The effectiveness of E-health rehabilitation for patients with knee osteoarthritis
| ISRCTN | ISRCTN28185135 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28185135 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Scientific Research Committee of Al-Baha Health Cluster |
| Funder | Investigator initiated and funded |
- Submission date
- 31/10/2025
- Registration date
- 04/11/2025
- Last edited
- 05/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This study aims to test whether a telerehabilitation program using a smartphone app can improve muscle strength, pain, physical performance, and adherence to exercise among people with knee osteoarthritis (KOA). Traditional home exercise programs are effective but often suffer from poor long-term adherence. Using technology like a smartphone app may help patients follow their programs more consistently through video demonstrations, reminders, and therapist communication.
Who can participate?
Adults aged 40–70 years who have been diagnosed with grade II or III knee osteoarthritis for at least 6 months, have mild to moderate pain (rated 4–7 on a 0–10 scale), can walk without assistance, can read Arabic, and can use a smartphone.
What does the study involve?
Participants will be randomly assigned to one of two groups:
App-based group: Use a smartphone application providing resistance exercises with videos, reminders, and therapist feedback.
Paper-based group: Receive the same exercises in a printed booklet.
Both groups will perform the exercises three times per week for 6 weeks. Assessments will take place before and after the 6-week program, including tests for pain, muscle strength, physical function, and exercise adherence.
What are the possible benefits and risks of participating?
Participants may experience less pain, stronger muscles, better physical performance, and improved confidence in managing their condition. Risks are minimal but may include temporary discomfort or muscle soreness after exercise.
Where is the study run from?
The study will be conducted at Al-Aqiq General Hospital in Al-Baha, Saudi Arabia.
When is the study starting and how long is it expected to run for?
December 2024 to June 2026
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Rawan Aldhabi, raldhabi@kau.edu.sa
Contact information
Principal investigator
Department of Physical Therapy
Faculty of Medical Rehabilitation Sciences
King Abdulaziz University
PO Box 80324
Jeddah
21589
Saudi Arabia
 ORCID ID |
0009-0003-1178-7515 |
|---|---|
| raldhabi@kau.edu.sa |
Scientific
Department of Physical Therapy
Faculty of Medical Rehabilitation Sciences
King Abdulaziz University
PO Box 80324
Jeddah
21589
Saudi Arabia
| ORCID ID |
0000-0002-8126-1186 |
|---|---|
| malbadi@kau.edu.sa |
Public
Physical Therapy
Al Aqiq General Hospital
Albaha
65779
Saudi Arabia
| Shuruqazhar@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | interventional single-blinded randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effectiveness of telerehabilitation-based resistance exercise using a smartphone application in improving muscle strength, pain, physical performance, and adherence among patients with knee osteoarthritis: a randomized controlled trial |
| Study objectives | Principal Objective: To evaluate the effectiveness of telerehabilitation-based resistance exercises delivered through a smartphone app compared to paper-based exercises in improving muscle strength, pain, physical performance, and adherence in patients with knee osteoarthritis. Hypotheses: 1. The smartphone app–based telerehabilitation program will lead to greater improvements in muscle strength compared to the paper-based program. 2. The app-based program will reduce pain and improve physical performance more effectively. 3. The app-based program will enhance adherence to exercise by increasing self-efficacy and motivation. |
| Ethics approval(s) |
Approved 09/12/2024, Scientific Research Committee at Albaha Health Cluster (6720 South Road, Building 3716, Albaha, 65784, Saudi Arabia; +966 (0)114579300; info@shc.gov.sa), ref: KFH/IRB0901202024/7 |
| Health condition(s) or problem(s) studied | Knee osteoarthritis (KOA) |
| Intervention | Participants eligible for the study will be randomly assigned in a 1:1 ratio to either the intervention group (app-based home exercise program) or the control group (paper-based home exercise program) using a computer-generated block randomization method with variable block sizes to ensure balanced allocation. Allocation will be concealed using sequentially numbered, opaque sealed envelopes prepared by an independent researcher. App-based group: Use a smartphone application providing resistance exercises with videos, reminders, and therapist feedback. Paper-based group: Receive the same exercises in a printed booklet. Both groups will perform the exercises three times per week for 6 weeks. Assessments will take place before and after the 6-week program, including tests for pain, muscle strength, physical function, and exercise adherence. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Pain is measured using the Arabic Numeric Pain Rating Scale (ANPRS) at baseline and 6 weeks post-intervention |
| Key secondary outcome measure(s) |
1. Exercise adherence is measured using a self-reported exercise logbook, with adherence ratio calculated weekly over 6 weeks |
| Completion date | 01/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Adults aged 40–70 years 2. Diagnosed with mild-to-moderate KOA 3. Able to use a smartphone 4. Able to perform resistance exercises independently |
| Key exclusion criteria | 1. Severe KOA or knee surgery in the past 6 months 2. Neurological or musculoskeletal disorders affecting lower limbs 3. Cognitive impairment or inability to follow instructions |
| Date of first enrolment | 15/11/2025 |
| Date of final enrolment | 01/03/2026 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Albaha
65779
Saudi Arabia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Individual participant data (IPD) that underlie the results reported in this study will be made available upon reasonable request from the Principal Investigator (Dr Rawan Aldhabi; Raldhabi@kau.edu.sa) |
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
05/11/2025: The sponsor details were changed.
31/12/2025: Study's existence confirmed by the Scientific Research Committee at Albaha Health Cluster.
