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

Primary Purpose

Knee Osteoarthritis

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
OPEN website
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Arthritis, Knee, Exercise, Physical Activity, Web-based

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Arthritis Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

OPEN Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Knee Injury and OA Outcome Score (KOOS).
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
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)
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.

Full Information

First Posted
May 25, 2012
Last Updated
June 27, 2017
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Simon Fraser University, Arthritis Research Centre of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01608282
Brief Title
Internet Intervention to Improve Physical Activity in Early Knee Osteoarthritis
Acronym
OPEN
Official Title
Capitalizing on the Teachable Moment: the OPEN (Osteoarthritis Physical Activity & Exercise Net) for Improving Physical Activity in Early Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Unable to reach recruitment target
Study Start Date
October 2012 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Simon Fraser University, Arthritis Research Centre of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, Arthritis, Knee, Exercise, Physical Activity, Web-based

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPEN Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
OPEN website
Intervention Description
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
Primary Outcome Measure Information:
Title
Modified Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ).
Description
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).
Time Frame
Change from baseline in levels of physical activity at 3 months and 6 months
Secondary Outcome Measure Information:
Title
Knee Injury and OA Outcome Score (KOOS).
Description
The KOOS consists of five subscales: knee pain, stiffness, daily activity, sports/recreation, and quality of life.
Time Frame
Change from baseline in knee pain, stiffness, daily activity, sports/recreation and quality of life at 3 months and 6 months
Title
Rhode's 7-point Likert-type Theory of Planned Behaviour questionnaire
Description
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.
Time Frame
Change from baseline in motivation for physical activity at 3 months and 6 months
Title
Aerobic fitness (V02Peak)
Description
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.
Time Frame
Change from baseline in aerobic fitness at 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Li, PhD
Organizational Affiliation
University of British Columbia and Arthritis Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthritis Research Centre
City
Richmond
State/Province
British Columbia
ZIP/Postal Code
V6X 2C7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23659903
Citation
Li LC, Lineker S, Cibere J, Crooks VA, Jones CA, Kopec JA, Lear SA, Pencharz J, Rhodes RE, Esdaile JM. Capitalizing on the teachable moment: osteoarthritis physical activity and exercise net for improving physical activity in early knee osteoarthritis. JMIR Res Protoc. 2013 May 9;2(1):e17. doi: 10.2196/resprot.2553.
Results Reference
derived
Links:
URL
http://www.arthritisresearch.ca/top-menu-research-current/research-current/274-osteoarthritis-physical-activity-a-exercise-net.html?catid=64%3Aoa-current-research
Description
OPEN project - Arthritis Research Centre of Canada

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Internet Intervention to Improve Physical Activity in Early Knee Osteoarthritis

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