Internet Intervention to Improve Physical Activity in Early Knee Osteoarthritis (OPEN)
Recruitment status was Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Capitalizing on the Teachable Moment: the OPEN (Osteoarthritis Physical Activity & Exercise Net) for Improving Physical Activity in Early Knee Osteoarthritis|
- Modified Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ). [ Time Frame: Change from baseline in levels of physical activity at 3 months and 6 months ] [ Designated as safety issue: No ]Proportion of participants meeting the American College of Sports Medicine physical activity recommendation of 150 minutes or more of weekly physical activity (moderate or heavy intensity).
- Knee Injury and OA Outcome Score (KOOS). [ Time Frame: Change from baseline in knee pain, stiffness, daily activity, sports/recreation and quality of life at 3 months and 6 months ] [ Designated as safety issue: No ]The KOOS consists of five subscales: knee pain, stiffness, daily activity, sports/recreation, and quality of life.
- Rhode's 7-point Likert-type Theory of Planned Behaviour questionnaire [ Time Frame: Change from baseline in motivation for physical activity at 3 months and 6 months ] [ Designated as safety issue: No ]Motivation for physical activity will be measured with Rhode's 7-point Likert-type Theory of Planned Behaviour (TPB) questionnaire. It consists of 16 items measuring all components of the TPB model, including behavioural, normative and control beliefs.
- Aerobic fitness (V02Peak) [ Time Frame: Change from baseline in aerobic fitness at 3 months and 6 months ] [ Designated as safety issue: No ]A sub-sample of participants (n=40) will undergo a submaximal aerobic fitness test at baseline, 3 months and 6 months. Aerobic fitness will be predicted by extrapolating the heart rate and oxygen update responses to three submaximal exercise stages.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: OPEN Intervention Group
Intervention group participants will receive an email prompt to access the OPEN website every two weeks for the first three months, with a short message about the ongoing projects at the Arthritis Research Centre of Canada. The OPEN website will remain accessible throughout the study, but no further prompting emails will be sent after Month 3. In addition, they will receive an education pamphlet produced by The Arthritis Society containing information about osteoarthritis, physical activity and other treatments.
Behavioral: OPEN website
The OPEN website includes interactive modules that allow users to prioritise their daily activities, set goals and find venues where they can participate in different types of activities according to their preferences and the local availability
No Intervention: Control Group
Control group participants will receive, by email, the same Arthritis Society pamphlet as the Intervention group. Participants will also receive, by email, the same short message about the ongoing projects at the Arthritis Research Centre of Canada, every two weeks for the first three months (i.e. the same schedule as the intervention group receiving the prompting email so that the number of contacts is equal in both groups), but without the prompting to use the OPEN website.
Being physically active has been shown to reduce pain, improve quality of life and potentially reduce joint damage. However, our recent survey in British Columbia found only 1 in 4 people with mild osteoarthritis symptoms (pain; stiffness) met the recommended level of physical activity. Research in people without arthritis shows that web-based tools can increase walking behaviour, but none of these tools are designed with the needs of people with arthritis in mind. Research in other chronic diseases has found that people are more likely to quit smoking shortly after the diagnosis of a smoking-related disease. Thus, the diagnosis of osteoarthritis presents an ideal 'teachable moment' to engage those who have been sedentary to become physically active.
This project will address the Research Question: Can an interactive website increase physical activity in people with previously undiagnosed knee osteoarthritis? We have created a website, called OPEN (Osteoarthritis Physical Activity & Exercise Net), based on a well developed behavioural theory. A total of 252 sedentary people with early knee osteoarthritis will be recruited in British Columbia to test the website. Half of them will be assigned to use the OPEN website for 3 months and will receive an education pamphlet produced by The Arthritis Society; the other half will only receive the pamphlet. During the test period, participants will complete an online questionnaire at 0, 3 and 6 months to allow us to follow changes in physical activity, knee symptoms and outcomes related to their motivation to become physically active. In addition, participants from Metro Vancouver will complete an aerobic fitness test administered by a blind assessor. Changes between the two groups will be compared.
Our project directly targets physical inactivity at a time when the joint damage tends to be mild, and when people are more motivated to adopt a healthy behaviour. If the OPEN is found to be effective in improving physical activity, it opens further opportunities to promote early diagnosis and to implement lifestyle interventions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608282
|Contact: Linda Li, PhDfirstname.lastname@example.org|
|Contact: Charlene Yousefi, MPPemail@example.com|
|Canada, British Columbia|
|Arthritis Research Centre||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 1L7|
|Contact: Linda Li, PhD 6048714577 firstname.lastname@example.org|
|Contact: Charlene Yousefi, MA 6048714572 email@example.com|
|Principal Investigator: Linda Li, PhD|
|Principal Investigator:||Linda Li, PhD||University of British Columbia and Arthritis Research Centre|