Condition category
Musculoskeletal Diseases
Date applied
17/09/2020
Date assigned
27/09/2020
Last edited
25/09/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

http://westwalks.uniwa.gr/

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

http://www.uniwa.gr/en/

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

Publication citations

Additional files

Editorial Notes

25/09/2020: Trial’s existence confirmed by University of West Attica.