Internet Intervention to Improve Physical Activity in Early Knee Osteoarthritis

NCT01608282 | Terminated

• 1 other identifier: H12-00493
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Arthritis; Knee; Exercise; Physical Activity; Web-based

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Knee Injury and OA Outcome Score (KOOS).

  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

  Change from baseline in motivation for physical activity at 3 months and 6 months

• Aerobic fitness (V02Peak)

  Change from baseline in aerobic fitness at 3 months and 6 months

Study Arms (2)

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.

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.

Interventions

OPEN website BEHAVIORAL

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

OPEN Intervention Group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Simon Fraser University: collaborator
• Arthritis Research Centre of Canada: collaborator

Study Sites (1)

Arthritis Research Centre

Richmond, British Columbia, V6X 2C7, Canada

Location

Related Publications (1)

• 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.

  PMID: 23659903 DERIVED

Related Links

• OPEN project - Arthritis Research Centre of Canada

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Arthritis; Motor Activity

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Officials

• Linda Li, PhD

  University of British Columbia and Arthritis Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: May 31, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 29, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)