| CTRI Number |
CTRI/2025/05/086722 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A community based trial to study the effectiveness of home based exercise program in rural older adults with knee osteoarthritis |
|
Scientific Title of Study
|
Effectiveness and feasibility of a home based exercise program for knee osteoarthritis: a quasi experimental implementation trial in rural older adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swetali Patro |
| Designation |
MPH Student |
| Affiliation |
Indian Institute of Public Health, Gandhinagar |
| Address |
Master of Public Health student, MPH 23055, 2023-2025 batch
NH-147, Palaj village, Opposite New Air Force Headquarters, Gandhinagar, Gujarat
Gandhinagar
GUJARAT
382042
India |
| Phone |
7008257877 |
| Fax |
|
| Email |
sdnpatro9525@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandul Yasobant |
| Designation |
Assistant Professor |
| Affiliation |
Indian Institute of Public Health, Gandhinagar |
| Address |
Department of Public Health Science,
Indian Institute of Public Health Gandhinagar
Gandhinagar
GUJARAT
382042
India |
| Phone |
9861357331 |
| Fax |
|
| Email |
yasobant@iiphg.org |
|
Details of Contact Person
Public Query
|
| Name |
Swetali Patro |
| Designation |
MPH Student |
| Affiliation |
IIPH Gandhinagar |
| Address |
Master of Public Health student, MPH 23055, 2023-2025 batch
NH-147, Palaj village, Opposite New Air Force Headquarters, Gandhinagar, Gujarat
Gandhinagar
GUJARAT
382042
India |
| Phone |
7008257877 |
| Fax |
|
| Email |
sdnpatro9525@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Institute of Public Health Gandhinagar
NH-147, Palaj Village, opp. New Air Force Station HQ, Gandhinagar, Gujarat 382042 |
| Model Rural Health Research Unit, Sheragada, Ganjam
opposite CHC Sheragada, 761106
functional under ICMR-Regional Medical Research Centre, Bhubaneswar 751023. |
|
|
Primary Sponsor
|
| Name |
Director, IIPH Gandhinagar |
| Address |
IIPH Gandhinagar, opp Air Force Headquarters, Lekawada, Gandhinagar, 382042 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MRHRU Sheragada |
CHC Sheragadam, Ganjam, Odisha |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Swetali Patro |
Primary Health Centre P.Karadakana |
P.Karadakana, Block Sheragada, Ganjam, Odisha, India,761106
Ganjam
ORISSA |
7008257877
sdnpatro9525@gmail.com |
| Swetali Patro |
Primary Health Centre, Gaudagaon, |
Dekhali Road, Gaudagaon, Odisha, India, 761011
Ganjam
ORISSA |
7008257877
sdnpatro9525@gmail.com |
| Swetali Patro |
Primary Health Centre, Sidheswar |
Sidheswar, Ganianala Square, Digapahandi Block, Ganjam, India, 761054
Ganjam
ORISSA |
7008257877
sdnpatro9525@gmail.com |
| Swetali Patro |
Primary Health Centre, Talasingi |
Talasingi, Block Digapahandi, Ganjam, Odisha, India, 761007
Ganjam
ORISSA |
7008257877
sdnpatro9525@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| ICMR-RMRC Bhubaneswar Academic Ethics Committee |
Approved |
| IIPH Gandhinagar- Institutional ethics Committee |
Approved |
| INDIAN INSTITUTE OF PUBLIC HEALTH GANDHINAGAR INSTITUTIONAL ETHICS COMMITTEE (IIPHG-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guided Rural Arthritis Care Through Exercise (GRACE) |
A multi component intervention to improve the adherence, pain levels and physical function in KOA patients has been designed based on consultation from experts along with literature review. Patients will receive an intervention package that includes an exercise diary for self- reporting, a pictorial guidebook with detailed instructions on home exercises (frequency, intensity, duration), a QR code leaflet with compiled exercise videos for guidance and a health education module covering information on KOA and the benefits of the home exercise program and an informational sheet on dos and don’ts for KOA management. The content of the health education module includes a wide range of knowledge related to KOA and exercise program (e.g., signs and symptoms, treatment options, benefits of the exercise. The intervention package will be developed in the regional language, Odia for better understanding by the participants. A set of home exercises will be recommended to increase the knee joint muscle strength without inducing knee stress. The developed regimen includes one stretching exercise, four strengthening exercises along with normal range of motion movements around the hip and knee joint with recommended dosage and frequency. During the exercise regimen the participant is recommended to perform the exercises for 5 sessions/week for 40 min (30 min plus 5-min warm-up and 5-min cool-down) with each exercise performed for 10 repetitions/set for 3 sets and a rest between each set as required before starting the next set. Each set will be performed bilaterally starting with the less affected limb. The set of exercises are isometric quadriceps, Supine Straight leg raise, Side-lying straight leg raise, seated leg lifts, hamstring stretch & active range of motion of knee. The intervention will continue for 3 months i.e. 12 weeks period |
| Comparator Agent |
Self comparator |
This is a pre-post quasi-experimental study where the comparison is made between the baseline and endline assessments within the intervention group. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Willingness to alter their lifestyle and follow up.
2. Clinically diagnosed cases of Knee Osteoarthritis by medical officer.
3. Having Knee pain from the past one year.
4. Non-deformed cases of Knee Osteoarthritis
5. Intact cognition
6. Not indicated for Total Knee Replacement.
7. Ability of the patient or caregiver to effectively use IT for communication. |
|
| ExclusionCriteria |
| Details |
1. Individuals with bowel or bladder incontinence
2. Individuals unable to sit, stand, walk due to severe medical or mobility problems.
3. Individuals unable to commit to the study requirements.
4.Individuals with an acute knee injury within 6 months.
5.Individuals having any sort of joint replacement surgery or arthroscopic surgery on the affected side of the knee.
6. Individuals having any major surgery in the last year or planning to undergo future surgeries.
7. Individuals having severe deformity in lower limbs.
8. No prior physiotherapy.
9. Non-compliance of study requirements or refusal of consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Exercise adherence to the structured home-based exercise program among older adults with non-deformed knee osteoarthritis, assessed over a 12-weekintervention period. |
baseline, 2nd week, 4th week, 6th week, 8th week, 10th week & 12th week. i.e. endline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain levels among the older adults with non deformed knee osteoarthritis— measured using a standardized pain assessment tool. |
Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week |
| Physical function & mobility among the older adults with non deformed knee osteoarthritis — measured using a standardized pain assessment tool. |
Baseline i.e. 0 weeks & endline i.e. 12 weeks along with at 4th week, 8th week & 12th week. |
| Feasibility outcomes of the intervention |
During baseline & after completion of the study. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/05/2025 |
| 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
|
Knee osteoarthritis (KOA) is a common cause of pain, disability, and reduced quality of life among older adults, especially in rural areas like Ganjam district of Odisha, where access to regular healthcare and physiotherapy is limited. Although exercise is a proven way to manage KOA, many elderly individuals struggle to stick to exercise routines, particularly when regular supervision is not available. This study aims to implement a simple, structured home-based exercise program for older adults with non-deformative KOA and assess how well they can follow it over a 12-week period. The focus will be on understanding how effective this program is in improving exercise adherence, reducing pain, and improving mobility and daily functioning. Additionally, the study will explore how practical and acceptable such a program is in areal-world rural setting. The results will help inform future community-based interventions to support older adults in managing KOA in resource-limited settings. |