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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Cumulative Survival analysis (Kaplan-Maier survival curve)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years and older
- •Indication for total hip arthroplasty
- •Residency within local municipal or willing to commute
排除标准
- •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
研究组 & 干预措施
Supervised exercise and patient education
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).
干预措施: Supervised exercise (Other)
Supervised exercise and patient education
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).
干预措施: Patient education (Other)
Patient Education
The patient education program is designed to educate the patients about hip OA during 3 sessions of 90 min. duration
干预措施: Patient education (Other)
结局指标
主要结局
Cumulative Survival analysis (Kaplan-Maier survival curve)
时间窗: one year
Cumulative Survival analysis as time in days without surgery since inclusion
次要结局
- The Hip disability and Osteoarthritis Outcome Score (HOOS 2.0)(Baseline, 3 and 12 months)
- University of California Los Angeles activity score (UCLA)(Baseline, 3 and 12 months)
- Global perceived effect (GPE) score(3 and 12 months)
研究者
Carsten Jensen
Assistant Professor
University of Southern Denmark