Role of Shoe Cushioning, Body Mass and Running Biomechanics on Injury Risk: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 874
- 试验地点
- 2
- 主要终点
- Running-related injury (First-time)
研究概览
简要总结
The main goal is to investigate the influence of shoe cushioning and body mass on the risk of running-related injury. This study will allow to determine if shoe cushioning needs to be adapted to the mass of the runner in order to minimize injury risk. The influence of shoe cushioning on running technique will also be investigated.
This study consists in a 6-month follow-up period during which leisure-time runners are required to perform a running activity at least once a week and to upload all their running as well as other sporting activities onto a secured web-based training calendar named "Training and Injury Prevention Platform for Sports" (TIPPS) on a weekly basis. Any injury sustained during this period should also be uploaded onto the TIPPS system using the injury questionnaire provided on the website. Finally, the day of the visit to the laboratory (study start), their running style will be analysed during a 15-minute run on an instrumented treadmill at the participant's usual running speed. Anthropometric measurements will also taken.
Before the beginning of the study, the participants will receive a pair of running shoes free of charge. These shoes will either have a soft or hard sole. Both shoe versions have cushioning properties that correspond to the range of values from the shoes available on the market. They will be administered through random allocation. Neither the participants nor the research team will know which shoe version was provided to the participant, in order to respect the double-blinded methodology of this study. The participants will be required to use these shoes for all running sessions, and only for running activities.
Hypotheses:
H1: Running shoes with greater stiffness are associated with a higher injury risk in leisure-time runners.
H2: High body mass is associated with a higher injury risk in leisure-time runners.
H3: Runners with a high body mass experience a lower injury risk in shoes with greater stiffness.
H4: A higher step length, a lower step frequency, and higher peak vertical impact forces are associated with a higher injury risk.
H5: Running shoes with greater stiffness will be associated with higher vertical impact peak forces and a shorter contact time.
H6: High body mass will be associated with higher peak vertical impact forces, increased contact time, increased duty factor, and decreased step frequency.
详细描述
The design of this study is a randomized controlled trial with an intervention period of six months and a biomechanical analysis of running pattern the day of inclusion in the study. Running footwear is provided by a renowned sport equipment manufacturer working in close collaboration with the Sports Medicine Research Laboratory (SMRL) of the Luxembourg Institute of Health (LIH), which in turn is responsible for the management and execution of the study. Random allocation of the study shoes, recruitment and follow-up of the participants, biomechanical testing, as well as data management and analysis will be carried out by the SMRL. The study design is based on the comparison between 2 running shoe prototypes, which only differ with respect to the cushioning (i.e. stiffness). The cushioning properties of both shoe versions will be within the range of values of models available on the market.
Recruitment:
Participants will be recruited through advertisements in local newspapers and press releases within the Grand-Duchy of Luxembourg during the months of September 2017 to January 2018. The benefits for the participants are strongly highlighted during the recruitment phase, and are as follows: 1) the use of a sports diary developed by the SMRL and called TIPPS (Training and Injury Prevention Platform for Sports, www.tipps.lu) to record all their sporting activities, quantify progress, and keep track of their sport-related injuries, 2) a free pair of running shoes, and 3) a brief report with the results of the biomechanical testing as well as their anthropometric measurements. However participants will be made aware that they will randomly receive one of the 2 study shoe versions to be worn during the observation period for all their running activities.
Registration procedure:
The participants must understand and agree on the randomized design of the study and that they will be allocated to one of the two running shoe groups. Anyone wishing to take part and believing themselves to meet the inclusion criteria will be invited to follow the process described hereafter:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will be stratified according to their sex since body mass depends on sex. Two pre-established randomization list (block size = 40) will be prepared by a statistician not involved in any other part of the study before the beginning of the study. To ensure allocation concealment, the study groups as well as the shoes will be coded and the randomization lists will be uploaded in the TIPPS system by an IT specialist who will not be involved in any other part of the study. The TIPPS system will provide the investigator with a study group code for each participant, according to the randomization lists. The investigator will upload the shoe ID according to shoe size and study group so that a cross validation will be performed by the TIPPS system. The investigators in charge of the recruitment, follow-up and data validity check, as well as the participants, will be blinded regarding the shoe version distributed. The shoe code will be broken after completion of data analysis.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 65 years
- •Agree to perform running training minimum once a week
- •Agree to use of the pair of running shoes delivered by the research team for each running training session, and only for running activities
- •Agree to report all sporting activities, injuries and pains in the electronic system "TIPPS"
- •Signed Informed consent
- •Capable of performing 15 min of consecutive running
排除标准
- •Any contraindication to running training and testing including cardiovascular/respiratory disease or running impeding injury/condition at the time of initial inclusion
- •A history of surgery to the lower limbs or the back region within the previous 12 months or any degenerative conditions
- •The use of insoles for physical activity
- •Any current running-related injury
研究组 & 干预措施
Hard cushioned running shoes
Running shoes with cushioned properties among the hardest of the market benchmark (Stiffness: +/- 90 N/mm)
干预措施: Hard cushioned running shoes (Other)
Soft cushioned running shoes
Running shoes with cushioned properties among the softest of the market benchmark (Stiffness: +/- 57 N/mm)
干预措施: Soft cushioned running shoes (Other)
结局指标
主要结局
Running-related injury (First-time)
时间窗: 6 months
First running-related (training or competition) musculoskeletal pain in the lower limbs that causes a restriction on or stoppage of running for at least 7 days or 3 consecutive scheduled training sessions.
次要结局
- Running-related injury (subsequent)(6 months)
- Vertical Impact Peak Force (N)(Baseline)
- Vertical Average Loading Rate (N/s)(Baseline)
- Leg stiffness (kN/m)(Baseline)
- Vertical stiffness (kN/m)(Baseline)
- Step length (m)(Baseline)
- Peak Vertical Force (N)(Baseline)
- Vertical Instantaneous Loading Rate (N/s)(Baseline)
- Peak Power (W)(Baseline)
- Time to Peak Power (ms)(Baseline)
- Contact time (ms)(Baseline)
- Step frequency (steps/min)(Baseline)
- Flight time (ms)(Baseline)
- Duty factor (%)(Baseline)
研究者
Laurent Malisoux, PhD
Principal Investigator
Luxembourg Institute of Health