Data

My Knee Exercise Nelligan 2021

The University of Melbourne

Dataset description

Demographic, baseline and 24-week follow-up data from the My Knee Exercise trial. 206 patients aged over 45 years who met clinical criteria for knee osteoarthritis. The control group (n = 103) was given access to a custom-built website with information on OA and the importance of exercise and physical activity. The intervention group (n = 103) was given access to the same information plus a prescription for a 24-week self-directed strengthening regimen and guidance to increase physical activity, supported by automated behavior-change text messages encouraging exercise adherence. All data presented in the results paper (JAMA Intern Med. 2021;181(6):776-785) available in XLSX format.
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Source Study

Purpose

Treatment

Phase

Not Applicable

Funding

Government body,Australian Government Research Training Program (RTP) Scholarship.

Scientific enquiries

Prof Kim Louise Bennell

Brief Summary

Knee osteoarthritis (KOA) is a leading contributor to burden of disease in Australia. Pain and impaired function are characteristic symptoms leading to physical disability, inactivity and reduced quality of life all of which further perpetuate functional decline. Guidance to facilitate self-management is key in the treatment of KOA with physical activity and exercise advocated by all clinical guidelines as the cornerstone of conservative management irrespective of disease severity. Unfortunately ....
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Key Inclusion Criteria

a) Meet the National Institute for Health and Care Excellence (NICE) osteoarthritis clinical criteria: - aged 45 years and over - activity related knee joint pain - morning stiffness of 30 minutes or less; b) History of knee pain on most days for 3 months or more; c) Overall average knee pain in past week self-rated as equal to or greater than 4 out of 10 on an 11-point numeric rating scale (NRS); d) Able to give informed consent and to participate fully in the interventions and assessment proce ....
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Key Exclusion Criteria

· Booked for knee joint replacement surgery; · Have had a knee joint replacement in the most painful knee; · Have participated in a structured knee exercise program within the past 6 months; · Self-reported diagnosis of rheumatoid arthritis or other inflammatory arthritis; · Have had a fall within the last 12 months and do not receive clearance from a General Practitioner to participate in an unsupervised home exercise program; · Are housebound requiring assistance from another person to leave t ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    206

Min. age    45 Years

Max. age    No limit

Sex    Both males and females

Condition category    Chronic Knee Pain , Osteoarthritis

Condition code    Musculoskeletal

Intervention

Intervention code Rehabilitation

My Knee Exercise Intervention Participants will be provided a URL to access “My Knee Exercise”, a website containing information to assist in the self-management of knee pain. Over 24 weeks they will be asked to access the website at home, on their own device, read the educational information provided and complete a self-directed, home-based, exercise program. Participants can view the website as often as they require. Specifically, they will be asked to access the 4 website sections. All sectio ....
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Comparison

Control group Active

Participants will be provided a URL to access “My Knee Education”, a website containing only the My Knee Education section of the My Knee Exercise website (intervention). The material provided has been specifically developed for this study. General exercise and physical activity recommendations will also be provided, similar to those available in current Internet-based Australian OA consumers resources. Over 24 weeks they will be asked to access the website at home, on their own device, read the ....
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Outcomes

Outcome: Average overall knee pain severity in past week using a Numeric Rating Scale (NRS)
Timepoint: Baseline and 24 weeks after intervention commencement (primary time-point)

Outcome: The physical function sub-scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be extracted from the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire.
Timepoint: Baseline and 24 weeks after intervention commencement (primary time-point)

Study Protocol: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

All data presented in the results paper (JAMA Intern Med. 2021;181(6):776-785) available in XLSX format.

When will data be available?

12-04-2021 to 12-04-2036 (a period of 15 years from publication)

Available to whom?

Data will be made available as required for specific, approved analyses by researchers. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.

Available for what types of analyses?

The investigators endorse the concept of data sharing to advance medical science. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner. Analyses aimed to improve treatment of knee osteoarthritis for non-commercial purposes are eligible.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au