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 Musculoskeletal Disorders

Søren Overgaard²  Per Kjærsgaard-Andersen³  Ewa M Roos¹  Carsten Jensen² 

[1] Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense C, Denmark;Institute of Clinical Research, University of Southern Denmark, Odense C, Denmark;Sector for Hip and Knee Replacement, Dept. of Orthopedics, Vejle Hospital, Vejle, Denmark

关键词: Hip replacement;    Hip;    Osteoarthritis;    Education;    Exercise therapy;   

Others  :  1134209
DOI  :  10.1186/1471-2474-14-21

 received in 2012-12-19, accepted in 2013-01-09,  发布年份 2013

【 摘 要 】

Background

The age- and gender-specific incidence of total hip replacement surgery has increased over the last two decades in all age groups. Recent studies indicate that non-surgical interventions are effective in reducing pain and disability, even at later stages of the disease when joint replacement is considered. We hypothesize that the time to hip replacement can be postponed in patients with severe hip osteoarthritis following participation in a patient education and supervised exercise program when compared to patients receiving patient education alone.

Methods/design

A prospective, blinded, parallel-group multi-center trial (2 sites), with balanced randomization [1:1]. Patients with hip osteoarthritis and an indication for hip replacement surgery, aged 40 years and above, will be consecutively recruited and randomized into two treatment groups. The active treatment group will receive 3 months of supervised exercise consisting of 12 sessions of individualized, goal-based neuromuscular training, and 12 sessions of intensive resistance training plus patient education (3 sessions). The control group will receive only patient education (3 sessions). The primary end-point for assessing the effectiveness of the intervention is 12 months after baseline. However, follow-ups will also be performed once a year for at least 5 years. The primary outcome measure is the time to hip replacement surgery measured on a Kaplain-Meier survival curve from time of inclusion. Secondary outcome measures are the five subscales of the Hip disability and Osteoarthritis Outcome Score, physical activity level (UCLA activity score), and patient’s global perceived effect. Other measures include pain after exercise, joint-specific adverse events, exercise adherence, general health status (EQ-5D-5L), mechanical muscle strength and performance in physical tests. A cost-effectiveness analysis will also be performed.

Discussion

To our knowledge, this is the first randomized clinical trial comparing a patient education plus supervised exercise program to patient education alone in hip osteoarthritis patients with an indication for surgery on the time to total hip replacement.

Trial registration

NCT01697241

【 授权许可】

   
2013 Jensen et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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