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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Research Unit for General Practice in Aalborg | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-managed exercise | Experimental |
| |
| Physiotherapist-supervised exercise | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-managed exercise in a fitness center | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain subscale of the KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaire | 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. | Change from baseline after 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health outcome and quality of life survey (EQ-5D-5L) | 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. | Change from baseline after 3 months |
| Patient Global Assessment of disease impact (PGA) |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesics usage | The participants' use of over-the-counter paracetamol and ibuprofen will be collected via questionnaire. Analgesics usage is recorded as a response to the questions "How often do you take pain relieving medicine* for your knee OA pain" with response options 1) Daily; 2) 2-3 times per week: 3) Rarer; or 4) Never. Responses 1 and 2 defines an analgesics user, whereas responses 3 and 4 defines a non-user. * A list of typical brand names will be provided. |
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marius Henriksen, Professor | Contact | 0045 38164155 | Marius.Henriksen@regionh.dk | |
| Camilla P Paulsen, Phd student | Contact | 0045 24854096 | Camilla.paludan.paulsen@regionh.dk |
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We will share the IPD, protocol and SAP, but the circumstances and timing has not been decided yet
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Supervised Exercise | Behavioral | 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. |
|
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". |
| Change from baseline after 3 months |
| KOOS Function subscale | 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. | Change from baseline after 3 months |
| KOOS quality of Life (QOL) subscale | 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 . | Change from baseline after 3 months |
| OMERACT-OARSI responder criteria | 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:
| 3 months |
| After 1, 2, 3, 4, 5, 6 months |
| Sleep Quality Single-item sleep quality scale (SQS) | Sleep quality will be obtained with the global Single-item sleep quality scale (SQS). | After 1, 2, 3, 4, 5, 6 months |
| Self-reported physical activity (UCLA activity scale) | Self-reported physical activity will be obtained with the University of California Loas Angeles activity scale (UCLA). UCLA is a single-item 10-level-scale, ranging from level 10, representing a highly physically active patient, to level 1, a patient who is dependent on others and unable to leave home. | After 1, 2, 3, 4, 5, 6 months |
| Out of pocket spending on knee OA - The cost for patients questionnaire (CoPaQ) | The cost for patients questionnaire (CoPaQ) is a comprehensive tool to measure direct and indirect out-of-pocket costs of a health condition for patients and their families to various outpatient contexts. | After 1, 2, 3, 4, 5, 6 months |
| The World Health Organization Five Well-Being Index (WHO-5) | Self-reported mental well-being will be obtained with the WHO5-Well-Being Index consisting of five questions. | After 1, 2, 3, 4, 5, 6 months |
| Body weight | Is recorded as kilograms and obtained self-reported via questionnaire | After 1, 2, 3, 4, 5, 6 months |
| The KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaire | The Knee injury and Osteoarthritis Outcome Score (KOOS) consists of 42 items covering five subscales (domains): 1) Pain; 2) Function; 3) Knee related quality of life; 4) Symptoms; 5) Sports and Recreation. The KOOS adopts a five-point Likert scale scoring system (ranging from 0 (least severe) to 4 (most severe)). A normalized score is calculated for each subscale (domain) with 100 indicating best score and 0 indicating the worst score. | After 1, 2, 3, 4, 5, 6 months |
| Health outcome and quality of life survey (EQ-5D-5L) | EQ-5D-5L is a standardized patient-reported instrument for use as a measure of health outcome and quality of life. | After 1, 2, 4, 5, 6 months |
| Patient Global Assessment of disease impact (PGA) | 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". | After 1, 2, 4, 5, 6 months |
| OMERACT-OARSI responder criteria | Number of treatment responders according to OMERACT-OARSI response criteria, following two conditions is observed at the post-baseline assessment: 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 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) | After 6 months |
| D012216 |
| Rheumatic Diseases |
| D001519 | Behavior |