Effect of Exercise as Non-surgical Treatments on Time to Total Hip Replacement Surgery

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: Supervised exercise
* Other: Patient education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised exercise and patient education<br>The entire duration of the intervention is 12 weeks, and consists of 24 sessions each lasting 60-70 minutes. Patients will receive two types of exercises, delivered on separate days. One type of exercise is individualized, goal-based neuromuscular training (NEMEX) in groups with progression guided by the patient's neuromuscular function (12 sessions). The other type of exercise is individualized, intensive resistance training (RT) in groups with each exercise progression guided by load (12 sessions). | Other: Supervised exercise<br>* Patients in the exercise groups will receive two types of exercise, delivered on separate days. One type of exercise is individualized, goal-based neuromuscular training (NEMEX-TJR) in groups with progression guided by the patient's neuromuscular function. The other type of exercise is individualized, intensive resistance training (RT) in groups with each exercise progression guided by load. Each of the two types of exercise will be offered weekly during the 12 week intervention period in sessions lasting 60-70 minutes. Thus, the entire exercise intervention consists of 24 sessions<br>* Other names: NEMEX-TJR and RT;Other: Patient education<br>* The patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration<br>* Other names: BOA;|
| Other: Patient Education<br>The patient education program is designed to educate the patients about hip OA during 3 sessions of 90 min. duration | Other: Patient education<br>* The patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration<br>* Other names: BOA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Survival analysis (Kaplan-Maier survival curve) | Cumulative Survival analysis as time in days without surgery since inclusion | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Hip disability and Osteoarthritis Outcome Score (HOOS 2.0) | HOOS is patient-reported outcome measure with 5 subscales for pain, other symptoms, function in daily living, function in sport and recreation and hip related Quality of Life. A 5-point Likert-scale is used and converted into a 100-point scale with zero indicating the worst possible health (http://www.koos.nu). | Baseline, 3 and 12 months | 
| University of California Los Angeles activity score (UCLA) | Physical activity levels in populations. UCLA is a 10-point likert scale recommended and used extensively in similar populations | Baseline, 3 and 12 months | 
| Global perceived effect (GPE) score | Patients will be asked to rate possible change in their pain, symptoms, ADL, sports and recreation, quality of life, level of physical activity since the initial administration (baseline) on a 7-point Likert-scale. | 3 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise Therapy, Education, Osteoarthritis, Hip, Hip replacement