NCT06391554 Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
| NCT ID | NCT06391554 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Hip Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-05-01 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Troels Kjeldsen, MSc
PRINCIPAL INVESTIGATOR
Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT06391554 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Hip Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06391554 currently recruiting?
Yes, NCT06391554 is actively recruiting participants. Contact the research team at tkjeldsen@clin.au.dk for enrollment information.
Where is the NCT06391554 trial being conducted?
This trial is being conducted at Aarhus C, Denmark, Aarhus N, Denmark.
Who is sponsoring the NCT06391554 clinical trial?
NCT06391554 is sponsored by University of Aarhus. The principal investigator is Troels Kjeldsen, MSc at Aarhus University Hospital. The trial plans to enroll 150 participants.