Hip DysplasiaMovetheHipNCT04795843
Exercise and Patient Education Compared With Usual Care in Patients With Hip Dysplasia
A study testing Exercise and patient education in people with Hip Dysplasia, run by University of Aarhus at 2 sites in Denmark.
Trial summary
This effectiveness trial will investigate if patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain measured by the Copenhagen Hip and Groin Outcome Score (HAGOS) compared with those randomised to usual care over a six-month follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hip Dysplasia
- What is being tested?
- Exercise and patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesDenmark
- Study dates
- 16 Apr 2021to 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Radiographically verified hip dysplasia by a Wiberg's centre edge (CE) angle of 10-25 degrees and an acetabular Index (AI) angle >10 degrees
- Hip and/or groin pain as primary pain for at least three months
- Candidate for periacetabular osteotomy (PAO) but unwilling to undergo PAO, or on a waiting list for surgery (PAO) for 12 months or longer
- Not candidate for PAO (negative impingement test, BMI >25, hip osteoarthritis, age >45 years or reduced hip range of motion)
Who cannot join
- Self-reported pain score >80 points measured with Copenhagen Hip and Groin outcome score
- Any major planned surgery (i.e. arthroplastic surgery or discectomy surgery)
- BMI >35
- Acetabular retroversion defined by crossover sign and posterior wall sign
- Calvé Legg Perthes or epiphysiolysis
- Previous pelvic/hip surgery in index limb
Show all 11Show fewer
- Previous pelvic/hip surgery within the last 2 years in contralateral limb
- Previous surgery due to herniated disc or spondylodesis
- Previous arthroplastic surgery in the hip, knee or ankle
- Physical (pregnancy/trauma), neurological, medical or rheumatic conditions severely affecting the hip function
- Inadequacy in written and spoken Danish, mental illness or other conditions affecting the ability to follow mandatory procedures for participation
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
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Julie S Jacobsen, PhD, 51866165, jsaj@via.dk
Inger Mechlenburg, PhD, 21679062, inger.mechlenburg@clin.au.dk
- Recruiting
Silkeborg Regional Hospital.
Silkeborg, 8600
Charlotte Sørensen, +4540528386, chasoere@rm.dk
About this study
Official title: MovetheHip-trial: The Effectiveness of Exercise and Patient Education Compared With Usual Care on Self-reported Pain in Patients With Hip Dysplasia
This effectiveness trial will investigate if patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain measured by the Copenhagen Hip and Groin Outcome Score (HAGOS) compared with those randomised to usual care over a six-month follow-up period.
Participating patients will be allocated to either exercise and patient education or usual care. Alongside this, a health-economic study and a process-evaluation study will be conducted.
Read the detailed description
This study is a parallel-group superiority randomised controlled trial. Alongside this, a health-economic study and a process-evaluation study will be conducted. Participating patients will be allocated to either exercise and patient education or usual care at a 1:1 ratio. The primary outcome is change in self-reported pain measured with Copenhagen Hip and Groin Outcome Score (HAGOS) from baseline to 6-month follow-up.
The effectiveness of exercise and patient education compared with usual care will be reported in the primary trial paper, including the primary outcome and the following secondary outcomes: HAGOS symptoms, HAGOS function in daily living (ADL), HAGOS function in sport and recreation (sport/recreation), HAGOS participation in physical activity (participation), HAGOS quality of life (QOL), the impact of hip disease with the Short Version of the International Hip Outcome Tool (iHOT-12), lower limb reach length (anterior, posteromedial, posterolateral), single-leg hip for distance (SLHD) test and hip muscle strength (flexion, extension and abduction).
The primary aim of this effectiveness trial is to investigate if patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain measured by the Copenhagen Hip and Groin Outcome Score (HAGOS) compared with those randomised to usual care over a six-month follow-up period.
The primary hypothesis: Patients randomised to exercise and patient education will have a between-group mean change score on the HAGOS pain that is at least 10 points higher than those randomised to usual care over a 6-month follow-up period.
The secondary aims are to compare mean changes between the two groups on the other HAGOS subscales over a 6-month follow-up period. Similar comparisons will be made on self-reported mean changes in the Short Version of the International Hip Outcome Tool (iHOT-12) and mean changes in performance, balance and hip muscle strength.
A full trial protocol will be published and made publicly available. All primary and secondary outcomes will be analysed with the intention-to-treat principle. Between-group differences from baseline to 3-month and 6-month follow-up of continuous outcomes will be estimated using repeated measurement analysis in a mixed-effects model, including patient as a random effect, with a fixed factor for group and time and the corresponding interaction (Group × Time), adjusted for baseline values. Between-group differences of continuous outcomes from baseline to 6-month follow-up will be analysed with an unpaired t-test, where between-group differences of categorical data from baseline to 6-month follow-up will be analysed with a binominal regression model using risk difference as a measure of association. In this paper, all collected outcomes will be listed, and it will be described that the below listed will be reported in other papers (i.e. health-economic study and process-evaluation study) and secondary papers.
In the health-economic study, the investigators will investigate the cost-utility and cost-effectiveness of exercise and patient education compared with usual care over 12 months. Outcomes for this paper will be measured at baseline, 3-, 6-, 9- and 12-month follow-up. Incremental cost-effectiveness ratios (ICER) will be calculated by dividing the difference in costs by the difference in effects (quality-adjusted life years and HAGOS pain). The uncertainty around the ICER and 95% confidence intervals (CIs) surrounding the cost differences will be estimated with 95% bootstrapped CIs based on non-parametric bootstrapping and will be graphically presented on cost-effectiveness planes and cost-effectiveness acceptability curves.
In the process-evaluation study, the investigators will explore the functioning of the intervention by evaluating the implementation, mechanisms of change and the contribution of contextual factors over 6 months.
Implementation includes the implementation process, fidelity, dose and reach. The implementation process will evaluate the structures and resources through which delivery is achieved. Fidelity aspects will evaluate the extent to deliver each component as planned and registered during the intervention period using self-report questionnaires. The dose will evaluate how much intervention is delivered and registered during the intervention period using routine monitoring forms, and reach will be evaluated as patterns in uptake and adherence by baseline patient characteristics registered before and during the intervention period. Mechanisms of change include interactions between the intervention, the intervention providers and the patients. Interactions will be evaluated through four semi-structured focus group interviews with the intervention providers and the expert team (study coordinator, Kristian Thorborg and Julie S. Jacobsen) and quantitative data on reasons for not receiving surgery. Contextual factors will include events, personal understandings and interactions and their possible influence on the implementation. Contextual factors will be evaluated through one-to-one semi-structured interviews during and after the intervention period with 15-20 patients in the intervention group. Findings from quantitative and quantitative analyses will be merged, interpreted and reported jointly.
The below listed will be reported in secondary papers with a clear reference to the primary trial paper and trial registration, and it will hold "secondary analyses from a randomised controlled trial" in the title.
By using subgroup stratification, we will explore if muscle-tendon pain and pain sensitisation modify between-group changes of the primary and secondary outcomes over 6 months. Furthermore, we plan to conduct an instrumental variable analysis on primary and secondary outcomes in an attempt to investigate the efficacy of the intervention. These analyses will be reported in secondary papers with clear reference to the primary trial paper.
In addition, the investigators plan to evaluate the psychometric properties of HAGOS and iHOT-12 in patients with hip dysplasia, and finally, the investigators plan to describe if hip osteoarthritis progresses over 5 and 10 years using the Tönnis osteoarthritis classification.
- Conditions
- Hip Dysplasia
- Being tested
- Exercise and patient education, Usual Care
- Keywords
- Hip Dislocation, Congenital, Exercise, Patient education, Usual care, Effectiveness, Cost-effectiveness, Process evaluation, Periacetabular osteotomy
- Medical subject headings
- Hip Dislocation, Hip Dislocation, Congenital, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and patient educationOther
Over a period of 6-months, patients will be offered eight one-to-one supervised training sessions. In these sessions, patients will be instructed in a home-based exercise programme and given patient education. The programme includes four exercises covering strength and stability training. The exercises will be performed in sets of three with a minimum of 5 repetitions, and patients will be instructed to perform a minimum of three training sessions each week. Each of the exercises can be progressed through three levels of difficulty, allowing for individualised treatment with regard to exercise quality and perceived exertion according to the Borg CR10 scale. Exercises will be performed on a perceived exertion level from somewhat hard (level 5) to very hard (level 7). Patient education includes pain management, a focus on exercise adherence and progression, and advice on physical activity.
Usual CareOther
Patients will follow usual care, including an individual consultation on self-management of hip symptoms and general advice on exercise and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and patient education | Experimental | 6-months Receives: Other: Exercise and patient education |
| Usual Care | Active comparator | 6-months Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported pain measured with The Copenhagen Hip and Groin Outcome Score (HAGOS) (continuous data)
HAGOS pain sub-item measures degree of hip and/or groin pain through ten individual questions on a score from 0 to 100, higher score indicates lower pain.
Measured: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up (health economic study) and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Secondary outcomes (13)
Change in self-reported symptoms measured with HAGOS (continuous data)
HAGOS symptoms sub-item measures hip and/or groin symptoms and difficulties through seven individual questions on a score from 0 to 100, higher score indicates lower symptoms.
Measured: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in self-reported physical function, daily living (ADL) measured with HAGOS (continuous data)
HAGOS ADL sub-item measures degree of difficulty due to hip and/or groin problems through five individual questions on a score from 0 to 100, higher score indicates higher function.
Measured: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in self-reported physical function in sports and recreational activities (sport/recreation) measured with HAGOS (continuous data)
HAGOS sport/recreation sub-item measures degree of difficulty due to hip and/or groin problems through eight individual questions on a score from 0 to 100, higher score indicates higher function.
Measured: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in self-reported participation in physical activities (participation) measured with HAGOS (continuous data)
HAGOS participation sub-item measures how degree of ability to participate in physical activities is affected by hip and/or groin problems through two individual questions on a score from 0 to 100, higher score indicates higher ability to participate in physical activities.
Measured: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in self-reported quality of life (QOL) measured with HAGOS (continuous data)
HAGOS QOL sub-item measures hip-related quality of life through five individual questions on a score from 0 to 100, higher score indicates higher quality of life.
Measured: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in impact of hip disease using the Short Version of the International Hip Outcome Tool (iHOT- 12) (continuous data)
iHOT-12 measures impact of hip disease in young, active patients through 12 questions on a score from 0-100.
Measured: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up. In addition at 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in anterior lower limb reach distance measured with the Y-balance test (continuous data)
Anterior lower limb reach distance measures functional performance when maintaining balance on one leg, reported in cm normalised to limb length.
Measured: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in posteromedial lower limb reach distance measured with the Y-balance test (continuous data)
Posteromedial lower limb reach distance measures functional performance when maintaining balance on one leg, reported in cm normalised to limb length.
Measured: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in posterolateral lower limb reach distance measured with the Y-balance test (continuous data)
Posterolateral lower limb reach distance measures functional performance when maintaining balance on one leg, reported in cm normalised to limb length.
Measured: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in single-leg jump distance measured with single-leg hop for distance test (continuous data)
Single-leg jump test measures functional performance when jumping on one leg, reported in cm normalised to height.
Measured: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in isometric hip flexion strength using a dynamometer with external belt-fixation (continuous data)
Isometric hip flexion test measures isometric maximum voluntary contraction (MVC) in sitting position. Strength values will be normalised to moment arms and weight and reported in Nm/kg bodyweight.
Measured: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in isometric hip extension strength using a dynamometer with external belt-fixation (continuous data)
Isometric hip extension test measures isometric maximum voluntary contraction (MVC) in prone position. Strength values will be normalised to moment arms and weight and reported in Nm/kg bodyweight.
Measured: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in isometric hip abduction strength using a dynamometer with external belt-fixation (continuous data)
Isometric hip abduction test measures isometric maximum voluntary contraction (MVC) in supine position. Strength values will be normalised to moment arms and weight and reported in Nm/kg bodyweight.
Measured: From baseline to 6-month follow-up. Outcome measured at baseline and 6-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 posted12 Mar 2021
- Study start16 Apr 2021
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip DysplasiaStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Research Unit for General Practice, Aarhus University, VIA University College, Copenhagen University Hospital, Hvidovre, Defactum, Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Julie S Jacobsen, PhD, Principal investigator, VIA University CollegeInger Mechlenburg, DMSc, Study director, Aarhus University HospitalKristian Thorborg, PhD, Study chair, Copenhagen University Hospital, HvidovreRasmus Ø Nielsen, PhD, Study chair, University of AarhusStig S Jakobsen, PhD, Study chair, Aarhus University HospitalLisa G Oestergaard, PhD, Study chair, Defactum, Central Denmark RegionKjeld Søballe, PhD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795843
- Sponsor's protocol ID
- MovetheHip
- Acronym
- MovetheHip
- Status last verified
- May 2026
- First submitted
- 9 Mar 2021
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: What data will be shared: All quantitative individual participant data collected during the trial, after deidentification. With whom will data be shared: Researchers who provide a methodologically sound proposal. For what types of analyses: To achieve aims in the approved proposal. The abovementioned is based on Data Sharing Statements for Clinical Trials: A Requirement of the ICMJE located at: http://www.icmje.org/news-and-editorials/data\_sharing\_june\_2017.pdf.
Publications
Jacobsen JS, Evans R, Morgan K, Thorborg K, Oestergaard LG, Sorensen D. An exercise and patient education intervention to reduce pain and physical limitations in adults with acetabular dysplasia: study protocol for a process evaluation integrated within a randomised controlled trial (the MovetheHip trial). Trials. 2024 Jun 24;25(1):411. doi: 10.1186/s13063-024-08262-y.
PubMed 38915128Jacobsen JS, Thorborg K, Nielsen RO, Jakobsen SS, Foldager C, Sorensen D, Oestergaard LG, van Tulder MW, Mechlenburg I. Comparing exercise and patient education with usual care in the treatment of hip dysplasia: a protocol for a randomised controlled trial with 6-month follow-up (MovetheHip trial). BMJ Open. 2022 Sep 20;12(9):e064242. doi: 10.1136/bmjopen-2022-064242.
PubMed 36127096Jacobsen JS, Thorborg K, Sorensen D, Jakobsen SS, Nielsen RO, Oestergaard LG, Soballe K, Mechlenburg I. Feasibility and acceptability of a six-month exercise and patient education intervention for patients with hip dysplasia: A mixed methods study. Musculoskelet Sci Pract. 2022 Oct;61:102615. doi: 10.1016/j.msksp.2022.102615. Epub 2022 Jun 24.
PubMed 35820302
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MovetheHip-trial: The Effectiveness of Exercise and Patient Education Compared With Usual Care on Self-reported Pain in Patients With Hip Dysplasia
- ClinicalTrials.gov ID
- NCT04795843
- Acronym / sponsor ID
- MovetheHip / MovetheHip
- Conditions
- Hip Dysplasia
- Keywords
- Hip Dislocation, Congenital, Exercise, Patient education, Usual care, Effectiveness, Cost-effectiveness, Process evaluation, Periacetabular osteotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Research Unit for General Practice, Aarhus University, VIA University College, Copenhagen University Hospital, Hvidovre, Defactum, Central Denmark Region
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Mar 2021 (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.
This effectiveness trial will investigate if patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain measured by the Copenhagen Hip and Groin Outcome Score (HAGOS) compared with those randomised to usual care over a six-month follow-up period.
Participating patients will be allocated to either exercise and patient education or usual care. Alongside this, a health-economic study and a process-evaluation study will be conducted.
Detailed description
This study is a parallel-group superiority randomised controlled trial. Alongside this, a health-economic study and a process-evaluation study will be conducted. Participating patients will be allocated to either exercise and patient education or usual care at a 1:1 ratio. The primary outcome is change in self-reported pain measured with Copenhagen Hip and Groin Outcome Score (HAGOS) from baseline to 6-month follow-up.
The effectiveness of exercise and patient education compared with usual care will be reported in the primary trial paper, including the primary outcome and the following secondary outcomes: HAGOS symptoms, HAGOS function in daily living (ADL), HAGOS function in sport and recreation (sport/recreation), HAGOS participation in physical activity (participation), HAGOS quality of life (QOL), the impact of hip disease with the Short Version of the International Hip Outcome Tool (iHOT-12), lower limb reach length (anterior, posteromedial, posterolateral), single-leg hip for distance (SLHD) test and hip muscle strength (flexion, extension and abduction).
The primary aim of this effectiveness trial is to investigate if patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain measured by the Copenhagen Hip and Groin Outcome Score (HAGOS) compared with those randomised to usual care over a six-month follow-up period.
The primary hypothesis: Patients randomised to exercise and patient education will have a between-group mean change score on the HAGOS pain that is at least 10 points higher than those randomised to usual care over a 6-month follow-up period.
The secondary aims are to compare mean changes between the two groups on the other HAGOS subscales over a 6-month follow-up period. Similar comparisons will be made on self-reported mean changes in the Short Version of the International Hip Outcome Tool (iHOT-12) and mean changes in performance, balance and hip muscle strength.
A full trial protocol will be published and made publicly available. All primary and secondary outcomes will be analysed with the intention-to-treat principle. Between-group differences from baseline to 3-month and 6-month follow-up of continuous outcomes will be estimated using repeated measurement analysis in a mixed-effects model, including patient as a random effect, with a fixed factor for group and time and the corresponding interaction (Group × Time), adjusted for baseline values. Between-group differences of continuous outcomes from baseline to 6-month follow-up will be analysed with an unpaired t-test, where between-group differences of categorical data from baseline to 6-month follow-up will be analysed with a binominal regression model using risk difference as a measure of association. In this paper, all collected outcomes will be listed, and it will be described that the below listed will be reported in other papers (i.e. health-economic study and process-evaluation study) and secondary papers.
In the health-economic study, the investigators will investigate the cost-utility and cost-effectiveness of exercise and patient education compared with usual care over 12 months. Outcomes for this paper will be measured at baseline, 3-, 6-, 9- and 12-month follow-up. Incremental cost-effectiveness ratios (ICER) will be calculated by dividing the difference in costs by the difference in effects (quality-adjusted life years and HAGOS pain). The uncertainty around the ICER and 95% confidence intervals (CIs) surrounding the cost differences will be estimated with 95% bootstrapped CIs based on non-parametric bootstrapping and will be graphically presented on cost-effectiveness planes and cost-effectiveness acceptability curves.
In the process-evaluation study, the investigators will explore the functioning of the intervention by evaluating the implementation, mechanisms of change and the contribution of contextual factors over 6 months.
Implementation includes the implementation process, fidelity, dose and reach. The implementation process will evaluate the structures and resources through which delivery is achieved. Fidelity aspects will evaluate the extent to deliver each component as planned and registered during the intervention period using self-report questionnaires. The dose will evaluate how much intervention is delivered and registered during the intervention period using routine monitoring forms, and reach will be evaluated as patterns in uptake and adherence by baseline patient characteristics registered before and during the intervention period. Mechanisms of change include interactions between the intervention, the intervention providers and the patients. Interactions will be evaluated through four semi-structured focus group interviews with the intervention providers and the expert team (study coordinator, Kristian Thorborg and Julie S. Jacobsen) and quantitative data on reasons for not receiving surgery. Contextual factors will include events, personal understandings and interactions and their possible influence on the implementation. Contextual factors will be evaluated through one-to-one semi-structured interviews during and after the intervention period with 15-20 patients in the intervention group. Findings from quantitative and quantitative analyses will be merged, interpreted and reported jointly.
The below listed will be reported in secondary papers with a clear reference to the primary trial paper and trial registration, and it will hold "secondary analyses from a randomised controlled trial" in the title.
By using subgroup stratification, we will explore if muscle-tendon pain and pain sensitisation modify between-group changes of the primary and secondary outcomes over 6 months. Furthermore, we plan to conduct an instrumental variable analysis on primary and secondary outcomes in an attempt to investigate the efficacy of the intervention. These analyses will be reported in secondary papers with clear reference to the primary trial paper.
In addition, the investigators plan to evaluate the psychometric properties of HAGOS and iHOT-12 in patients with hip dysplasia, and finally, the investigators plan to describe if hip osteoarthritis progresses over 5 and 10 years using the Tönnis osteoarthritis classification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and patient education | Experimental | Other: Exercise and patient education6-months |
| Usual Care | Active comparator | Other: Usual Care6-months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Radiographically verified hip dysplasia by a Wiberg's centre edge (CE) angle of 10-25 degrees and an acetabular Index (AI) angle >10 degrees
- Hip and/or groin pain as primary pain for at least three months
- Candidate for periacetabular osteotomy (PAO) but unwilling to undergo PAO, or on a waiting list for surgery (PAO) for 12 months or longer
- Not candidate for PAO (negative impingement test, BMI >25, hip osteoarthritis, age >45 years or reduced hip range of motion)
Key exclusion criteria (11 listed)
- Self-reported pain score >80 points measured with Copenhagen Hip and Groin outcome score
- Any major planned surgery (i.e. arthroplastic surgery or discectomy surgery)
- BMI >35
- Acetabular retroversion defined by crossover sign and posterior wall sign
- Calvé Legg Perthes or epiphysiolysis
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 |
|---|---|---|
| Exercise and patient educationOver a period of 6-months, patients will be offered eight one-to-one supervised training sessions. In these sessions, patients will be instructed in a home-based exercise programme and given patient education. The programme includes four exercises covering strength and stability training. The exercises will be performed in sets of three with a minimum of 5 repetitions, and patients will be instructed to perform a minimum of three training sessions each week. Each of the exercises can be progressed through three levels of difficulty, allowing for individualised treatment with regard to exercise quality and perceived exertion according to the Borg CR10 scale. Exercises will be performed on a perceived exertion level from somewhat hard (level 5) to very hard (level 7). Patient education includes pain management, a focus on exercise adherence and progression, and advice on physical activity. | Other | Exercise and patient education |
| Usual CarePatients will follow usual care, including an individual consultation on self-management of hip symptoms and general advice on exercise and physical activity. | Other | Usual Care |
Primary outcome
Change in self-reported pain measured with The Copenhagen Hip and Groin Outcome Score (HAGOS) (continuous data)
Time frame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up (health economic study) and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
HAGOS pain sub-item measures degree of hip and/or groin pain through ten individual questions on a score from 0 to 100, higher score indicates lower pain.
13 secondary outcomes
Change in self-reported symptoms measured with HAGOS (continuous data)
Time frame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in self-reported physical function, daily living (ADL) measured with HAGOS (continuous data)
Time frame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in self-reported physical function in sports and recreational activities (sport/recreation) measured with HAGOS (continuous data)
Time frame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in self-reported participation in physical activities (participation) measured with HAGOS (continuous data)
Time frame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in self-reported quality of life (QOL) measured with HAGOS (continuous data)
Time frame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in impact of hip disease using the Short Version of the International Hip Outcome Tool (iHOT- 12) (continuous data)
Time frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up. In addition at 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in anterior lower limb reach distance measured with the Y-balance test (continuous data)
Time frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in posteromedial lower limb reach distance measured with the Y-balance test (continuous data)
Time frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in posterolateral lower limb reach distance measured with the Y-balance test (continuous data)
Time frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in single-leg jump distance measured with single-leg hop for distance test (continuous data)
Time frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in isometric hip flexion strength using a dynamometer with external belt-fixation (continuous data)
Time frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in isometric hip extension strength using a dynamometer with external belt-fixation (continuous data)
Time frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in isometric hip abduction strength using a dynamometer with external belt-fixation (continuous data)
Time frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-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 15 May 2026.
- Background: PubMed 38915128Jacobsen JS, Evans R, Morgan K, Thorborg K, Oestergaard LG, Sorensen D. An exercise and patient education intervention to reduce pain and physical limitations in adults with acetabular dysplasia: study protocol for a process evaluation integrated within a randomised controlled trial (the MovetheHip trial). Trials. 2024 Jun 24;25(1):411. doi: 10.1186/s13063-024-08262-y.
- Background: PubMed 36127096Jacobsen JS, Thorborg K, Nielsen RO, Jakobsen SS, Foldager C, Sorensen D, Oestergaard LG, van Tulder MW, Mechlenburg I. Comparing exercise and patient education with usual care in the treatment of hip dysplasia: a protocol for a randomised controlled trial with 6-month follow-up (MovetheHip trial). BMJ Open. 2022 Sep 20;12(9):e064242. doi: 10.1136/bmjopen-2022-064242.
- Background: PubMed 35820302Jacobsen JS, Thorborg K, Sorensen D, Jakobsen SS, Nielsen RO, Oestergaard LG, Soballe K, Mechlenburg I. Feasibility and acceptability of a six-month exercise and patient education intervention for patients with hip dysplasia: A mixed methods study. Musculoskelet Sci Pract. 2022 Oct;61:102615. doi: 10.1016/j.msksp.2022.102615. Epub 2022 Jun 24.
- Individual participant dataSharing planned: Yes. What data will be shared: All quantitative individual participant data collected during the trial, after deidentification. With whom will data be shared: Researchers who provide a methodologically sound proposal. For what types of analyses: To achieve aims in the approved proposal. The abovementioned is based on Data Sharing Statements for Clinical Trials: A Requirement of the ICMJE located at: http://www.icmje.org/news-and-editorials/data_sharing_june_2017.pdf.
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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.
Julie S Jacobsen, PhD principal investigator
VIA University College
Inger Mechlenburg, DMSc study director
Aarhus University Hospital
Kristian Thorborg, PhD study chair
Copenhagen University Hospital, Hvidovre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and patient education in people with Hip Dysplasia, 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 4 inclusion and 11 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 15 May 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 Julie S Jacobsen, PhD (4551866165, jsaj@via.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported pain measured with The Copenhagen Hip and Groin Outcome Score (HAGOS) (continuous data) (time frame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up (health economic study) and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04795843, which also lists 3 linked publications.
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 15 May 2026.