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CTRI Number  CTRI/2025/02/080577 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 12/02/2025
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   Strengthening Strategies for Knee Osteoarthritis: Eccentric vs. Isometric Exercise 
Scientific Title of Study   Strengthening Strategies for Knee Osteoarthritis: A Randomized Trial of Eccentric vs. Isometric Exercise 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kazi Md Azman Hossain 
Designation  Intern Physiotherapist 
Affiliation  Jashore University of Science and Technology (JUST), Jashore 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh


7408
Other 
Phone  01660140833  
Fax    
Email  kmazman51@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kazi Md Azman Hossain 
Designation  Intern Physiotherapist 
Affiliation  Jashore University of Science and Technology (JUST), Jashore 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh


7408
Other 
Phone  01660140833  
Fax    
Email  kmazman51@gmail.com  
 
Details of Contact Person
Public Query  
Name  Abid Hasan Khan 
Designation  MPT Fellow 
Affiliation  Jashore University of Science and Technology (JUST), Jashore 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh


7408
Other 
Phone  01787378201  
Fax    
Email  abidhasankhan1997@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh. 
 
Primary Sponsor  
Name  Kazi Md Azman Hossain 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh. 
Type of Sponsor  Other [self-funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Md Kabir Hossain  Dr. M R Khan Medical Centre  Room no: 306, 2nd Floor, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore 7408, Bangladesh

 		 01778315139

kabir2002pt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board of Department of Physiotherapy and Rehabilitation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional care group  This group will receive 18 sessions of conventional care of the affected knee for total 6 weeks. 0n a stationary cycle ergometer, participants will complete the warm-up session by maintaining 40%–75% of HRR. After the warm-up, individuals with knee OA will complete hamstrings, calf, quadriceps, and iliotibial band stretching at 15-30 seconds hold/1 set each; recommended mobilization with movement, including patellar gliding for knee OA - 6-10 reps/1-3 sets; application of therapeutic pulsed ultrasound at 1-MHz/ 0.8 W/cm/ 5 minutes/ once a day (Use a 5cm2 diameter applicator) under the supervision of the physiotherapist. Finally, cool down for 5 minutes. 
Intervention  Eccentric exercise + conventional care (ECC group)  The ECC group will receive 15 sessions of eccentric knee flexor-extensor and hip extensor-abductor exercises along with 18 sessions of conventional care of the affected knee for total 6 weeks. On the first 3 sessions, on a stationary cycle ergometer, participants will complete the warm-up session by maintaining 40%–75% of HRR. After the warm-up, individuals with knee OA will complete hamstrings, calf, quadriceps, and iliotibial band stretching at 15-30 seconds hold/1 set each; recommended mobilization with movement, including patellar gliding for knee OA - 6-10 reps/1-3 sets; application of therapeutic pulsed ultrasound at 1-MHz/ 0.8 W/cm/ 5 minutes/ once a day (Use a 5cm2 diameter applicator) under the supervision of the physiotherapist. After that, during the 4th – 18th sessions, participants will perform: eccentric knee flexor exercise on a prone leg curl machine; eccentric knee extensor exercise on a thigh extension machine; eccentric hip extensor exercise on a Roman chair set 30° relative to the floor; and eccentric hip abductor exercise using a cable machine in the gymnasium; weight will be distributed according to the participants’ tolerance level and conditions - 10 reps/1-3 sets. Finally, cool down for 5 minutes. 
Intervention  Isometric exercise + conventional care (ISOM group)  The ISOM group will receive 15 sessions of isometric knee flexor-extensor and hip extensor-abductor exercises along with 18 sessions of conventional care of the affected knee for total 6 weeks. On the first 3 sessions, on a stationary cycle ergometer, participants will complete the warm-up session by maintaining 40%–75% of HRR. After the warm-up, individuals with knee OA will complete hamstrings, calf, quadriceps, and iliotibial band stretching for 15-30 seconds hold/1 set each; recommended mobilization with movement, including patellar gliding for knee OA - 6-10 reps/1-3 sets; application of therapeutic pulsed ultrasound at 1-MHz/ 0.8 W/cm/ 5 minutes/ once a day (Use a 5cm2 diameter applicator) under the supervision of the physiotherapist. After that during the 4th – 18th sessions participants will perform: the isometric exercise of knee flexor-extensor and hip extensor-abductor muscles - 10 reps/1-3 sets. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Individuals will be included in this trial if (1) ages 45 – 70 for both men and women, (2) the presence of knee OA for at least six months following American College of Rheumatology criteria, (3) able to walk without the use of any aids and able to flex the knee beyond 90 degrees, (4) anterior-posterior bilateral standing radiograph presents Kellgren and Lawrence Grade II/III knee OA, and (5) absence any unusual cardiac response during the six-minute walk test. 
 
ExclusionCriteria 
Details  Individuals will be excluded if (1) knee surgery has been performed in the previous twelve months, (2) lumbar radiculopathy, vascular claudication, severe anterior-sided knee pain resulting from patella-femoral syndrome or chondromalacia, as well as further neurological, muscular, or joint conditions that could impair the function of the lower limbs, (3) visible malformation of the knee, either varus or valgus, (4) Received hyaluronic acid or corticosteroid injections within three months of study enrollment, (5) pregnancy, and (6) BMI over 30 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain (Numeric Pain Rating Scale), Pressure Pain Threshold (Algometer), Muscle strength (Sphygmomanometer), Range of Motion (Goniometer)   At baseline, after 6 weeks and 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Functional ability (WOMAC), Walking ability (6MWT)   10 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="0" 
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)   28/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
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  

We plan to carry out a six-week randomized clinical trial. We will compare the effectiveness of eccentric and isometric exercises including a control group for participants with knee osteoarthritis. This study aims to determine the knee osteoarthritis-related sociodemographic characteristics, baseline comparison at the pretest, and determine the effectiveness of eccentric vs isometric exercise on pain, pressure pain threshold, muscle strength, range of motion, functional ability, and walking ability of knee osteoarthritis patients after completing interventions. There will be also a follow-up period of 24 weeks. We expect better treatment outcomes after 18 sessions of intervention for knee osteoarthritis participants who receive eccentric strengthening exercises along with conventional care.

 
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