RecruitingNot ApplicableNCT06391554

Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis

Sponsor

University of Aarhus

Enrollment

150 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

hip osteoarthritis

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

Min Age: 45 Years

Inclusion Criteria6

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 Criteria8

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

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Interventions

OTHERPRT

An 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.

OTHEREDU

Three 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.