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

Conditions

• Hip Osteoarthritis

Interventions

OTHER

PRT

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.

OTHER

EDU

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.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Regionshospitalet Silkeborg

  collaborator OTHER

• Vejle Hospital

  collaborator OTHER

• Physiotherapy Associates

  collaborator OTHER

• Gødstrup Hospital

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Troels Kjeldsen, MSc · Aarhus University Hospital

• Thomas Frydendal, PhD · Aarhus University Hospital

• Inger Mechlenburg, Prof. · Aarhus University Hospital

• Ulrik Dalgas, Prof. · University of Aarhus

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2027-05-01

Completion

2027-05-01

Countries

• Denmark

Study Locations