Clinical trial NCT01697241: Effect of Exercise as Non-surgical Treatments on Time to Total Hip Replacement Surgery
Official title: The Effect of Education and Supervised Exercise vs. Education Alone on Time to Total Hip Replacement in Patients With Hip Osteoarthritis Considered Eligible for Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Exercise Therapy
Education
Osteoarthritis
Hip
Hip replacement
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Institute for Clinical Research, Denmark
name: Vejle Hospital
name: Region of Southern Denmark
name: The Danish Rheumatism Association
First posted: 2012-10-02
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to test the hypothesis that patients with severe hip osteoarthritis postpone time to hip replacement surgery following participation in a patient education and supervised exercise program when compared to patients receiving patient education alone.

Detailed description: Hip replacements are performed at an increasing rate, also in younger and less disabled patients. Recent studies indicate non-surgical interventions being effective in reducing pain and disability also at later stages of disease when hip replacement is considered. Possible, non-surgical treatments can be used to postpone hip replacement. The effect of education and supervised exercise on time to hip replacement is largely unknown

Eligibility criteria: Inclusion Criteria:

* 40 years and older
* Indication for total hip arthroplasty
* Residency within local municipal or willing to commute

Exclusion Criteria:

* Inflammatory joint disease
* Earlier ipsilateral proximal femur fracture
* Hip pain \< 3 months
* Neuropathy or neuromuscular disease
* Malignant disease
* Diseases where a moderate level of physical exercise is contraindicated
* Unable to speak or read Danish
* Unable to participate for other reasons
* Refuse to participate

Primary outcomes:
measure: Cumulative Survival analysis (Kaplan-Maier survival curve)
timeFrame: one year
Secondary outcomes:
measure: The Hip disability and Osteoarthritis Outcome Score (HOOS 2.0)
timeFrame: Baseline, 3 and 12 months
measure: University of California Los Angeles activity score (UCLA)
timeFrame: Baseline, 3 and 12 months
measure: Global perceived effect (GPE) score
timeFrame: 3 and 12 months
Other outcomes:
measure: Self-reported exercise pain (VAS-scale)
timeFrame: 3 months
measure: Exercise adherence
timeFrame: 3 months
measure: Cost-effectiveness analysis
timeFrame: 12 months
measure: General health status EuroQol (EQ-5D-5L)
timeFrame: Baseline, 3 and 12 months
measure: Mechanical Muscle Function
timeFrame: Baseline, 3 and 12 months
measure: Physical performance battery
timeFrame: Baseline, 3 and 12 months
measure: Poor compliance
timeFrame: 3 months
measure: Joint specific adverse events
timeFrame: 3 months
Locations:
city: Odense
country: Denmark
facility: Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark
city: Vejle
country: Denmark
facility: Sector for Hip and Knee Replacement, Dept. of Orthopaedics, Vejle Hospital, Denmark
Study officials:
affiliation: Orthopedic Research Unit, Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. Institute of Clinical Research, University of Southern Denmark, Denmark
name: Carsten Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jensen C, Roos EM, Kjaersgaard-Andersen P, Overgaard S. The effect of education and supervised exercise vs. education alone on the time to total hip replacement in patients with severe hip osteoarthritis. A randomized clinical trial protocol. BMC Musculoskelet Disord. 2013 Jan 14;14:21. doi: 10.1186/1471-2474-14-21.