Functional Exercise After Total Hip Replacement: A Randomised Controlled Late Phase Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 主要终点
- WOMAC Western Ontario and Mc Master osteoarthritis index questionaire
研究概览
简要总结
The aim of this research project is to evaluate the efficacy of a specific functional exercise programme to improve pain, stiffness and physical function in patients post total hip replacement from week 12 to week 18 post surgery.
详细描述
This will be a single blind randomised controlled trial with two arms. 70 subjects post primary total hip replacement will be randomised either to a functional; exercise group (n=35) or to a control group following usual care (n=35).
Blinded outcome assessments will be carried out on all subjects by the principal investigator using the Western Ontario and Mc Master arthritis index on day 5 , week 12 aand week 18.
Secondary outcomes measurements will also be collated at week 12 and week 18 including SF 12, 6 min walk test, Dynamometry, and a blinded radiologist will also measure glut med cross sectional area using real time ultrasound at week 12 and week 18.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •12 weeks post primary THR for osteoarthritis
- •Age 50 years and above
- •Able to read and understand and instructions in English
- •Willing to attend classes twice weekly for 8 weeks
- •Able to participate in an exercise programme without physical assistance
- •Able to Mobilize independently 15m without crutches and /or stick -Passed by the referring Orthopaedic Consultant as suitable for inclusion at six week appointment -
排除标准
- •Medically unstable
- •Any central or peripheral nervous system deficits
- •Any underlying terminal disease -Any suspicion of infection following joint replacement -
结局指标
主要结局
WOMAC Western Ontario and Mc Master osteoarthritis index questionaire
时间窗: 3 YEARS
Multi dimensional self administered health status instrument used to measure changes in the dimensions of pain stiffness and function.
次要结局
- Six minute walk test,(3 years)
- Short form SF- 12(3 YEARS)
- HiP Abduction Strength Dynamometry(3 years)
- Real time ultrasound imaging of the gluteus medius muscles(3 years)
研究者
Brenda Monaghan
Principal Investigator Clinical Specialist Physiotherapist
Health Service Executive, Ireland