Knee Osteoarthritis
Conditions
Keywords
Exercise
Brief summary
Knee osteoarthritis (OA) is a common painful condition associated with pain and disability. OA healthcare costs the Danish society 4.6 billion DKK more per year than the non-OA population and we lack evidence on how best to organize and deliver care to reduce costs. Recommended first line treatment for knee OA is exercise with proven effects on symptoms. The current paradigm assumes that exercise needs to be delivered and supervised by a physiotherapist which require patients to attend a clinic at specific times and geographical locations. This is an expensive model of care and creates barriers for people that are active on the labor market or lives in remote areas with long distances to the nearest clinic. In fact, the productivity loss in Denmark associated with OA is estimated to be 12.4 billion DKK per year. While effective on symptoms, the current model with supervised physiotherapy associates with significant shortcomings, and barriers related to patient heterogeneity, costs, accessibility, and work absenteeism. As an alternative, a local fitness center is far more accessible as these are widely dispersed across the country, are accessible daily (including weekends) at all hours, is cheap and offers a wide variety of exercise types, classes, and equipment to accommodate individual preferences. The cost of a fitness center membership is approximately 300 DKK per month and includes exercise ad libitum. In contrast, a typical physiotherapist-supervised exercise program costs 3-4,000 DKK for a 2-month treatment with 2 weekly sessions. Consequently, there is a need to investigate if self-managed exercise in a fitness center is cost-effective as first-line management of knee OA. To answer this question, the present trial aims to compare self-managed exercise in a fitness center to the current standard - supervised exercise. This has the potential to improve quality of care for people with knee OA by adding a cost-effective option for first line management of people with knee OA.
Interventions
BEHAVIORALSelf-managed exercise in a fitness center
The participants are offered a 6-month membership of a local fitness club at no cost (paid by the trial). They will receive an introduction to the fitness centre and receive instructions from a personal trainer in the centre to create a personalized exercise programme
BEHAVIORALSupervised Exercise
The particiopants are offered participation in the usual care exercise delivered at municipal rehabilitation centers or private physiotherapy clinics, aat the discretion of the referring doctor.
Sponsors
Marius Henriksen
University of Copenhagen
Research Unit for General Practice in Aalborg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Diagnosis of knee OA according to the NICE criteria: Adults aged 45 or over with activity-related joint pain and either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes.
Exclusion criteria
* Completion of a supervised therapeutic exercise program for knee OA within 3 months * Contraindication to exercise (e.g., resting systolic blood pressure \> 200 or diastolic blood pressure \>110 mmHg, acute or reoccurring chest pain, unstable angina. uncontrolled cardiac arrhythmias, decompensated heart failure. suspected or known dissecting aortic aneurysm) * Lack of independent mobility that requires aid for transportation to/from exercise facilities. * Any condition or impairment that, in the opinion of the recruiting GP, makes a potential participant unsuitable for participation or which may obstruct participation (e.g. psychiatric or cognitive disorders, language barriers, or opiate dependency).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain subscale of the KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaire | Change from baseline after 3 months | Assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale (patient-reported questionnaire). The KOOS pain subscale consists of 9 questions with a five-point Likert scale scoring system (ranging from 0 (least severe) to 4 (most severe)). The answers are summed and a 0-100 normalized score is calculated with 0 indicating extreme pain and 100 indicating no pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health outcome and quality of life survey (EQ-5D-5L) | Change from baseline after 3 months | EQ-5D-5L is a standardized patient-reported instrument for use as a measure of health outcome and quality of life. EQ-5D-5L is designed for self-completion by respondents and is ideally suited for use in surveys. |
| Patient Global Assessment of disease impact (PGA) | Change from baseline after 3 months | Patient-reported degree of patient's perceived impact of their knee OA on their overall life will be obtained using a 100 mm analogue scale (VAS) with anchors: 0=" No impact" and 100 = "Worst imaginable impact". |
| KOOS Function subscale | Change from baseline after 3 months | Assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) physical function subscale (patient-reported questionnaire). The KOOS physical function subscale consists of 17 questions with a five-point Likert scale scoring system (ranging from 0 (least severe) to 4 (most severe)). The answers are summed and a 0-100 normalized score is calculated with 0 indicating extreme functional impairment and 100 indicating no functional impairment. |
| KOOS quality of Life (QOL) subscale | Change from baseline after 3 months | Assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life subscale (patient-reported questionnaire) The KOOS knee related quality of life subscale consists of 4 questions with a five-point Likert scale scoring system (ranging from 0 (least severe) to 4 (most severe)). The answers are summed and a 0-100 normalized score is calculated with 0 indicating extremely poor knee related quality of life pain and 100 indicating very good knee related quality of life . |
| OMERACT-OARSI responder criteria | 3 months | Number of treatment responders according to the OMERACT-OARSI response criteria. A participant is classified as a responder if at least 1of the following 2 conditions is observed: 1. In either pain (KOOS pain subscale) or function (KOOS function subscale), a high improvement in the subscale, where high improvement in a subscale is achieved if there is both a \>50% improvement from Baseline and an absolute change from Baseline of \>20 points (0-100 scale), OR 2. Improvement in at least two of the following three: * Improvement in pain (KOOS pain subscale) defined as \>20% improvement from Baseline and an absolute change from Baseline of \>10 points (0-100 scale). * Improvement in function (KOOS function subscale) defined as \>20% improvement from Baseline and an absolute change from Baseline of \> 10 points (0-100 scale). * Improvement in patient's global assessment defined as \>20% improvement from Baseline and an absolute change from Baseline of \>10 mm (0-100 scale). |
Contacts
CONTACTMarius Henriksen, Professor
CONTACTCamilla P Paulsen, Phd student
Outcome results
None listed