| 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
|
|
|
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
|
|
|
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. |