of sets will increase to 3, with repetitions gradually increasing each week. In this exercise, the patient, supported by a therapist from behind, will kneel with the knees flexed at 90 degrees, lean forward, and then push backward immediately. In addition to the Nordic Hamstring Exercise, the experimental group will use a cycle ergometer for 35 minutes, three times a week, for eight weeks. At the end of the intervention period, KOOS, as well as endurance tests for the hamstrings and quadriceps, will be conducted to evaluate the outcomes.
 
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