An Investigation on Footwear Minimalism and Injury Risk in Runners
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Number of Injury Events
研究概览
简要总结
The following study proposes to investigate the injury risk associated with the use of a new category of running footwear: the minimalist shoe. A group of experienced adult male and female runners with neutral foot types will take part in this study. All participants will be randomized to receive one of three different shoes: a full minimalist shoe (Vibram 5-Fingers), a partial minimalist shoe (Nike Free 3.0) and a conventional neutral supportive running shoe (Nike Pegasus), while training for a 10k event over a 14-week period. Outcomes to be investigated are pain, footwear perception, and number of injury events.
The hypothesizes is that participants using the minimalist footwear during their running program will experience a reduction in running related pain. A greater degree of footwear minimalism will result in a greater reduction in pain (compared to the partial minimalist shoe, Nike Free).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Minimum of 5 years experience running
- •Have been running on a regular basis (minimum once per week) over the past 6 months
- •Able to run for 60 minutes continuously
- •Can tolerate 20-40km per week in training
- •Neutral foot posture according to the Foot Posture Index.
排除标准
- •Have not experienced a running related injury requiring a stoppage of 2-weeks or more in the past 6 months
- •History of surgery to their plantar fascia or Achilles tendon
- •Have already been running in a minimalist shoe
- •Have a diagnosis of osteoarthritis - or other degenerative musculoskeletal disorder - affecting the lower extremity
- •Are currently taking analgesic medication.
结局指标
主要结局
Number of Injury Events
时间窗: 12 weeks
Number of run injury events (defined as unable to complete 3 consecutive running workouts due to running related pain). A calculation of injury incidence will be based on this number after dividing by the number of athletic exposures.
次要结局
- Foot and Ankle Disability Index (FADI)(Week 12)
- Numerical Pain Scale (NPS) for Overall Running Related Pain(Week 12)
- Regional Specific NPS: Shin and Calf Pain(Week 12)
- Regional Specific NPS: Foot and Ankle Pain(12 Week)
- Regional Specific NPS: Knee Pain(12 Weeks)
- Regional Specific NPS: Pelvis and Groin Pain(12 Week)
- Regional Specific NPS: Lower Back Pain(12 Week)