Internet Intervention to Improve Physical Activity in Early Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

— OPEN  

Official title:

Capitalizing on the Teachable Moment: the OPEN (Osteoarthritis Physical Activity & Exercise Net) for Improving Physical Activity in Early Knee Osteoarthritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01608282
• Other study ID #: H12-00493
• Status: Terminated
• Phase: N/A
• First received: May 25, 2012
• Last updated: June 27, 2017
• Start date: October 2012
• Est. completion date: May 2015

Study information

• Verified date: June 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

OPEN (Osteoarthritis Physical Activity and Exercise Net) is a website created based on a well developed behavioural theory. This intervention is developed for people with early knee osteoarthritis (OA) who have been sedentary. The investigators aim to engage these individuals to become physically active at a time when their joint symptoms tend to be mild. The primary goal of this proof-of-concept randomized controlled trial is to determine if the OPEN website plus an information pamphlet about OA will improve participation in physical activity in persons with early knee OA, compared to those who receive only the pamphlet.

Description:

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 OA and those with a diagnosis of knee OA with no contraindication for being physically active? 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 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 will be stratified by OA diagnosis (having previously undiagnosed OA, as identified by a validated questionnaire, versus having a knee OA diagnosis). participants from Metro Vancouver who have previously undiagnosed knee OA 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Have felt pain/discomfort in or around the knee during the previous year that lasted more than 28 separate or consecutive days.

• Are 50 years or older.

• Have not been physically active regularly (meaning, you have not participated in moderate intensity activities more than 90 minutes a week) in the past six months.

• Have access to the internet.

• Live in British Columbia.

Exclusion Criteria:

• Have physician diagnosis of rheumatoid arthritis, psoriatic arthritis, gout, ankylosing spondylitis, polymyalgia rheumatica, connective tissue diseases or fibromyalgia.

• Have a history of using disease-modifying anti-rheumatic drugs (DMARD) or gout medications.

• Have had total knee replacement surgery or currently being considered for.

• Have had any knee surgery within the past four months.

• Have had acute injury to the knee in the past six months.

• Have been using medication that may impair physical activity tolerance (e.g., beta blockers)

• Are at other risks from exercising as identified by the Physical Activity Readiness Questionnaire (PAR-Q)

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Canada	Arthritis Research Centre	Richmond	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of British Columbia	Arthritis Research Centre of Canada, Canadian Institutes of Health Research (CIHR), Simon Fraser University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ).	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).	Change from baseline in levels of physical activity at 3 months and 6 months
Secondary	Knee Injury and OA Outcome Score (KOOS).	The KOOS consists of five subscales: knee pain, stiffness, daily activity, sports/recreation, and quality of life.	Change from baseline in knee pain, stiffness, daily activity, sports/recreation and quality of life at 3 months and 6 months
Secondary	Rhode's 7-point Likert-type Theory of Planned Behaviour questionnaire	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.	Change from baseline in motivation for physical activity at 3 months and 6 months
Secondary	Aerobic fitness (V02Peak)	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.	Change from baseline in aerobic fitness at 3 months and 6 months