Knee OsteoarthritisOPENNCT01608282
Internet Intervention to Improve Physical Activity in Early Knee Osteoarthritis
A study testing OPEN website in people with Knee Osteoarthritis, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- OPEN website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Capitalizing on the Teachable Moment: the OPEN (Osteoarthritis Physical Activity & Exercise Net) for Improving Physical Activity in Early Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- OPEN website
- Keywords
- Osteoarthritis, Arthritis, Knee, Exercise, Physical Activity, Web-based
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Arthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPEN websiteBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| OPEN Intervention Group | Experimental | 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. Receives: Behavioral: OPEN website |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline in levels of physical activity at 3 months and 6 months
Secondary outcomes (3)
Knee Injury and OA Outcome Score (KOOS).
The KOOS consists of five subscales: knee pain, stiffness, daily activity, sports/recreation, and quality of life.
Measured: Change from baseline in knee pain, stiffness, daily activity, sports/recreation and quality of life at 3 months and 6 months
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.
Measured: Change from baseline in motivation for physical activity at 3 months and 6 months
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.
Measured: Change from baseline in aerobic fitness at 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2015
- Study completionMay 2015
Why it stopped: Unable to reach recruitment target
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Simon Fraser University, Arthritis Research Centre of Canada
- Responsible party
- Principal investigator, Linda Li, University of British Columbia
- Investigators
- Linda Li, PhD, Principal investigator, University of British Columbia and Arthritis Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608282
- Sponsor's protocol ID
- H12-00493
- Acronym
- OPEN
- Status last verified
- Jun 2017
- First submitted
- 25 May 2012
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23659903
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capitalizing on the Teachable Moment: the OPEN (Osteoarthritis Physical Activity & Exercise Net) for Improving Physical Activity in Early Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01608282
- Acronym / sponsor ID
- OPEN / H12-00493
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Arthritis, Knee, Exercise, Physical Activity, Web-based
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to reach recruitment target
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Simon Fraser University, Arthritis Research Centre of Canada
- Study start
- Oct 2012 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 31 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPEN Intervention Group | Experimental | Behavioral: OPEN websiteIntervention 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 | No intervention | –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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPEN websiteThe 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 | Behavioural | OPEN Intervention Group |
Primary outcome
Modified Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ).
Time frame: Change from baseline in levels of physical activity at 3 months and 6 months
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).
3 secondary outcomes
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
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
Aerobic fitness (V02Peak)
Time frame: Change from baseline in aerobic fitness at 3 months and 6 months
Results and safety
The study was stopped early (reason given: Unable to reach recruitment target). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Derived from this study: PubMed 23659903Li 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.
- OPEN project - Arthritis Research Centre of CanadaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Li, PhD principal investigator
University of British Columbia and Arthritis Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPEN website in people with Knee Osteoarthritis, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to reach recruitment target). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ). (time frame: Change from baseline in levels of physical activity at 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01608282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.