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CTRI Number  CTRI/2024/06/068737 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 11/06/2024
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   Effect of Eccentric Strengthening Exercise in patients with Knee Osteoarthritis : A Randomized Controlled Trial 
Scientific Title of Study   Effect of Eccentric Strengthening Exercise in Knee Osteoarthritis 
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  Final Year Bachelor of Physiotherapy (BPT) 
Affiliation  Jashore University of Science and Technology (JUST) 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore



7408
Other 
Phone  8801660140833  
Fax    
Email  azmanhossain51@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Md Zahid Hossain 
Designation  Assistant Professor and Chairman  
Affiliation  Jashore University of Science and Technology (JUST) 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore



7408
Other 
Phone  8801670962775  
Fax    
Email  mz.hossain@just.edu.bd  
 
Details of Contact Person
Public Query  
Name  Dr Kazi Md. Amran Hossain 
Designation  Lecturer 
Affiliation  Jashore University of Science and Technology (JUST) 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore



7408
Other 
Phone  8801735661492  
Fax    
Email  kma.hossain@just.edu.bd  
 
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, Jashore University of Science and Technology, Jahsore-7408, Bangladesh.  Room no: 306, 2nd Floor, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh.

 		 8801778315139

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: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy  Participants will begin each session with a 5-minute warm-up on a stationary cycle ergometer at low rate (50 rpm) & low load (1Kp) [20, 37]. After warm-up, patients’ will complete one set of hamstrings, calf, quadriceps, and iliotibial band stretching for 3 repetitions with 30 seconds hold during each repetitions; isometric strengthening exercise for 10 repetitions with 5 seconds hold × 1-2-3 sets on the quadriceps, and hip adductor muscle; mobilisation with movement for 6-10 repetitions × 3 sets; patellar glides at two to three oscillations/sec for 2 minutes in all directions as 3-6 repetitions; therapeutic ultrasound in continuous mode (1 watt/cm2 dose, 1 MHz) for 5 minutes and apply with a 5cm diameter applicator under the supervision of the physiotherapist. Applicable for every exercise: 10s rest between each set & 20s rest between different modes of exercise & 5m rest between right & left knee exercise. Duration of treatment 45 minutes of each session, 3 sessions per week for 5 weeks.  
Intervention  Eccentric Strengthening Exercise with Conventional Physiotherapy  Participants will begin each session with a 5-minute warm-up on a stationary cycle ergometer at low rate (50 rpm) & low load (1Kp) [20, 37]. After warm-up, patients’ will complete one set of hamstrings, calf, quadriceps, and iliotibial band stretching for 3 repetitions with 30 seconds hold during each repetitions; isometric strengthening exercise for 10 repetitions with 5 seconds hold × 1-2-3 sets on the quadriceps, and hip adductor muscle; mobilisation with movement for 6-10 repetitions × 3 sets; patellar glides at two to three oscillations/sec for 2 minutes in all directions as 3-6 repetitions; therapeutic ultrasound in continuous mode (1 watt/cm2 dose, 1 MHz) for 5 minutes and apply with a 5cm diameter applicator under the supervision of the physiotherapist. After receiving conventional care participants will receive eccentric knee flexion-extension strengthening exercise for 10 repetitions × 3 sets on quadriceps table; eccentric hip abduction strengthening exercise for 10 repetitions × 3 sets by strapping sand bag to the ankle of the patient; weight will be distributed according to patient tolerance level and conditions; 1-4 Session: 50% of 10 RM; 5-8 Session: 75% of 10 RM; 9-15 Session: 100% of 10 RM. Applicable for every exercise: 10s rest between each set & 20s rest between different modes of exercise & 5m rest between right & left knee exercise. Duration of treatment 45 minutes of each session, 3 sessions per week for 5 weeks.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  i. Presence of Unilateral/Bilateral Knee osteoarthritis for at least six months, according to American College of Rheumatology criteria. ii. Tibiofemoral osteoarthritis-related knee pain and discomfort. iii. Capable of walking without the use of gait aids, and able to flex the knee beyond 90 degrees. iv. Anterior posterior bilateral standing radiograph presenting Kellgren and Lawrence Grade II/III Knee osteoarthritis. v. Providing consent of completion five week intervention and capable to carry with upon it. vi. Without suffering any unusual cardiac response during the six minute walk test. 
 
ExclusionCriteria 
Details  i. Any knee surgery performed in the previous twelve months. ii. Lumbar radiculopathy, vascular claudication, severe anterior knee pain resulting from isolated patella femoral syndrome or chondromalacia in the knee, as well as further neurological, muscular, or joint conditions that could impair the function of the lower limbs. iii. Visible malformation of the knee, either varus or valgus. iv. Received hyaluronic acid or corticosteroid injections within three months of study enrollment; within two months, added new OTC or prescription painkillers. v. Pregnancy. vi. Mental or language obstacles limiting protocol implementation. vii. BMI over 30.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
pain intensity, pressure pain threshold, strength, range of motion, and functional disability and depression severity of knee osteoarthritis patients.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Range of motion, and six-minutes walk test and depression severity  6 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)   20/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/06/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Applicable 
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 five weeks randomized controlled trial. We will compare the effectiveness between eccentric strengthening exercise along with conventional care and conventional care only for patient with knee osteoarthritis. This study aims to determine the knee osteoarthritis-related sociodemographic characteristics, baseline comparison at pretest and determine the effectiveness of eccentric strengthening exercise on pain, pressure pain threshold, strength, range of motion, functional disability, six minutes walk test and depression severity of knee osteoarthritis patients during posttest and follow-up also. We expect better treatment outcome after 15 sessions of intervention for knee osteoarthritis patients who receive eccentric strengthening exercise along with conventional care. 
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