Self-managed vs Supervised Exercise for Knee OA
- Conditions
- Knee Osteoarthritis
- Registration Number
- NCT07210931
- Lead Sponsor
- Marius Henriksen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).