Internet Intervention to Improve Physical Activity in Early Knee Osteoarthritis (OPEN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of British Columbia
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Simon Fraser University
Arthritis Research Centre of Canada
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01608282
First received: May 25, 2012
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Behavioral: OPEN website
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 252
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)
Arms Assigned Interventions
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.

Detailed 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 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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  • Are available for the follow-up assessments in the next 6 months.

Exclusion Criteria:

  • Have previous physician diagnosis of osteoarthritis, 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.
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608282

Contacts
Contact: Linda Li, PhD 604-871-4577 lli@arthritisresearch.ca
Contact: Charlene Yousefi, MPP 604-871-4572 cyousefi@arthritisresearch.ca

Locations
Canada, British Columbia
Arthritis Research Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1L7
Contact: Linda Li, PhD    6048714577    lli@arthritisresearch.ca   
Contact: Charlene Yousefi, MA    6048714572    cyousefi@arthritisresearch.ca   
Principal Investigator: Linda Li, PhD         
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Simon Fraser University
Arthritis Research Centre of Canada
Investigators
Principal Investigator: Linda Li, PhD University of British Columbia and Arthritis Research Centre
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01608282     History of Changes
Other Study ID Numbers: H12-00493
Study First Received: May 25, 2012
Last Updated: October 11, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Osteoarthritis
Arthritis
Knee
Exercise
Physical Activity
Web-based

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014