Self-managed vs Supervised Exercise for Knee OA

ConditionKnee Osteoarthritis

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age45+

SponsorMarius Henriksen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

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
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.

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: Self-managed exerciseExperimental treatment 1 intervention

Group B: Physiotherapist-supervised exerciseActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame