NCT01003756已完成不适用
Preoperative Exercise in Patients Undergoing Total Hip or Knee Replacement
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Change in self reported physical function. Assessed with KOOS/HOOS questionnaire subscale ADL Function
研究概览
简要总结
This study is conducted in the Community Hospital in Svendborg (OUH Svendborg Sygehus) in collaboration with University of Southern Denmark and Odense University Hospital.
The overall purpose of this study is to evaluate the effects of preoperatively delivered neuromuscular exercise on self perceived physical function, pain and Quality of Life in patients undergoing total hip or knee replacement. Secondary area of interest is physical performance, muscle function, and level of physical activity.
The project will be conducted in two phases:
- A pilot project focusing on the logistics of the upcoming randomized controlled trial (RCT) and determination of test-retest reliability of specific muscle strength variables for the patients of interest
- A randomized and controlled trial where the intervention is preoperative neuromuscular exercise and the controls receive standard instructions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective primary, unilateral total hip or knee replacement in Svendborg Community Hospital, Odense University Hospital, Denmark.
- •Patients with osteoarthritis
- •Age over 18
排除标准
- •Not being able to read and understand Danish.
- •Patients with co-morbidity diseases where a moderate level of physical exercise is contraindicated, e.g. severe heart disease and neurological deficits.
- •Patients unable to attend intervention.
- •Rheumatoid arthritis (RA). A history of or ongoing use of medication for RA or other inflammatory arthritis such as gold, methotrexate, plaquenil etc.
- •Lack of wish to participate or unwillingness to sign an informed consent.
- •Specific for hip patients: a history of severe sequelae due to congenital hip-dysplasia requiring specialized postoperative training. A history of femoral neck and trochanteric fracture.
- •Patients planned to have bilateral joint replacement within same procedure.
结局指标
主要结局
Change in self reported physical function. Assessed with KOOS/HOOS questionnaire subscale ADL Function
时间窗: 3 month postoperative (primary endpoint)
Further assessments: baseline, preoperative, 6 weeks postoperative and 1-year follow up
次要结局
- Self reported pain. Assessed with KOOS and HOOS subscale on pain.(baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up)
- Self reported quality of life (Qol). Assessed with KOOS and HOOS sub scale quality of life(baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up)
- Self reported quality of life. Assessed with EQ5D questionnaire(baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up)
- Observed physical function. Assessed with performance measures: 20 meter walk, 5 chair stands timed and one leg knee bendings/30 sec(baseline, one week preop. and 3 month postop.)
- Muscle strength estimated as average muscle power for muscles of the hip and knee(baseline, 1 week preop. and 3 month postop)
研究者
Allan Villadsen
MD
University of Southern Denmark
研究点 (2)
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