Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Maria Moutzouri
ORCID ID
https://orcid.org/0000-0002-7014-892X
Contact details
Agiou Spiridonos 28
Egaleo
12243
Greece
+30 (0)6977073125
moutzouri@uniwa.gr
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
49238/09-07-2020
Study information
Scientific title
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
Acronym
Webphys
Study hypothesis
Web-based rehabilitation is superior to monitored physical activity in pain levels and functionality in patients with knee osteoarthritis.
Ethics approval
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
Study design
Double-blind randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Quality of life
Patient information sheet
Not available in web format. please use contact details to request a participant information sheet.
Condition
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
Phase
Drug names
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 trial start date
16/02/2020
Overall trial end date
16/02/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Citizens of the municipalities of West Attica in Athens, aged between 45 and 75 with knee osteoarthritis
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
Participants with musculoskeletal injury or surgery in the lower limbs, participants with cardiovascular problems, particpants with neurological disorders.
Recruitment start date
02/11/2020
Recruitment end date
20/06/2021
Locations
Countries of recruitment
Greece
Trial participating centre
Municipalities of West Attica, Peristeri and Egaleo
Kep Ygeias Peristeriou
Paraskeuopoulou 23
Peristeri
Athens
12132
Greece
Trial participating centre
University of West Attica
Agiou Spyridonos 28
Egaelo
Athens
12243
Greece
Sponsor information
Organisation
University of West Attica
Sponsor details
Egaleo Park
Athens
12243
Greece
+30 210 5387475
gioftsos@uniwa.gr
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
State Scholarship Foundation (IKY)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
16/02/2023
Participant level data
Available on request
Basic results (scientific)
Publication list