Exercise and Patient Education Compared With Usual Care in Patients With Hip Dysplasia

NCT04795843 | Recruiting

• 1 other identifier: MovetheHip
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Hip Dysplasia

Keywords

Hip Dislocation, Congenital; Exercise; Patient education; Usual care; Effectiveness; Cost-effectiveness; Process evaluation; Periacetabular osteotomy

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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)

  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)

  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)

  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)

Other Outcomes (23)

• Self-reported acceptable symptom state using the Patient Acceptable Symptom State (PASS) (dichotome data)

  Measured at 6- and 12-month follow-up

• Change in self-reported hip and/or groin pain intensity measured with a 100 mm Visual Analogue Scale (VAS) for pain in rest (continuous data)

  From baseline to 6-month follow-up. Outcome measured at baseline, 6- and 12-month follow-up

• Change in self-reported hip and/or groin pain intensity measured with a 100 mm Visual Analogue Scale (VAS) for pain during physical activity (continuous data)

  From baseline to 6-month follow-up. Outcome measured at baseline, 6- and 12-month follow-up

Study Arms (2)

Exercise and patient education

EXPERIMENTAL

6-months

Other: Exercise and patient education

Usual Care

ACTIVE COMPARATOR

6-months

Other: Usual Care

Interventions

Exercise and patient education OTHER

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.

Exercise and patient education

Usual Care OTHER

Patients will follow usual care, including an individual consultation on self-management of hip symptoms and general advice on exercise and physical activity.

Usual Care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Aarhus: lead
• VIA University College: collaborator
• Research Unit for General Practice, Aarhus University: collaborator
• Copenhagen University Hospital, Hvidovre: collaborator
• Defactum, Central Denmark Region: collaborator

Study Sites (2)

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

Silkeborg Regional Hospital.

Silkeborg, 8600, Denmark

RECRUITING

Related Publications (3)

• 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.

  PMID: 38915128 BACKGROUND

• Jacobsen 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.

  PMID: 36127096 BACKGROUND

• Jacobsen 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.

  PMID: 35820302 BACKGROUND

MeSH Terms

Conditions

Hip Dislocation; Hip Dislocation, Congenital; Motor Activity

Interventions

Exercise; Patient Education as Topic

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Julie S Jacobsen, PhD

  VIA University College

  PRINCIPAL INVESTIGATOR

• Inger Mechlenburg, DMSc

  Aarhus University Hospital

  STUDY DIRECTOR

• Kristian Thorborg, PhD

  Copenhagen University Hospital, Hvidovre

  STUDY CHAIR

• Rasmus Ø Nielsen, PhD

  University of Aarhus

  STUDY CHAIR

• Stig S Jakobsen, PhD

  Aarhus University Hospital

  STUDY CHAIR

• Lisa G Oestergaard, PhD

  Defactum, Central Denmark Region

  STUDY CHAIR

• Kjeld Søballe, PhD

  Aarhus University Hospital

  STUDY CHAIR

Central Study Contacts

Julie S Jacobsen, PhD

CONTACT

4551866165; jsaj@via.dk

Inger Mechlenburg, DMSc

CONTACT

4521679062; inger.mechlenburg@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: March 9, 2021
• First Posted: March 12, 2021
• Study Start: April 16, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication and ending 5 years following primary article publication.
• Access Criteria: Proposals should be directed to jsaj@via.dk. To gain access, data requestors will need to sign a data access agreement.

Locations

DK (2)