Self-managed vs Supervised Exercise for Knee OA

NCT07210931 | Not Yet Recruiting

• 1 other identifier: APPI-MSK-OA-SELFIT
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Health outcome and quality of life survey (EQ-5D-5L)

  Change from baseline after 3 months

• Patient Global Assessment of disease impact (PGA)

  Change from baseline after 3 months

• KOOS Function subscale

  Change from baseline after 3 months

• KOOS quality of Life (QOL) subscale

  Change from baseline after 3 months

• OMERACT-OARSI responder criteria

  3 months

Other Outcomes (10)

• Analgesics usage

  After 1, 2, 3, 4, 5, 6 months

• Sleep Quality Single-item sleep quality scale (SQS)

  After 1, 2, 3, 4, 5, 6 months

• Self-reported physical activity (UCLA activity scale)

  After 1, 2, 3, 4, 5, 6 months

Study Arms (2)

Self-managed exercise

EXPERIMENTAL

Behavioral: Self-managed exercise in a fitness center

Physiotherapist-supervised exercise

ACTIVE COMPARATOR

Behavioral: Supervised Exercise

Interventions

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

Self-managed exercise

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.

Physiotherapist-supervised exercise

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Marius Henriksen: lead
• University of Copenhagen: collaborator
• Research Unit for General Practice in Aalborg: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Central Study Contacts

Marius Henriksen, Professor

CONTACT

0045 38164155; Marius.Henriksen@regionh.dk

Camilla P Paulsen, Phd student

CONTACT

0045 24854096; Camilla.paludan.paulsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 7, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP