Osteoarthritis
Conditions
Keywords
Exercise Therapy, Education, Osteoarthritis, Hip, Hip replacement
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
Interventions
OTHERSupervised exercise
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
OTHERPatient education
The patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration
Sponsors
Odense University Hospital
Institute for Clinical Research, Denmark
Vejle Hospital
Region of Southern Denmark
The Danish Rheumatism Association
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Survival analysis (Kaplan-Maier survival curve) | one year | Cumulative Survival analysis as time in days without surgery since inclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Hip disability and Osteoarthritis Outcome Score (HOOS 2.0) | Baseline, 3 and 12 months | 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). |
| University of California Los Angeles activity score (UCLA) | Baseline, 3 and 12 months | Physical activity levels in populations. UCLA is a 10-point likert scale recommended and used extensively in similar populations |
| Global perceived effect (GPE) score | 3 and 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Muscle Function | Baseline, 3 and 12 months | Isometric muscle strength (iMVC) will be collected for knee extensors, hip extensors, -flexors and hip abductors. |
| Physical performance battery | Baseline, 3 and 12 months | Physical performance-based measures will include; 30 s chair stand (number completed), 20 meter fast-paced walk (time in (s)), 30 s single-leg knee bending (number completed), and timed up and go (time in sec.) |
| Self-reported exercise pain (VAS-scale) | 3 months | Pain intensity using the VAS-scale. Participants will be followed for the duration of the exercise intervention (3 months) and be asked to rate pain intensity before and after each exercise session (total 24 sessions) |
| Joint specific adverse events | 3 months | Joint specific adverse events will be determined as: 1) not attending a training session and/or ceasing training because of increased pain/problems in the index joint related to the training; and 2) self-reported exercise pain \> 5 on the VAS-scale after training. The reasons for not attending a session due to pain/problems related to training or to other reasons will be recorded. |
| Poor compliance | 3 months | Reasons for poor compliance will be recorded. |
| Exercise adherence | 3 months | 'The extent to which a person's behavior corresponds with agreed recommendations from a health care provider' using no. of weeks, and no. of completed sessions |
| Cost-effectiveness analysis | 12 months | Cost-effectiveness analysis will be estimated as the ratio between cost of the intervention and the effect it produces. The total cost will be estimated from register-based costing of primary care, secondary care and patient's out-of-pocket costs (transportation expenses and time spent on transportation and receiving health care). Patient-reported values are weighted using Danish tariffs |
| General health status EuroQol (EQ-5D-5L) | Baseline, 3 and 12 months | The EQ-5D is a generic instrument for describing and valuing health. It is based on a descriptive system that defines health in terms of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression (http://www.euroqol.org) |
Countries
Denmark
Outcome results
None listed