The EDUEX trial will determine whether the addition of progressive resistance training (PRT) to a patient education program (EDU) will improve clinical outcomes in patients with hip OA.
In a subsample, the effect of PRT on the articular cartilage and other structures of the hip joint is investigated. In this subsample, a comprehensive assessment of possible mechanisms underlying the effects of exercise on pain and function is undertaken.
The EduEx trial will be a multicentre, stratified (by site), block randomized (allocation 1:1), controlled, parallel-group superiority trial. 150 people with hip OA will be recruited from hospitals, physiotherapy clinics, social media and newspapers. Participants will be randomized to PRT and EDU or EDU alone. All 150 participants will be included in the clinical evaluation study (CLIN). The last 40 participants randomized to PRT+EDU and to EDU, respectively, will also be included in the mechanistic (MECH) evaluation study (n=80), by being asked to participate in additional outcome assessments. The primary endpoint will be the 12 months follow-up for both the CLIN and MECH study, while a secondary endpoint will be the 3-month follow-up.
Clinically diagnosed with hip OA according to the criteria by the National Institute for Health and Care Excellence (NICE)
Radiographic verification of hip OA diagnosis with Kellgren Lawrence score of 2 or 3 in one or both hips
Not scheduled for a total hip replacement within the following 12 months
An event of hip pain every day of at least 3 out of 10 on a numerical rating scale during the last 14 days
Comorbidity that markedly influences hip function or degeneration of tissue in or around the hip joint (rheumatic, neurological, mental or other)
Surgery in the lower extremities within the six months prior to inclusion
BMI > 40
Pregnancy
Parallel
PRT
Other interventionAn initial 12-week exercise intervention, consisting of 1-hour group sessions of progressive resistance training supervised by a physiotherapist 2 times per week. The sessions consist of a 10-minute submaximal warm up on an exercise bike followed by 50 minutes of PRT with exercises targeting the muscles of the hip and knee joints; leg press, hip extension, hip abduction, hip flexion and knee extension. The progression will be in line with guidelines provided by the American College of Sports Medicine. The intensity will follow repetition maximum (RM) targets, from 12 RM for the first week towards 8 RM for the last weeks. After the 12 weeks, participants will receive 8 booster sessions and are given a membership to a fitness center where they will be encouraged to continue the exercise program on their own.
EDU
Other interventionThree EDU sessions provided by a trained physiotherapist involving important disease-specific information. The sessions will address knowledge of OA, treatment options with a specific focus on physical activity recommendations, advice on self-management and more. All three sessions will emphasize on engaging the participants actively and sharing experiences with each other.
Changes from baseline to 12 month follow-up (primary endpoint) in the Hip Disability and Osteoarthritis Outcome Score (HOOS) ADL function subscale
Primary outcome for the CLIN study and secondary outcome for the MECH study. The HOOS ADL function subscale is a 17-item patient-reported outcome measure designed to assess ADL function in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better ADL function status.
Changes from baseline to 12-month follow-up (primary endpoint) in the hip articular cartilage of the index hip measured by MRI T2 relaxation time mapping.
Primary outcome for the MECH study
Changes in the Scoring Hip Osteoarthritis with MRI (SHOMRI) semiquantitative scoring system for evaluating imaging features relevant to the severity and progression of osteoarthritis
Key secondary outcome for the MECH study. The scoring system cardinal features related to osteoarthritis of the hip joint on a scale of 0-5 (where 5 is most severe). These features are: articular cartilage loss, bone marrow edema pattern, subchondral cysts, labral abnormality, paralabral cysts, intra-articular bodies, effusion/synovitis and ligamentum teres abnormality.
Change in the HOOS Pain subscale
Key secondary outcome for the CLIN study and for the MECH study. The HOOS pain subscale is a 10-item patient-reported outcome measure designed to assess hip pain in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better pain status.
Change in the HOOS Hip-related Quality of Life subscale
Key secondary outcome for the CLIN study and secondary outcome for MECH study. The HOOS quality-of-life subscale is a four-item patient-reported outcome measure designed to assess hip-related quality-of-life in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better quality-of-life status.
Changes from baseline to 12-month follow-up (primary endpoint) in the articular cartilage of the index hip measured by MRI T1rho relaxation time mapping.
Secondary outcome for the MECH study. This outcome was changed from co-primary to secondary outcome on 09/17/2025 where 68 participants had been included in the trial and no MECH participant was included or had attended baseline assessment. As such, no MRI scans had been conducted for trial participants at this time. This change was made due to persistent technical issues with the T1r MRI scanning sequence resulting in a high risk of missing data for this outcome.
Demographic data consisting of sex, age, weight, height, BMI, analgesics, cohabiting status, marital status, employment status, alcohol intake, smoking habits, duration and severity of symptoms, current and previous treatment, co-morbidities.
Descriptive data for CLIN study and MECH study
Safety outcomes will include number of adverse events and serious adverse events (SAE)
Descriptive data for CLIN study and MECH study. SAE are defined according to the International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines.
Participants who drop out from the trial
Descriptive data for CLIN study and MECH study
Adherence to PRT exercise program
Descriptive data for CLIN study and MECH study. Recorded as attendance to each session (yes/no) and presented as number of and proportion of sessions attended
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University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Regionshospitalet Silkeborg
Collaborator
Vejle Hospital
Collaborator
Physiotherapy Associates
Collaborator
Gødstrup Hospital
Collaborator
