Effectiveness of blended web-based rehabilitation on measures of pain, functionality and physical activity of patients with knee osteoarthritis: study protocol for a randomized control trial
| ISRCTN | ISRCTN12950684 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12950684 |
| Secondary identifying numbers | 49238/09-07-2020 |
- Submission date
- 17/09/2020
- Registration date
- 27/09/2020
- Last edited
- 08/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Education and exercise have been recommended for patients with knee osteoarthritis (OA). However, due to the chronic nature of pain of knee OA as well as the difficulty in access to health services, patients would benefit from a self-managed programme that encourages physical activity.
Who can participate?
Patients with knee OA, with no cognitive issues
What does the study involve?
It involves a web-based rehabilitation programme (combining both behavioural and exercise components) as well as suggested specified walk journeys within their municipality.
What are the potential benefits and risks of participating?
Patients would learn how to manage their pain with confidence and be more physically active. No real risks associated, apart from the discomfort that might arise after undertaking an exercise programme lasting for 2-3 days.
Where is the study run from?
University of West Attica (Greece)
When is the study starting and how long is it expected to run for?
February 2020 to February 2022
Who is funding the study?
State Foundation Scholarship (IKY) (Greece)
Who is the main contact?
Maria Moutzouri
Contact information
Scientific
Agiou Spiridonos 28
Egaleo
12243
Greece
 ORCID ID |
0000-0002-7014-892X |
|---|---|
| Phone | +30 (0)6977073125 |
| moutzouri@uniwa.gr |
Study information
| Study design | Double-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | Not available in web format. please use contact details to request a participant information sheet. |
| Scientific title | Effectiveness of blended web-based rehabilitation enhanced with outdoor structured walking-based activity on measures of pain, functionality and physical activity of patients with knee osteoarthritis: study protocol for a randomised control trial |
| Study acronym | Webphys |
| Study objectives | Web-based rehabilitation is superior to monitored physical activity in pain levels and functionality in patients with knee osteoarthritis. |
| Ethics approval(s) | 1. Approved 20/07/2020, University of West Attica Research Ethics Committe (agiou spiridonos 28, Aegaleo, 12243, Greece; +30 210-5387.294; ethics@uniwa.gr), ref: 52650 - 20/07/2020 2. Approved 20/07/2020, Research Ethics Committee of the University of West Attica (Ag Spiridonos, Egaleo, PC 12243, Greece; +30 3105387294; ethics@uniwa.gr), ref: 49238/09-07-20 |
| Health condition(s) or problem(s) studied | Knee osteoarthritis |
| Intervention | Group 1: This group will undertake 6 weeks of exercise, twice a week, by watching videotaped sessions and once a week attend an informative behavioural video session on how to manage pain. Group 2: This group will follow specified, mapped green journeys by walking twice a week. Group 3 (control): This group will receive a booklet with examples of exercise and information on how to manage pain and encouragement to increase physical activity. Randomisation is done via a computer-generated excel file. The interventions will last for 6 weeks, and we will assess patients at baseline, 6 weeks and 3 months. |
| Intervention type | Behavioural |
| Primary outcome measure | Self-reported functionality measured by KOOS at baseline, 6 weeks and 3 months |
| Secondary outcome measures | Functionality measured by Timed Up and Go Test at baseline, 6 weeks and 3 months |
| Overall study start date | 16/02/2020 |
| Completion date | 16/02/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 45 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 44 |
| Key inclusion criteria | Citizens of the municipalities of West Attica in Athens, aged between 45 and 75 years with knee osteoarthritis |
| Key exclusion criteria | Participants with musculoskeletal injury or surgery in the lower limbs, participants with cardiovascular problems, particpants with neurological disorders. |
| Date of first enrolment | 02/11/2020 |
| Date of final enrolment | 20/10/2021 |
Locations
Countries of recruitment
- Greece
Study participating centres
Paraskeuopoulou 23
Peristeri
Athens
12132
Greece
Egaelo
Athens
12243
Greece
Sponsor information
University/education
Egaleo Park
Athens
12243
Greece
| Phone | +30 210 5387475 |
|---|---|
| gioftsos@uniwa.gr | |
| Website | http://www.uniwa.gr/en/ |
"ROR" |
https://ror.org/00r2r5k05 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 16/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Planned publication in a high-impact peer-reviewed journal. 2. Participants desiring to know the outcomes of the study will be informed by email. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 26/05/2022 | 27/05/2022 | Yes | No | |
| Results article | 06/02/2024 | 08/03/2024 | Yes | No |
Editorial Notes
08/03/2024: Publication reference added.
12/09/2023: Ethics approval details added. The intention to publish date was changed from 16/03/2023 to 16/12/2023.
10/02/2023: The intention to publish date was changed from 16/02/2023 to 16/03/2023.
27/05/2022: Publication reference added.
14/10/2021: The total final enrolment number has been added.
26/08/2021: The following changes have been made:
1. The public title has been changed from "Telerehabilitation versus monitored increased physical activity on pain and functionality of patients with knee osteoarthritis" to "Effectiveness of blended web-based rehabilitation on measures of pain, functionality and physical activity of patients with knee osteoarthritis: study protocol for a randomized control trial".
2. The scientific title has been changed from "The effects of self-managed web-based rehabilitation versus monitored physical activity on levels of pain, functionality and quality of life in patients with knee osteoarthritis" to "Effectiveness of blended web-based rehabilitation enhanced with outdoor structured walking-based activity on measures of pain, functionality and physical activity of patients with knee osteoarthritis: study protocol for a randomised control trial".
09/06/2021: The recruitment end date has been changed from 20/06/2021 to 20/10/2021.
25/09/2020: Trial’s existence confirmed by University of West Attica.
