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
|
|
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
|
|
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. |