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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Institute for Clinical Research, Denmark | INDUSTRY |
| Vejle Hospital | OTHER |
| Region of Southern Denmark |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supervised exercise and patient education | Experimental | 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). |
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| Patient Education | Other | The patient education program is designed to educate the patients about hip OA during 3 sessions of 90 min. duration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised exercise | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Survival analysis (Kaplan-Maier survival curve) | Cumulative Survival analysis as time in days without surgery since inclusion | one year |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported exercise pain (VAS-scale) | 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) | 3 months |
| Exercise adherence |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carsten Jensen, PhD | Orthopedic Research Unit, Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. Institute of Clinical Research, University of Southern Denmark, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark | Odense | 5200 | Denmark | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23311889 | Derived | 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. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| OTHER |
| The Danish Rheumatism Association | OTHER |
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| Patient education | Other | The patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration |
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| 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 |
'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 |
| 3 months |
| Cost-effectiveness analysis | 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 | 12 months |
| General health status EuroQol (EQ-5D-5L) | 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) | Baseline, 3 and 12 months |
| Mechanical Muscle Function | Isometric muscle strength (iMVC) will be collected for knee extensors, hip extensors, -flexors and hip abductors. | Baseline, 3 and 12 months |
| Physical performance battery | 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.) | Baseline, 3 and 12 months |
| Poor compliance | Reasons for poor compliance will be recorded. | 3 months |
| Joint specific adverse events | 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. | 3 months |
| Sector for Hip and Knee Replacement, Dept. of Orthopaedics, Vejle Hospital, Denmark |
| Vejle |
| 7100 |
| Denmark |