| CTRI Number |
CTRI/2022/12/047934 [Registered on: 07/12/2022] Trial Registered Prospectively |
| Last Modified On: |
16/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Deep squat exercises for osteoarthritis of Knee |
|
Scientific Title of Study
|
Deep squat exercise-exploration of a novel, early self-administered prophylactic tool to delay disability caused by osteoarthritis of knee - a longitudinal study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor Director |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
Department of Physiotherapy Integrated OPD 1st Floor room no-115 MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
rmullerpatan@mgmsopnm.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor Director |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
Department of Physiotherapy Integrated OPD 1st Floor room no-115 MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
rmullerpatan@mgmsopnm.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor Director |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
Department of Physiotherapy Integrated OPD 1st Floor room no-115 MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
rmullerpatan@mgmsopnm.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Health Sciences infrastructure and material support |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Health Sciences |
| Address |
MGM Educational Campus Plot no 1 and 2 Kamothe Taluka Panvel
District Raigad 410209
|
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajani Mullerpatan |
MGM School of Physiotherapy MGM Institute of Health Sciences |
Department of Physiotherapy Out Patient Department, 1st Floor room no-115
Sector 1 Kamothe Navi Mumbai
410209
Raigarh
MAHARASHTRA |
02227437667
rajani.kanade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Missions Dental College and Hospital Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
No exercises but will be administered. But can do all their activities of daily living as usual |
| Intervention |
Deep squat dosimetry exercises |
Deep squat intervention will be given in the form of progressive squatting exercises. Participants will perform 5 sets of deep squats performed at pre determined frequency based on a metronome, interspersed with rest period of 1 min. In the event of fatigue, participants can discontinue the session and number of repetitions performed would be noted. Supervised sessions will be conducted by a Physiotherapist once a week with participants continuing their exercises at a frequency of 5 times/week at home. Deep squat repetitions will be progressed by 20% every three weeks to obtain the benefits of increased intensity of activity. Daily recording of exercise session in a dairy will be maintained by the participant and will be used for monitoring deep squat exercise protocol.
For the early OA knee group Following determining of deep squat dosimetry, deep squat exercises will be prescribed for people with osteoarthritis grade 1-2. The squat intervention will be progressed as in healthy people till people are able to perform 100 squats per day and will be instructed to continue training for one yearFor the early OA knee group Following determining of deep squat dosimetry, deep squat exercises will be prescribed for people with osteoarthritis grade 1-2. The squat intervention will be progressed as in healthy people till people are able to perform 100 squats per day and will be instructed to continue training for one year |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
pre OA people (non squatters-30-50 years) in the age group of 30-50yr will be recruited for the study. People will be screened for inclusion based on X ray findings to confirm pre OA status.
|
|
| ExclusionCriteria |
| Details |
People engaging in specific sports, recreational physical activity or rehabilitation programs, Females who have undergone menopause , Traumatic, degenerative ,autoimmune ,developmental musculoskeletal or neurological disorders, Cardiovascular and pulmonary disorders , Resting blood pressure >150/90mmHg, Cognitive issues which will prevent comprehension of instructions
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| biomechanical demands of squat by recording kinetic (forces), kinematic (joint angles), length and activity of muscle (EMG) and neuro-physiological control (postural control). Cellular biochemical response to activity will be assessed by non invasive methods to evaluate anti oxidant activity in body fluids like sweat and urinary cartilage C talopeptide type II collagen. |
baseline, 4 weeks, 8 weeks , 12 weeks, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| participants will undergo prescreening using American College of Sports Medicine ACSM risk factor profile, Physical Activity Readiness Questionnaire (PARQ), Health History Questionnaire (HHQ), International Physical Activity Questionnaire-Short Version (IPAQ), Physiological Stress Scale, Western Ontario Mac Master University Questionnaire (WOMAC )/WOMAC CRD Pune version. Previous squatting exposure will be quantified using MGM Ground Level Activity Exposure questionnaire(MGMGLAE) |
baseline, 4 weeks, 8 weeks , 12 weeks, 12 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
02/01/2023 |
| 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="2"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current study aims to define dosimetry of deep squat intervention by comparing three groups of healthy pre OA people (30-50 year old non squatters) based on performance on 30 second deep squat test which reflects on lower limb muscle strength. To demonstrate the effect of deep squat intervention on structural changes in articular cartilage on MRI, biochemical changes on biomarker and disability related variables on biomechanical investigation by implementing the dose specific intervention in people with Grade1-2 OA knee (Kellegren Lawrence grading) with a follow up of one year. Data will be collected and analysed at baseline , 4 week , 8 week. 12 week and 12 months |