NCT Number: NCT07210931
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.
Trial opening soon.
Get Notified45 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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.
Time frame: 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 .
Time frame: 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:
Time frame: After 1, 2, 3, 4, 5, 6 months
The participants' use of over-the-counter paracetamol and ibuprofen will be collected via questionnaire.
Analgesics usage is recorded as a response to the questions "How often do you take pain relieving medicine* for your knee OA pain" with response options 1) Daily; 2) 2-3 times per week: 3) Rarer; or 4) Never. Responses 1 and 2 defines an analgesics user, whereas responses 3 and 4 defines a non-user.
Time frame: After 1, 2, 3, 4, 5, 6 months
Sleep quality will be obtained with the global Single-item sleep quality scale (SQS).
Time frame: After 1, 2, 3, 4, 5, 6 months
Self-reported physical activity will be obtained with the University of California Loas Angeles activity scale (UCLA). UCLA is a single-item 10-level-scale, ranging from level 10, representing a highly physically active patient, to level 1, a patient who is dependent on others and unable to leave home.
Time frame: After 1, 2, 3, 4, 5, 6 months
The cost for patients questionnaire (CoPaQ) is a comprehensive tool to measure direct and indirect out-of-pocket costs of a health condition for patients and their families to various outpatient contexts.
Time frame: After 1, 2, 3, 4, 5, 6 months
Self-reported mental well-being will be obtained with the WHO5-Well-Being Index consisting of five questions.
Time frame: After 1, 2, 3, 4, 5, 6 months
Is recorded as kilograms and obtained self-reported via questionnaire
Time frame: After 1, 2, 3, 4, 5, 6 months
The Knee injury and Osteoarthritis Outcome Score (KOOS) consists of 42 items covering five subscales (domains): 1) Pain; 2) Function; 3) Knee related quality of life; 4) Symptoms; 5) Sports and Recreation.
The KOOS adopts a five-point Likert scale scoring system (ranging from 0 (least severe) to 4 (most severe)). A normalized score is calculated for each subscale (domain) with 100 indicating best score and 0 indicating the worst score.
Time frame: After 1, 2, 4, 5, 6 months
EQ-5D-5L is a standardized patient-reported instrument for use as a measure of health outcome and quality of life.
Time frame: After 1, 2, 4, 5, 6 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".
Time frame: After 6 months
Number of treatment responders according to OMERACT-OARSI response criteria, following two conditions is observed at the post-baseline assessment:
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
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)
Contact information is provided by the study sponsor or research team.
Camilla P Paulsen, Phd student
CONTACT
Marius Henriksen, Professor
CONTACT
Marius Henriksen
Other
A Cluster Randomized Trial in Patients With Knee Osteoarthritis Comparing Self-Managed Exercise in Fitness Centers With Physiotherapist-Supervised Exercise in Primary Care
Acronym: SELFIT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07649291
Arthritis, Behavior
Baltimore, Maryland, United States
View Trial DetailsNCT05173064
Arthritis, Behavior
Hong Kong
View Trial DetailsNCT07391449
Arthritis, Behavior
Kowloon, Hong Kong
View Trial DetailsNCT07333690
Arthritis, Behavior
View Trial Details