Effects of therapist-monitored high and low dose home exercise program in patients with knee osteoarthritis
| ISRCTN | ISRCTN10231069 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10231069 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | DYPCPT/IEC/40/2022 |
| Sponsor | Dr. D.Y. Patil Vidyapeeth, Pune |
| Funder | Dr. D.Y. Patil Vidyapeeth, Pune |
- Submission date
- 26/09/2025
- Registration date
- 02/02/2026
- Last edited
- 02/02/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
The current study aimed to compare the effectiveness of therapist-monitored low versus high dose home exercise program (lo-hi dose protocol) in patients with knee osteoarthritis (OA). This is a randomly allocated study that will compare the effectiveness of low-dose and high-dose home exercise programs against a control group receiving usual care, focusing on pain, function, quadriceps muscle strength, and physical performance in patients with knee osteoarthritis.
Who can participate?
Patients aged 50 years and older with knee osteoarthritis.
What does the study involve?
This study will compare [hi vs low vs control home exercise program] to see which is more effective in terms of pain intensity, physical function, physical performance, and sleep quality after 8 weeks of intervention. After baseline assessment, participants will be randomly allocated to three groups: low intensity exercise (Low dose), high intensity exercise (high dose) or usual care (control) groups. In the low-dose and high-dose exercise group, participants will perform an 8-week therapist-monitored individualized home exercise, two sessions per day, 5 days a week. The untreated control group only receive patient education about energy conservation and joint protection techniques.
What are the possible benefits and risks of participating?
Participants will receive a therapist-monitored home exercise program, which will help them manage their pain and improve physical function. There is no known risk because the program will be individualized and monitored by experienced therapists.
Where is the study run from?
Dr. D.Y. Patil Vidyapeeth, Pune, College of Physiotherapy, India.
When is the study starting and how long is it expected to run for?
February 2022 to June 2024
Who is funding the study?
Dr. D.Y. Patil Vidyapeeth, Pune, India.
Who is the main Contact:
Dr Tushar J Palekar, principal.physio@dpu.edu.in
Contact information
Principal investigator
Dr D Y Patil College of Physiotherapy, Plot no. BGP/190, Near Pavna Industries, Midc Area, Bhosari
Pune
411026
India
 ORCID ID |
0000-0001-9931-4023 |
|---|---|
| Phone | +91 020-9922154359 |
| principal.physio@dpu.edu.in |
Scientific
BC516, Block C, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Kowloon
0000
Hong Kong
| ORCID ID |
0000-0003-3187-8062 |
|---|---|
| Phone | +85227666711 |
| shah-nawaz.anwer@polyu.edu.hk |
Public
Dr D Y Patil College of Physiotherapy, Plot no. BGP/190, Near Pavna Industries, Midc Area, Bhosari
Pune
411026
India
| ORCID ID |
0000-0002-4912-8596 |
|---|---|
| Phone | +91 020-27805888 |
| mrudula.sangaonkar@dpu.edu.in |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind randomized clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of therapist monitored low versus high dose home exercise program in patients with knee osteoarthritis: a randomized controlled trial (Lo-HI dose trial) |
| Study acronym | Lo-Hi dose trial |
| Study objectives | The goal of this clinical trial is to learn if a high or low dose of home exercise is effective in managing people with knee osteoarthritis. |
| Ethics approval(s) |
Approved 26/04/2022, The Institutional Ethics committee of Dr D Y Patil College of Physiotherapy (Plot no. BGP/190, Near Pavna Industries, Midc Area, Bhosari, Pune, 411026, India; +91 20 6410 8555; rrbhonde@gmail.com), ref: DYPCPT/IEC/40/2022 |
| Health condition(s) or problem(s) studied | Knee osteoarthritis |
| Intervention | Researchers will compare [hi vs low vs control home exercise program] to see which is more effective in terms of pain intensity, physical function, physical performance, and sleep quality after 8 weeks of intervention. After baseline assessment, participants were randomly allocated to three groups: low-intensity exercise (low dose), high-intensity exercise (high dose) or usual care (control) groups. In the low-dose exercise group, participants performed following exercises for two sessions per day or as pain-tolerated: 1) walking for 10 minutes 2) straight leg raising exercise (SLR) for one set of 10 repetitions; 3) single leg standing (SLS) for one set of 10 repetitions; 4) semi squat for one set of 10 repetitions; 5) seated knee extension exercise for one set of 10 repetitions; 6) bilateral hip abduction and adduction exercise, for one set of 10 repetitions; and 7) self-stretching of quadriceps and hamstrings for one set of 10 repetitions. In the high-dose exercise group, participants performed the same exercise program with an increased number of sets (e.g., 2-3 sets) and repetitions (15-20 repetitions) for a longer duration. The untreated usual care control group received only patient education regarding energy conservation and joint protection techniques as outlined in the Mayo Clinic Booklet during the trial. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Pain intensity was measured using a visual analogue scale (VAS) at baseline and week 8 |
| Key secondary outcome measure(s) |
1. Physical Performance was measured using the 30-second chair stand test (30sCST) at baseline and week 8 |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 81 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Aged 50 and older 2. Symptomatic knee osteoarthritis diagnosed with grade ≥ 2 OA using the Kellgren-Lawrence severity scale 3. Having knee pain ≥ 2 on a VAS in the past week |
| Key exclusion criteria | 1. Neurological disorders 2. Implanted electrical devices 3. Non-ambulatory status 4. Significant cognitive impairment 5. Systemic inflammatory arthritis (e.g., gout) 6. A history of hip or knee replacement surgery, trauma or surgical arthroscopy of either knee within the last 6 months 7. Prior involvement in a similar study 8. Participation in an exercise program within the last 6 months 9. Intra-articular knee injection within the last 3 months 10. Anticoagulant therapy 11. Recent or imminent surgery (within 3 months), or medical co-morbidities that would preclude participation in exercises |
| Date of first enrolment | 02/05/2022 |
| Date of final enrolment | 30/04/2024 |
Locations
Countries of recruitment
- India
Study participating centre
Pune
411026
India
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Tushar J Palekar, principal.physio@dpu.edu.in. Anonymized individual participant data can be accessed. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/10/2025: Study's existence confirmed by the Dr D Y Patil College of Physiotherapy Institutional Ethics Committee, India.
