Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Recruiting · NCT06391554 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Aarhus
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
- Age ≥ 45 years
- Adequacy in written and spoken Danish
Exclusion criteria
- 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
- Resistance exercise (weights or elastic bands) for the lower extremities exceeding 12 sessions over the last 6 months or 6 sessions over the last 3 months
- Suffering from claustrophobia or not tolerating whole body MRI scanner
- Metallic implants from the waist to just above the knee
- Pacemaker or other medical devices that are not MR approved
Where it is running
2 locations listed.
- Aarhus University - Aarhus C, Denmark
- Aarhus University Hospital - Aarhus N, Denmark