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

NCT06391554 | Recruiting DMC

• 1 other identifier: EDUEX
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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.

  Measured at baseline, 12 weeks and 12 month follow-up

• 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

  Measured at baseline and 12 month follow-up

Secondary Outcomes (10)

• Changes in the Scoring Hip Osteoarthritis with MRI (SHOMRI) semiquantitative scoring system for evaluating imaging features relevant to the severity and progression of osteoarthritis

  Measured at baseline and 12 month follow-up

• Change in the HOOS Pain subscale

  Measured at baseline, 12 weeks and 12 month follow-up

• Change in the HOOS Hip-related Quality of Life subscale

  Measured at baseline, 12 weeks and 12 month follow-up

• 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.

  Measured at baseline and 12 month follow-up

• Change in the HOOS Symptoms subscale

  Measured at baseline, 12 weeks and 12 month follow-up

Other Outcomes (36)

• 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.

  Measured at baseline (treatment received, weight, co-morbidities, and analgesic use is also measured at 12 weeks and 12 month follow-up

• Safety outcomes will include number of adverse events and serious adverse events (SAE)

  Recorded throughout the trial (up to 1 year)

• Participants who drop out from the trial

  Recorded throughout the trial (up to 1 year)

Study Arms (2)

PRT + EDU

EXPERIMENTAL

Other: PRT; Other: EDU

EDU

ACTIVE COMPARATOR

Other: EDU

Interventions

PRT OTHER

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.

PRT + EDU

EDU OTHER

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.

EDU; PRT + EDU

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Comorbidity that markedly influences hip function or degeneration of tissue in or around the hip joint (rheumatic, neurological, mental or other)
• 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

Sponsors & Collaborators

• Aarhus University Hospital: collaborator
• Regionshospitalet Silkeborg: collaborator
• Vejle Hospital: collaborator
• Physiotherapy Associates: collaborator
• Gødstrup Hospital: collaborator
• University of Aarhus: lead

Study Sites (2)

Aarhus University

Aarhus C, 8000, Denmark

NOT YET RECRUITING

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Troels Kjeldsen, MSc

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Thomas Frydendal, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Inger Mechlenburg, Prof.

  Aarhus University Hospital

  STUDY DIRECTOR

• Ulrik Dalgas, Prof.

  University of Aarhus

  STUDY DIRECTOR

Central Study Contacts

Troels Kjeldsen, MSc

CONTACT

4560137627; tkjeldsen@clin.au.dk

Thomas Frydendal, PhD

CONTACT

4525614618; thomas.frydendal@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 30, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available after publication of the trial
• Access Criteria: Data access will be reviewed by the author group. Requesters will be required to sign a data access agreement.

Locations

DK (2)