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CTRI Number  CTRI/2024/11/076155 [Registered on: 01/11/2024] Trial Registered Prospectively
Last Modified On: 01/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Functional strength training in knee osteoarthritis. 
Scientific Title of Study   Effect of functional strength training on sit to stand and functional outcome in Knee Osteoarthritis: A randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sachin Gupta 
Designation  Assistant Professor  
Affiliation  Galgotias University 
Address  Room no. B228 department of physiotherapy SAHS Galgotias University plot no. 2 yamuna expy opposite buddha international circuit sector 17A Greater Noida Uttar Pradesh India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9015193829  
Fax    
Email  sachinguptapt3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tanisha Shakya 
Designation  Research Student  
Affiliation  Galgotias University 
Address  Room no. E005 department of physiotherapy SAHS Galgotias University plot no. 2 yamuna expy opposite buddha international circuit sector 17a Greater Noida Uttar Pradesh India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  8791225846  
Fax    
Email  shakyat030@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sachin Gupta 
Designation  Assistant Professor  
Affiliation  Galgotias University 
Address  Room no. B228 department of physiotherapy SAHS Galgotias University plot no. 2 yamuna expy opposite buddha international circuit sector 17A Greater Noida Uttar Pradesh India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9015193829  
Fax    
Email  sachinguptapt3@gmail.com  
 
Source of Monetary or Material Support  
Research and Development Cell, Galgotias University, India , 203201 
 
Primary Sponsor  
Name  Galgotias University  
Address  Room No A315 Research and Development Cell, Galgotias University, Plot No 2, Sector 17A, Yamuna Expy, opposite Buddha International circuit, Greater Noida Uttar Pradesh 203201  
Type of Sponsor  Research institution 
 
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 
Dr Sachin Gupta   Galgotias University  Plot No 2, Sector 17A Opposite Gautam Buddha International Circuit, Yamuna expressway Gautam Buddha Nagar UTTAR PRADESH Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH 
9015193829

sachinguptapt3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Research Committee Galgotias University Uttar Pradesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Functional Strength training   Functional strength training (FST) is gaining popularity as a new kind of exercise for people with heart conditions, middle-aged adults, athletes, and the elderly. It has been shown to improve health, help people control their weight, and improve daily activity performance. FST simulates specific movements that call for balance, strength, flexibility, and coordination. 1 week Chair rise Forward reach to opposite foot Forward walking Side step walking Combined forward and backward walking At preferred speed (5 rep) 2 week Same exercises of 1st week at fast speed Step up forward/down Marching Squatting Forward and upward reach Upper body rotation At preferred speed (5rep) 3 week Same exercises of 1st week at slow speed Same exercises of 2nd week at fast speed (5rep) 4 week Same exercises of 1st week with adding difficulty (such as adding weight of any object) Same exercises of 2nd week at slow speed (7 rep) 5 week Same exercises of 1st week at slow speed with difficulty Same exercises of 2nd week with more difficulty (10rep) 6 week Same exercises as 1st & 2nd week protocol with changing the environment (10 rep)  
Comparator Agent  NIL   NIL 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1 Pre-diagnosed with knee OA
2 Radiographic imaging.
3 Kellgren-Lawrence scale 1,2,3.
4 Both genders are affected
 
 
ExclusionCriteria 
Details  1 Any history of trauma, fracture, or surgery like total knee replacement (TKR).
2 Sever mobility-related comorbidities (e.g., neurological disorders, sever cardiovascular conditions).
3 Mortin IB, Naproxen sodium is also the first-line treatment for patients with symptomatic osteoarthritis.
4 Intra-articular hyaluronic acid injections (HA) injections and Vit B12 are another injectable option for knee osteoarthritis.
5 Deformity varus and valgus.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Five-Times Sit-to-Stand Test
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 
Baseline AND 6 WEEKS  
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 1 
Date of First Enrollment (India)   12/11/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   Subjects fulfilling the inclusion and exclusion criteria will be asked to sign the informed consent form. The subjects will be informed in detail about the procedure of the study and will complete the data collection form. Subjects selected for the study will be randomly allocated to two groups— the experimental group i.e., group A, and an even number of participants will be allocated to the control group i.e., group B.

Five-Times Sit-to-Stand Test: Measures lower body strength and endurance by timing how long it takes to stand up and sit down five times. Five-time sit-to-stand test- The participant must stand up and sit down five times as quickly as they can without using their hands to propel themselves out of a chair during the five-time STS. A portable stopwatch was used to record the amount of time it took to complete the assignment. A typical armless chair, measuring 43–47 cm in height, was utilized. To maintain stability and safety, the chair’s back ought to be secured against a wall. To avoid using his or her hands, the subject was told to fold his or her arms across his or her chest. The experiment begins when the subject is given the go-ahead by the researcher and ends when the subject, after five repetitions, fully reclines in the chair with his or her back resting against the chair’s back.

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire that assesses pain, stiffness, and physical function in patients with hip or knee osteoarthritis. The Western Ontario MacMaster (WOMAC) is a validated instrument designed specifically for the assessment of lower extremity pain and function in osteoarthritis (OA) of the knee . WOMAC, a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), with items rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The reliability and validity of the WOMAC total score and subscales have been confirmed. The WOMAC has been widely used in trials of behavioral interventions for knee OA, confirming its sensitivity to change.


 
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