Self-managed vs Supervised Exercise for Knee OA

NCT ID: NCT07210931

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-07-01

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Self-managed exercise

Group Type: EXPERIMENTAL

Self-managed exercise in a fitness center

Intervention Type: 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

Physiotherapist-supervised exercise

Group Type: ACTIVE_COMPARATOR

Supervised Exercise

Intervention Type: 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.

Interventions

Self-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

Intervention Type: BEHAVIORAL

Supervised 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Section of General Practice, University of Copenhagen

UNKNOWN

Sponsor Role: collaborator

Research Unit for General Practice in Aalborg

OTHER

Sponsor Role: collaborator

Marius Henriksen

OTHER

Sponsor Role: lead

Responsible Party

Marius Henriksen

PROFESSOR

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Marius Henriksen, Professor

Role: CONTACT

Marius.Henriksen@regionh.dk

0045 38164155

Camilla P Paulsen, Phd student

Role: CONTACT

Camilla.paludan.paulsen@regionh.dk

0045 24854096

Other Identifiers

APPI-MSK-OA-SELFIT

Identifier Type: -

Identifier Source: org_study_id