| CTRI Number |
CTRI/2025/05/087395 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Feasibility of home based exercise program with audiovisual guidance for knee osteoarthritis patients in India. |
|
Scientific Title of Study
|
Feasibility of adhoc-structured audiovisual exercise set for home based exercises in Indian knee osteoarthritis patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swarangi Virkud |
| Designation |
postgraduate student |
| Affiliation |
Terna Physiotherapy College |
| Address |
III Floor Terna medical college campus
Sector 12 Nerul West Near Sarsole Depot
Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9969203580 |
| Fax |
|
| Email |
swarangivirkud@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSwati Meshram |
| Designation |
Professor |
| Affiliation |
Terna Physiotherapy College |
| Address |
III Floor Terna medical college campus
Sector 12 Nerul West Near Sarsole Depot
Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9076455058 |
| Fax |
|
| Email |
swatimeshram@ternapt.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DrSwati Meshram |
| Designation |
Professor |
| Affiliation |
Terna Physiotherapy College |
| Address |
III Floor Terna medical college campus
Sector 12 Nerul West Near Sarsole Depot
Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9076455058 |
| Fax |
|
| Email |
swatimeshram@ternapt.ac.in |
|
|
Source of Monetary or Material Support
|
| TPCTs Terna Physiotherapy College
III Floor Terna medical college campus
Sector 12 Nerul West Near Sarsole Depot
Navi Mumbai 400706 India |
|
|
Primary Sponsor
|
| Name |
TPCTs Terna Physiotherapy College |
| Address |
TPCTs Terna Physiotherapy College
III Floor Terna medical college campus
Sector 12 Nerul West Near Sarsole Depot
Navi Mumbai 400706 India |
| 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 Swarangi Virkud |
TPCTs Terna Physiotherapy College Navi Mumbai |
III Floor Terna medical College campus
Sector 12 Nerul West Near Sarsole Depot
Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9969203580
swarangivirkud@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TPCTs Terna Physiotherapy College Navi Mumbai |
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 |
| Intervention |
Audiovisual exercise set for Home based exercises |
All the participants will be explained about the study in a language best understood by them and a written consent form will be taken
To achieve the purpose of the study osteoarthritic patients will be selected by convenience sampling
Participants will be given a 3 week exercise program
Pre exercises assessment will be done as mentioned and in Case Record Form and all the indices as mentioned above Muscle strength will be checked using manual muscle testing Patients will be instructed and trained in person for the use of exercises Relative or caretaker will be instructed to keep a check if the patient did exercises Daily diary of the patient will be maintained with Exercise Adherence Scale Patients will be reminded for exercises daily at their convenient timings Auto set reminders will be sent to patients individually At the end of every week adherence will be checked using Sport Injury Rehabilitation Adherence Scale SIRAS
Exercise videos will be sent on mobile through the WhatsApp group Instruction regarding exercises will be given in Hindi and Marathi as well Exercises from the given set will be customized as per durability assessment and pain tolerance of patients
After 3 weeks of the exercise program all the indices including feedback form will be assessed and sent to the participant
Exercise Program for 3 weeks
Exercises set is aimed to strengthen the Quadriceps Hamstring muscles Core muscles Gluteus medius and Gluteus minimus muscles
Static quadriceps 6 to 10 repetitions 10 seconds hold 3 sets
Static hamstring 6 to 10 repetitions 10 seconds hold 3 sets
Straight leg raise in supine 6 to 10 repetitions 10 seconds hold 3 sets
Straight leg raise in side lying 6 to 10 repetitions 10 seconds hold 3 sets
In prone position hip extension with knee flexion 6 to 10 repetitions 10 seconds hold 3 sets
In sitting position dynamic quadriceps exercise 6 to 10 repetitions 10 seconds hold 3 sets |
| Comparator Agent |
Not Applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient Who have already undertaken physiotherapy exercises for at least session
Knee OA patients who are aware of and doing some kind exercises like yoga
Individuals who are trainable for given exercises set
45 to 80 years patient diagnosed with osteoarthritis
Patient who possess and are able to use the internet and smartphone
Patients who have mild to moderate pain during activity |
|
| ExclusionCriteria |
| Details |
Patient who cannot handle phone and internet
Comorbidities that affect exercise programs include previous stroke cardiac disease visual and hearing impairments etc
Patients who are not trainable for any reason eg Cognitive impairments and understanding of exercises.
Patient who have Risk of fall.measured on time up and go test
Patients who have undergone for surgical procedures due to knee Osteoarthritis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Exercise Adherence
Sports Injury Rehabilitation Adherence Scale
3.Visual Analogue Scale
4.Time Up and Go Test
5.Patient Specific Functional Scale
6.Knee Injury and Osteoarthritis Outcome Score
7. Time Up and Go test
|
pretreatment
posttreatment 1st week
posttreatment 2nd week
posttreatment 3rd week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time up and go test
KOOS |
Pretreatment
Posttreatment 1st week
Posttreatment 2nd week
Posttreatment 3rd 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)
|
01/06/2025 |
| 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 Yet Recruiting |
| 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
|
Osteoarthritis is a chronic degenerative joint condition causing pain stiffness swelling and reduced function significantly affecting quality of life In India the prevalence is estimated between 22 to 39 which presents a major public health burden Affected individuals especially older adults often face barriers such as aging obesity low socioeconomic status and travel difficulties that limit their access to physiotherapy services As a result home based exercise programs could be a practical solution to improve their condition The proposed study aims to evaluate the feasibility of an ad hoc structured audiovisual exercise set designed for home based use by Indian patients with knee osteoarthritis This will include a three week intervention using a video based exercise program delivered via smartphones supported by regular reminders and adherence tracking The study will adopt a mixed method design combining quantitative and qualitative approaches A total of 30 participants who meet inclusion criteria will be selected using convenience and purposive sampling The feasibility will be assessed through adherence rates using the Exercise Adherence Scale and Sport Injury Rehabilitation Adherence Scale along with usability evaluations using the Visual Analogue Scale Patient Specific Functional Scale and the Knee Injury and Osteoarthritis Outcome Score Exercises in the program target strengthening of key muscle groups including quadriceps hamstrings core and gluteal muscles The program is tailored based on each participants pain level and tolerance
The goal is to understand whether a remote structured audiovisual intervention can serve as a feasible alternative to in clinic physiotherapy for knee osteoarthritis patients in India The study will also explore exercise adherence usability of the delivery method and overall patient outcomes |