| CTRI Number |
CTRI/2026/02/102716 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| 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
|
Comparison between the effect of calisthenic exercises and strengthening exercises in patients with osteoarthritis of knee |
|
Scientific Title of Study
|
Comparison Between the Effect of Calisthenic Exercises and Strengthening Exercises on Pain Range of Motion and Functional Mobility in Patients with Osteoarthritis of Knee: RCT |
| 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 Mansee Sanjay Dangare |
| Designation |
Master of Musculoskeletal Physiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy latur |
| Address |
Department of Musculoskeletal physiotherapy, OPD no 15, MIPT college, MIMSR Campus, Ambajogai Road Latur, 413531
Latur MAHARASHTRA 413531 India |
| Phone |
9325110071 |
| Fax |
|
| Email |
mansidangare217@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Risha Kamble |
| Designation |
Associate Professor of Musculoskeletal Physiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy latur |
| Address |
Department of Musculoskeletal physiotherapy, OPD no 15, MIPT college, MIMSR Campus, Ambajogai Road Latur, 413531
Latur MAHARASHTRA 413531 India |
| Phone |
9730857306 |
| Fax |
|
| Email |
rishakamble9@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Risha Kamble |
| Designation |
Associate Professor of Musculoskeletal Physiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy latur |
| Address |
Department of Musculoskeletal physiotherapy, OPD no 15, MIPT college, MIMSR Campus, Ambajogai Road Latur, 413531
Latur MAHARASHTRA 413531 India |
| Phone |
9730857306 |
| Fax |
|
| Email |
rishakamble9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Musculoskeletal Physiotherapy, Maharashtra Institute of Physiotherapy, MIMSR Campus, Ambajogai Road, Latur, Maharashtra, India 413531 |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Department of Musculoskeletal physiotherapy, OPD no 15, MIPT college, MIMSR Campus, Ambajogai Road Latur, Maharashtra, India 413531 |
| Type of Sponsor |
Private medical college |
|
|
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 Mansee Sanjay Dangare |
Maharashtra Institute of Physiotherapy Latur |
Department of Musculoskeletal physiotherapy, OPD no 15, MIPT college, MIMSR Campus, Ambajogai Road Latur, Maharashtra, India 413531 Latur MAHARASHTRA |
9325110071
mansidangare217@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1)Calisthenic exercises
2)Conventional Therapy |
1)Calisthenic exercises-Participants will receive low-intensity calisthenic exercises will be performed in 3 sets of 10 repetitions with 10-second hold, 3-second rest between repetitions and 3-minute rest between sets.
2)Conventional therapy- Moist heat pack, Interferential therapy |
| Comparator Agent |
1)Strengthening exercises
2)Conventional therapy |
1)Strengthening exercises-Participants will recieve strengthening exercises including isometric exercises and TheraBand resistance training, starting with low-resistance yellow bands for the first two weeks and progressing to higher-resistance red bands for the last two weeks as exercises become easier. The program will be given on alternate days and will include isometric muscle activation (3 sets of 12 repetitions with 5-second holds) followed by TheraBand exercises performed for 10 repetitions in three sets with 3 minutes rest between sets, within a pain-free range.
2)Conventional therapy- Moist heat pack, Interferential therapy |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with chronic osteoarthritis (symptoms more than 3 months).
2. Age group between 45-65 years.
3. Both male and female.
4. Grade II or III as per Kellgren and Lawrence radiographic classification.
5. Patients with unilateral knee osteoarthritis.
|
|
| ExclusionCriteria |
| Details |
1.Patients having systemic joint pathologies, inflammatory joint disease (e.g. rheumatoid arthritis, gouty arthritis, psoriatic arthritis).
2. Patients who had any neurological deficit (paresthesia, sensory loss, radiculopathy, myelopathy)
3. Patients with any mental illness (dementia, Parkinson’s, Alzheimer)
4. Any history of recent surgery to lower limb.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Visual analogue scale (VAS)
2. Range of motion (ROM) by Goniometer
3. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
|
Pre and Post Assessment at baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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)
|
12/02/2026 |
| 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="0" 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
|
This is a Randomized clinical trial Subjects will be included according to inclusion and exclusion. Inclusion criteria:- Patients with chronic osteoarthritis (symptoms more than 3 months), Age group between 45-65 years, Both male and female, Grade II or III as per Kellgren and Lawrence radiographic classification, Patients with unilateral knee osteoarthritis. Exclusion criteria:- Patients having systemic joint pathologies, inflammatory joint disease (e.g. rheumatoid arthritis, gouty arthritis, psoriatic arthritis), Patients who had any neurological deficit (paresthesia, sensory loss, radiculopathy, myelopathy), Patients with any mental illness (dementia, Parkinson’s, Alzheimer), Any history of recent surgery to lower limb. The entire procedure involved in this study will be explained to each subject. A written informed consent will be obtained from the participants. Demographic data of the participants will be collected. Patients will be assessed for visual analogue scale (VAS), Range of Motion (ROM), WOMAC scale pre and post to the intervention. Group A will receive calisthenic exercises with 3 sets of 10 repetitions, with 10-second hold performed for each exercise. There will be a pause of 3 seconds between repetitions and 3 minutes rest between the sets. The therapy will be given in alternate days. along with moist hot pack for 20 minutes over the knee joint, Interferential therapy for 20 to 30 minutes. Group B will receive strengthening exercises including isometric exercises and using TheraBand. The exercise will start with the less resistive bands (yellow band) then it was progress to the higher resistance exercise band (red band). As the exercises with resistive bands at one level will become easier to perform. Participants will be asking to progress to the level of exercise (exercise progression: yellow band in the first two weeks and red band in the last two weeks). 10 repetitions of each exercise in three sets with 3 minutes rest between sets. The therapy will be given on alternate days. |