NCT07210931: SELFIT

Self-managed vs Supervised Exercise for Knee OA

Not yet recruiting NA Last updated 7 October 2025

What this trial tests

NA trial testing Self-managed exercise in a fitness center in Knee Osteoarthritis in 300 participants. Not yet recruiting.

Timeline

1 November 2025

Primary endpoint
1 April 2027

1 July 2027

Quick facts

Lead sponsor	Marius Henriksen
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	1 November 2025
Primary completion	1 April 2027
Estimated completion	1 July 2027

Drugs / interventions tested

• Self-managed exercise in a fitness center
• Supervised Exercise

Conditions studied

• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

Marius Henriksen — full company profile →

Who can join

45 and older, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.