The Difference Between Rehabilitation With or Without Progressive Strength Training After Fast-track Total Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change from baseline in the maximal distance (in meters) walked in 6 minutes at 2 months after surgery.
研究概览
简要总结
Background and purpose:
In the early phase after a total knee replacement (TKA), patients experience a decrease in leg muscle strength with up to about 80%. This considerable loss of muscle strength is related to reduced functional performance at this point in time. As the loss of muscle strength and functional performance is most pronounced early after TKA, rehabilitation including strength training initiated early after TKA seems a logical choice. However, tradition and fear of symptom exacerbation, such as increased knee joint swelling, knee pain and slow recovery of knee joint range of motion, have typically precluded strength training early after TKA.
Hypothesis:
Our hypothesis is that the effect of early rehabilitation including strength training will be greater than rehabilitation without strength training. If the hypothesis is confirmed, strength training early after TKA could be implemented directly into clinical rehabilitation practice.
Participants and methods:
Seventy participants with a unilateral TKA, between the age of 18 to 80 years, who understand and speak Danish, have given informed consent, will be included in this study.The study is a single-blinded randomized controlled study, where the participants receive supervised 1) rehabilitation with or 2) rehabilitation without strength training in 7 weeks. All components of the rehabilitation program (balance-, and mobility training etc.) are the same in both groups except the strength training exercises. Instead of the strength training exercises, the group without strength training spend more time on warm-up exercises, mobility- and balance exercises. The rehabilitation program lasts 1 hour per session, and will be performed twice per week. The participants perform a test battery 4 times from before to 6 months after the TKA. The test battery assesses the participants' walking ability, leg strength, knee pain, knee joint swelling- and range of motion, and self-reported function and quality of life.
Ethical issues:
From a pilot study conducted in the beginning of 2010, the investigators found, that strength training initiated early after TKA seems feasible, and does not increase knee joint swelling and knee pain. None of the financial supporters, or any of the authors, have any potential conflicts of interest with regard to the study.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a primary unilateral total knee arthroplasty.
- •Age between 18 and 80 years.
- •Participants must understand and speak Danish.
- •Participants undergo surgery at Copenhagen University Hospital, Hvidovre, and live in the counties of Copenhagen, Brøndby or Hvidovre.
排除标准
- •Disease/Musculoskeletal disorder, which requires special rehabilitation modality.
- •Alcohol and drug abuse.
- •Lack of wish to participate or unwillingness to sign an informed consent.
结局指标
主要结局
Change from baseline in the maximal distance (in meters) walked in 6 minutes at 2 months after surgery.
时间窗: Pre-surgery (baseline) and 2 months after surgery (primary endpoint) .
The 6-minute walk test (6MWT) measures the maximal distance a participant is able to walk in 6 minutes between 2 cones placed 29 meters apart from each other. Further assessments: 1 month and 6 months.
次要结局
- Change from baseline in maximum isometric knee-extension and knee-flexion strength at 2 months after surgery.(Pre-surgery (baseline) and 2 months after surgery (primary endpoint).)
- Change from baseline in maximum concentric leg press power at 2 months after surgery.(Pre-surgery (baseline) and 2 months after surgery (primary endpoint).)
- Change from baseline in knee pain during activity and rest at 2 months after surgery.(Pre-surgery (baseline) and 2 months after surgery (primary endpoint).)
- Change from baseline in knee joint swelling at 2 months after surgery.(Pre-surgery (baseline) and 2 months after surgery (primary endpoint).)
- Change from baseline in knee joint range of motion (ROM) at 2 months after surgery.(Pre-surgery (baseline) and 2 months after surgery (primary endpoint).)
- Change from baseline in self-reported quality of life at 2 month after surgery.(Pre-surgery (baseline) and 2 months after surgery (primary endpoint).)
- Change from baseline in self-reported function at 2 months after surgery.(Pre-surgery (baseline) and 2 months after surgery (primary endpoint).)
研究者
Thomas Linding Jakobsen
Research Physiotherapist
Copenhagen University Hospital, Hvidovre
