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Recruiting Not applicable

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

NCT04795843 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2021-04-16
Last updated
2026-05-15

Condition(s) studied

Hip Dysplasia

Investigational drug(s) / intervention(s)

Exercise and patient educationUsual Care

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * 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) Exclusion Criteria: * 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

Primary outcome measure(s)

  • Change in self-reported pain measured with The Copenhagen Hip and Groin Outcome Score (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 (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.

Trial sites (2)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus N Denmark Recruiting
Silkeborg Regional Hospital. Silkeborg Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04795843 on ClinicalTrials.gov ↗ ← All trials in Denmark