Hip OsteoarthritisEDUEXNCT06391554
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
A study testing PRT and EDU in people with Hip Osteoarthritis, run by University of Aarhus at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- PRT and EDU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 May 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Not yet recruiting
Aarhus University
Aarhus C, 8000
Ulrik Dalgas, Prof., +45 40123039, dalgas@ph.au.dk
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Inger Mechlenburg, Prof., +45 78467471, inger.mechlenburg@clin.au.dk
About this study
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.
Read the detailed description
DESIGN
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 the Orthopedic Departments at hospitals and from physiotherapy clinics, social media and newspapers. Participants will be randomized to PRT+EDU or EDU.
All 150 participants will be included in the clinical evaluation study (CLIN) while only the last 40 participants randomized to PRT+EDU and EDU, respectively, will also be included in the mechanistic evaluation study (MECH, n=80), by being asked to participate in additional outcome assessments including magnetic resonance imaging of the hip.
The primary endpoint will be the 12 months follow-up for both the CLIN and MECH study, while the secondary endpoint will be the 3-month follow-up.
RANDOMIZATION
After baseline assessment, participants will be randomized in a 1:1 ratio to PRT+EDU or EDU. A computer-generated list of random numbers will be generated in the Research Electronic Data Capture (REDCap) system. The randomization will be stratified by site and block randomized, to ensure equal distribution of allocations among trial sites. Two lists of random numbers will be generated, one for the first 70 participants and one for the last 80 participants recruited, to enable an even distribution of treatment allocation of the 80 participants in the MECH subsample. Treatment allocation will be concealed as one of the principal investigators will use the randomization tool only after the baseline assessment has been performed.
INTERVENTIONS
The PRT and EDU interventions will be conducted either at the collaborating hospital departments or physiotherapy clinics across Denmark.
PRT: Participants allocated to receive PRT will attend 3 months of supervised PRT followed by 9 months of unsupervised PRT with the addition of 8 exercise booster sessions. The PRT program consists of two weekly training sessions (60 min per session) with ≥48 hours of rest between sessions. All supervised PRT sessions will be group-based (up to 5 participants) supervised by one physiotherapist.
EDU: Both treatment arms will attend 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.
STATISTICAL ANALYSIS PLAN
The analyses will be based on the between-group difference in change in the primary and secondary outcomes from baseline to the 12 months follow-up, according to the intention-to-treat (ITT) principle. Additionally, per protocol analyses will be performed including only participants with high adherence to the EDU sessions (at least 2 sessions attended) and high adherence to the exercise sessions (≥80% of the planned sessions completed) and high exercise fidelity (≥80% of prescribed repetitions performed). Between-group comparisons of change from baseline to follow-up in the primary and secondary continuous outcomes will be analysed using a repeated measures mixed model with participants and sites as random effects and with visits and treatment arm as fixed effects.
DATA MANAGEMENT
All data and outcomes collected from participants will be entered into the REDCap database. For the patient reported outcomes, participants will fill out questionnaires directly into REDCap. If a participant is unable to do so, they will fill out paper versions of the questionnaires and the tester will enter it into REDCap and shred the paper versions. The data will be maintained in storage for five years after trial termination.
PATIENT AND PUBLIC INVOLVEMENT
In the EduEx trial we have established an advisory board of four patients with hip osteoarthritis and a physiotherapists. Patients and physiotherapists have been invited to participate in the board throughout the research project. The board have and will continue to influence clinical outcomes, practicalities, and content of the interventions. The board will have one meeting every three months during the planning, conducting and dissemination processes of the trial and will give advice (consultation level of involvement) throughout.
ETHICAL CONSIDERATIONS
The study intervention is non-invasive and is expected to result in a generally optimized health status of the included participants. Approval from the Central Denmark Region Committee on Health Research has been obtained for the EduEx trial. Written informed consent will be obtained from all participants prior to inclusion and the project will be performed in accordance with the Helsinki Declaration. Authorship eligibility will be based on the recommendations from The International Committee of Medical Journal Editors. Any important protocol amendments for The EduEx trial will be registered at ClinicalTrial.gov and reported to the Central Denmark Region Committee on Health Research.
RESEARCH RESULTS
The results from this trial will be published in peer-reviewed scientific journals and presented at congresses, regardless of whether the results are inconclusive, negative or positive.
There are 3 preplanned studies to be conducted on the results from this trial that will be reported in 3 separate research papers:
- The primary clinical evaluation study (CLIN) comparing effects of PRT+EDU and EDU alone on the primary outcome of HOOS ADL is study number one.
- The primary mechanistic evaluation study (MECH) comparing PRT+EDU and EDU alone on changes in hip joint tissue is study number two.
- A secondary MECH evaluation study (MECH2) is study number three, in which the mechanisms of exercise are investigated by looking at associations of changes in other outcomes with the changes seen for hip pain and physical function.
- Conditions
- Hip Osteoarthritis
- Being tested
- PRT, EDU
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRTOther
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.
EDUOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PRT + EDU | Experimental | Not described Receives: Other: PRT; Other: EDU |
| EDU | Active comparator | Not described Receives: Other: EDU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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
Key secondary outcome for the MECH study. The scoring system cardinal features related to osteoarthritis of the hip joint on a scale of 0-5 (where 5 is most severe). These features are: articular cartilage loss, bone marrow edema pattern, subchondral cysts, labral abnormality, paralabral cysts, intra-articular bodies, effusion/synovitis and ligamentum teres abnormality.
Measured: Measured at baseline and 12 month follow-up
Change in the HOOS Pain subscale
Key secondary outcome for the CLIN study and for the MECH study. The HOOS pain subscale is a 10-item patient-reported outcome measure designed to assess hip pain in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better pain status.
Measured: Measured at baseline, 12 weeks and 12 month follow-up
Change in the HOOS Hip-related Quality of Life subscale
Key secondary outcome for the CLIN study and secondary outcome for MECH study. The HOOS quality-of-life subscale is a four-item patient-reported outcome measure designed to assess hip-related quality-of-life in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better quality-of-life status.
Measured: 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.
Secondary outcome for the MECH study.
This outcome was changed from co-primary to secondary outcome on 09/17/2025 where 68 participants had been included in the trial and no MECH participant was included or had attended baseline assessment. As such, no MRI scans had been conducted for trial participants at this time. This change was made due to persistent technical issues with the T1r MRI scanning sequence resulting in a high risk of missing data for this outcome.
Measured: Measured at baseline and 12 month follow-up
Change in the HOOS Symptoms subscale
Secondary outcome for the CLIN study and MECH study. The HOOS symptoms subscale is a five-item patient-reported outcome measure designed to assess other hip symptoms in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better symptoms status.
Measured: Measured at baseline, 12 weeks and 12 month follow-up
Change in the HOOS Sport/recreation subscale
Secondary outcome for the CLIN study and MECH study. The HOOS sports and recreation subscale is a four-item patient-reported outcome measure designed to assess sports and recreation function in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better sports and recreation status.
Measured: Measured at baseline, 12 weeks and 12 month follow-up
Change in the 30 second chair stand test
Secondary outcome for the CLIN study and exploratory outcome for MECH study. The 30s-CST is a physical function test designed to assess sit-to-stand function (number of repetitions).
Measured: Measured at baseline, 12 weeks, and 12 month follow-up
Change in the 9-step stair climb test
Secondary outcome for the CLIN study and exploratory outcome for MECH study. Measures time (in seconds) taken to negotiate 9 steps on a standard step-height stair-way (up and down).
Measured: Measured at baseline, 12 weeks, and 12 month follow-up
Change in the 40 meter fast-paced walk test
Secondary outcome for the CLIN study and exploratory outcome for MECH study. The 40m-FPWT is a physical function test designed to assess short distance maximum walking speed.
Measured: Measured at baseline, 12 weeks, and 12 month follow-up
Number of treatment responders according to OMERACT-OARSI response criteria
Secondary outcome for the CLIN study. The criteria are:
- In either pain (HOOS pain subscale) or function (HOOS ADL function subscale), a high improvement in the subscale, where high improvement in a subscale is achieved if there is both a > 50% improvement from Baseline and an absolute change from Baseline of > 20 points (0-100 scale), OR
Improvement in at least two of the following three:
Improvement in pain (HOOS pain subscale) defined as > 20% improvement from Baseline and an absolute change from Baseline of > 10 points (0-100 scale) Improvement in function (HOOS ADL function subscale) defined as > 20% improvement from Baseline and an absolute change from Baseline of > 10 points (0-100 scale) Improvement in patient's global assessment defined as > 20% improvement from Baseline and an absolute change from Baseline of > 10 mm (0-100 scale)
Measured: Measured at 12 weeks and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 May 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Silkeborg, Vejle Hospital, Physiotherapy Associates, Gødstrup Hospital
- Responsible party
- Sponsor
- Investigators
- Troels Kjeldsen, MSc, Principal investigator, Aarhus University HospitalThomas Frydendal, PhD, Principal investigator, Aarhus University HospitalInger Mechlenburg, Prof., Study director, Aarhus University HospitalUlrik Dalgas, Prof., Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391554
- Sponsor's protocol ID
- EDUEX
- Acronym
- EDUEX
- Status last verified
- Nov 2026
- First submitted
- 22 Apr 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised patient-level data will be made available if required by the scientific journal, in which the results of the trial are published. Additionally, researchers presenting a justified cause for receiving the data can obtain it after a data access agreement has been signed.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT06391554
- Acronym / sponsor ID
- EDUEX / EDUEX
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Silkeborg, Vejle Hospital, Physiotherapy Associates, Gødstrup Hospital
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
DESIGN
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 the Orthopedic Departments at hospitals and from physiotherapy clinics, social media and newspapers. Participants will be randomized to PRT+EDU or EDU.
All 150 participants will be included in the clinical evaluation study (CLIN) while only the last 40 participants randomized to PRT+EDU and EDU, respectively, will also be included in the mechanistic evaluation study (MECH, n=80), by being asked to participate in additional outcome assessments including magnetic resonance imaging of the hip.
The primary endpoint will be the 12 months follow-up for both the CLIN and MECH study, while the secondary endpoint will be the 3-month follow-up.
RANDOMIZATION
After baseline assessment, participants will be randomized in a 1:1 ratio to PRT+EDU or EDU. A computer-generated list of random numbers will be generated in the Research Electronic Data Capture (REDCap) system. The randomization will be stratified by site and block randomized, to ensure equal distribution of allocations among trial sites. Two lists of random numbers will be generated, one for the first 70 participants and one for the last 80 participants recruited, to enable an even distribution of treatment allocation of the 80 participants in the MECH subsample. Treatment allocation will be concealed as one of the principal investigators will use the randomization tool only after the baseline assessment has been performed.
INTERVENTIONS
The PRT and EDU interventions will be conducted either at the collaborating hospital departments or physiotherapy clinics across Denmark.
PRT: Participants allocated to receive PRT will attend 3 months of supervised PRT followed by 9 months of unsupervised PRT with the addition of 8 exercise booster sessions. The PRT program consists of two weekly training sessions (60 min per session) with ≥48 hours of rest between sessions. All supervised PRT sessions will be group-based (up to 5 participants) supervised by one physiotherapist.
EDU: Both treatment arms will attend 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.
STATISTICAL ANALYSIS PLAN
The analyses will be based on the between-group difference in change in the primary and secondary outcomes from baseline to the 12 months follow-up, according to the intention-to-treat (ITT) principle. Additionally, per protocol analyses will be performed including only participants with high adherence to the EDU sessions (at least 2 sessions attended) and high adherence to the exercise sessions (≥80% of the planned sessions completed) and high exercise fidelity (≥80% of prescribed repetitions performed). Between-group comparisons of change from baseline to follow-up in the primary and secondary continuous outcomes will be analysed using a repeated measures mixed model with participants and sites as random effects and with visits and treatment arm as fixed effects.
DATA MANAGEMENT
All data and outcomes collected from participants will be entered into the REDCap database. For the patient reported outcomes, participants will fill out questionnaires directly into REDCap. If a participant is unable to do so, they will fill out paper versions of the questionnaires and the tester will enter it into REDCap and shred the paper versions. The data will be maintained in storage for five years after trial termination.
PATIENT AND PUBLIC INVOLVEMENT
In the EduEx trial we have established an advisory board of four patients with hip osteoarthritis and a physiotherapists. Patients and physiotherapists have been invited to participate in the board throughout the research project. The board have and will continue to influence clinical outcomes, practicalities, and content of the interventions. The board will have one meeting every three months during the planning, conducting and dissemination processes of the trial and will give advice (consultation level of involvement) throughout.
ETHICAL CONSIDERATIONS
The study intervention is non-invasive and is expected to result in a generally optimized health status of the included participants. Approval from the Central Denmark Region Committee on Health Research has been obtained for the EduEx trial. Written informed consent will be obtained from all participants prior to inclusion and the project will be performed in accordance with the Helsinki Declaration. Authorship eligibility will be based on the recommendations from The International Committee of Medical Journal Editors. Any important protocol amendments for The EduEx trial will be registered at ClinicalTrial.gov and reported to the Central Denmark Region Committee on Health Research.
RESEARCH RESULTS
The results from this trial will be published in peer-reviewed scientific journals and presented at congresses, regardless of whether the results are inconclusive, negative or positive.
There are 3 preplanned studies to be conducted on the results from this trial that will be reported in 3 separate research papers:
- The primary clinical evaluation study (CLIN) comparing effects of PRT+EDU and EDU alone on the primary outcome of HOOS ADL is study number one.
- The primary mechanistic evaluation study (MECH) comparing PRT+EDU and EDU alone on changes in hip joint tissue is study number two.
- A secondary MECH evaluation study (MECH2) is study number three, in which the mechanisms of exercise are investigated by looking at associations of changes in other outcomes with the changes seen for hip pain and physical function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRT + EDU | Experimental | Other: PRT, Other: EDU |
| EDU | Active comparator | Other: EDU |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRTAn 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 | PRT + EDU |
| EDUThree 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. | Other | EDU, PRT + EDU |
Primary outcome
Changes from baseline to 12 month follow-up (primary endpoint) in the Hip Disability and Osteoarthritis Outcome Score (HOOS) ADL function subscale
Time frame: Measured at baseline, 12 weeks and 12 month follow-up
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.
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.
Time frame: Measured at baseline and 12 month follow-up
Primary outcome for the MECH study
10 secondary outcomes
Changes in the Scoring Hip Osteoarthritis with MRI (SHOMRI) semiquantitative scoring system for evaluating imaging features relevant to the severity and progression of osteoarthritis
Time frame: Measured at baseline and 12 month follow-up
Change in the HOOS Pain subscale
Time frame: Measured at baseline, 12 weeks and 12 month follow-up
Change in the HOOS Hip-related Quality of Life subscale
Time frame: 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.
Time frame: Measured at baseline and 12 month follow-up
Change in the HOOS Symptoms subscale
Time frame: Measured at baseline, 12 weeks and 12 month follow-up
Change in the HOOS Sport/recreation subscale
Time frame: Measured at baseline, 12 weeks and 12 month follow-up
Change in the 30 second chair stand test
Time frame: Measured at baseline, 12 weeks, and 12 month follow-up
Change in the 9-step stair climb test
Time frame: Measured at baseline, 12 weeks, and 12 month follow-up
Change in the 40 meter fast-paced walk test
Time frame: Measured at baseline, 12 weeks, and 12 month follow-up
Number of treatment responders according to OMERACT-OARSI response criteria
Time frame: Measured at 12 weeks and 12 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. Anonymised patient-level data will be made available if required by the scientific journal, in which the results of the trial are published. Additionally, researchers presenting a justified cause for receiving the data can obtain it after a data access agreement has been signed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Troels Kjeldsen, MSc principal investigator
Aarhus University Hospital
Thomas Frydendal, PhD principal investigator
Aarhus University Hospital
Inger Mechlenburg, Prof. study director
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRT and EDU in people with Hip Osteoarthritis, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Troels Kjeldsen, MSc (4560137627, tkjeldsen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline to 12 month follow-up (primary endpoint) in the Hip Disability and Osteoarthritis Outcome Score (HOOS) ADL function subscale (time frame: Measured at baseline, 12 weeks and 12 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.