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CTRI Number  CTRI/2024/01/061127 [Registered on: 04/01/2024] Trial Registered Prospectively
Last Modified On: 28/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect of Home Based Structured Exercise in Individuals with Knee Osteoarthritis 
Scientific Title of Study   The Effect of a Structured Home Based Exercise Program on the Functional Outcome in Patients with Knee Osteoarthritis and its Predictors for Successful Outcome  
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 Semi Hangma Maden 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Physical Medicine & Rehabilitation, All India Institute Of Medical Sciences, Ansari Nagar New Delhi
Hostel 19 All India Institute of Medical Sciences Resident Doctors Hostel, Patanjali Hostel, Masjid Moth, South Delhi
New Delhi
DELHI
110049
India 
Phone  9773584487  
Fax    
Email  semimaden.jan22@aiims.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Asem Rangita Chanu 
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences 
Address  Department of Physical Medicine & Rehabilitaion, All India Institute of Medical Sciences, Ansari Nagar, New Delhi

New Delhi
DELHI
110049
India 
Phone  7598621688  
Fax    
Email  rangita8@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Semi Hangma Maden 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Physical Medicine & Rehabilitation, All India Institute of Medical Sciences, Ansari Nagar

New Delhi
DELHI
110049
India 
Phone  9773584487  
Fax    
Email  semimaden.jan22@aiims.edu  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  All India Institute of Medical Sciences, Ansari Nagar, New Delhi  
Type of Sponsor  Research institution and hospital 
 
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 Semi Hangma Maden  All India Institute Of Medical Sciences  Department of Physical Medicine & Rehabilitaiton, All India Institute Of Medical Sciences, Ansari Nagar
South
DELHI 
9773584487

semimaden.jan22@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research   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 
Comparator Agent  6 minute walking test Knee Osteoarthritis Outcome Scale  Patient will be asked to perform a 6 min walking test and fill Knee Osteoarthritis Outcome Scale forms before, during and after the study. These three values will be compared. 
Intervention  Structured Home Based Exercise Program  25 mins of Strengthening exercise (Quadriceps, Hamstrings and Hip extensors), stretching exercise (Hamstring and Tendoachilles) and neuromuscular training exercise two times daily.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Diagnosed case of OA knee as per ACR revised Criteria for early diagnosis of knee OA
2. All Kellgren & Lawrence grades of OA knee (TF) including those waitlisted for surgery for more than 8 weeks.
3. Patient of either sex and age > 40 years
4. Ability to comprehend Hindi or English and follow commands 
 
ExclusionCriteria 
Details  1. H/o surgical intervention in lower limbs.
2. H/o lower limb fractures.
3. Other lower limb osteoarthropathy (RA or other joint disease)
4. Any other disabling conditions (e.g. back pain or widespread pain)
5. Neurological disease.
6. History of knee intraarticular injections (steroid, PRP, hyaluronic acid etc) past 2 months.
7. Secondary Knee OA
8. Patient with Cognitive difficulties
9. Patients contraindicated to perform 6 MWT(eg. Unstable angina/MI in past 1 month) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
6 minute walk test  At Baseline, 4th week and 8th week 
 
Secondary Outcome  
Outcome  TimePoints 
Knee Injury & Osteoarthritis Outcome Scale  At Baseline, 4th week & 8th week 
 
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 2 
Date of First Enrollment (India)   09/01/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Knee OA is a leading cause of functional limitation among older adults. There are a number of treatment options available, both pharmacological and non-pharmacological, in combination. Non-pharmacological treatment options include exercises, physical modalities, orthoses, interventions or surgery (at late stages).

Exercises are known to be associated with better outcomes when supervised, which is not practical at most times. So, a proper structured home-based exercise  program might be more practical in these patients. These measures are believed not only to reduce pain, but also improve the functional outcome of the patients. Hence, we want to know the functional outcomes of a proper structural home based exercise in Knee Osteoarthritis patients.

Also various factors are known to affect the response to the available treatments for individuals with Knee OA. An understanding of such predictors for a successful outcome will help to provide a broader perspective to health practitioners. Thus, we will also try to find predictors for successful outcomes in these patients.

All patients coming to AIIMS, PMR-OPD with the complaint of knee pain will be thoroughly examined after taking detailed history for possibility of enrolling in the study. Those who have Knee OA as per revised ACR criteria for early diagnosis of Knee OA, will be advised plain X ray of knee AP (weight bearing position) and skyline view to know the severity as per Kellgren & Lawrence (KL) grading.  All patients with KL Grades of OA knee (TF) including those waitlisted for surgery more than 8 weeks, will be enrolled in the study after ruling out the exclusion criteria and after taking a written informed consent.

After enrolling in the study, all patients will be required to undergo a triple phase bone scan with single-photon emission computed tomography-computed tomography (SPECT/CT). 

All patients will also be asked to do a 6MWT to note down the distance walked by the patient in 6 minutes, which will indicate the status of function. All enrolled patients will also be asked to fill up the KOOS questionnaire.

The structured exercise program will comprise of aerobic/warm-up, strengthening exercises (quadriceps, hip extensors and hamstrings), stretching exercises (tendoachilles, hamstrings, quadriceps) and neuromuscular control exercises. After 2 weeks, all participants will be given a telephone call to reinforce the exercises and other advices, as well as to find out if they have any issues/doubts. They will be followed up physically after 4 weeks and will be required to undergo another 6MWT and to fill up the KOOS questionnaire. Last follow up will be done at the end of 8 weeks where 6MWT and KOOS questionnaire filling up is again done. A Patient Global Impression of Change (PGIC) will also be asked to be filled up by the patient at 8 weeks to know their overall status since the start of the study. Categories of ’very much improved’ and ’much improved’ in PGIC will be considered as successful outcome in our study.

 
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