Effect of Foam Properties and Cushioning Position of Running Shoes on Injury Risk in Leisure-time Runners: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,068
- 试验地点
- 2
- 主要终点
- First running-related injury with a duration of minimum one week
研究概览
简要总结
The main purpose of this project is to investigate the influence of cushioning material at both the rear and the forepart of running shoes on musculoskeletal complaints in leisure-time runners. Therefore, the objectives are to investigate if
- "Extra soft" cushioning materials can reduce injury risk compared to stiffer materials;
- Cushioning under the forepart of the shoe also influences injury risk, independently of the cushioning at the rear part;
- Effects of cushioning material and position depend on the runner's body mass;
- Perception of cushioning is related to both shoe cushioning and injury risk;
- Other weight-bearing locomotion activities (i.e., number of steps per day besides running practice) represents an independent risk factor for running-related injury.
This study consists in a 6-month intervention trial during which leisure-time runners are required to follow their usual training schedule. Before the beginning of the study, the participants will receive a pair of running shoes. The three running shoe models will be exactly the same, except for their foam properties at the rear and forepart of the shoe, which will differ by 33 and 37%, respectively. The study shoes will be administered through random allocation. The participants will be required to use these shoes for all running sessions, and only for running activities.
Participants will first fill out a baseline questionnaire. During the intervention, data on running practice will be downloaded from sports watches via their respective app. Information on the use of the study shoes will be collected via a weekly questionnaire. Participants will be asked to fill out a weekly questionnaire on any musculoskeletal complaints experienced during the past 7 days. A questionnaire on the perception of cushioning will be filled in by the participants at three time points (after 5h of running, 25h of running, and at the end of follow-up).
Primary hypothesis:
- Greater shock absorption properties at the rear part of running shoes are associated with a lower injury risk in recreational runners.
Secondary hypothesis:
- Greater shock absorption properties under the forepart of the shoe are also associated with lower injury risk in recreational runners.
- Runners with low body mass experience a lower injury risk in shoes with greater shock absorption properties.
- Greater perceived cushioning is related to lower injury risk.
详细描述
Study design:
The design of this study is a randomized trial with an intervention period of six months. Running footwear is provided by a renowned sport equipment manufacturer working in close collaboration with the Physical Activity, Sport and Health (PASH) research group of the Luxembourg Institute of Health (LIH). PASH will be responsible for the management and execution of the study, including random allocation of the study shoes, recruitment and follow-up of the participants, as well as data management and analysis. The study design is based on the comparison of three running shoe versions, which differ with respect to their foam properties and cushioning position (i.e., rear and forepart of the shoe). The cushioning properties at the rear and forepart of the three shoe versions will be within the range of values of models available on the market.
Participants:
Healthy leisure-time runners will be recruited through advertising in local newspapers and press releases within Luxembourg, as well as via social media during the months of March 2025 to August 2025. The benefits for the participants are highlighted during the recruitment phase, and are as follows: 1) a free pair of running shoes, and 2) a brief report on the main findings of the study. However, participants will be made aware that they will randomly receive one of the three study shoe versions to be worn during the intervention period for all their running activities.
Volunteers willing to take part in the study 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. Two pre-established randomization list 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 electronic system by an IT specialist who will not be involved in any other part of the study. The electronic 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 electronic 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
- •Willing to use the study shoes for each running training session, and only for running activities
- •Use a sports watch for training data recording
- •Accept to give access to running data via a Garmin Connect, Polar Flow or Suunto account, or accept to upload the GPX file (downloaded from another system) into the electronic system "STRIDE" for every running session
- •Signed electronic Informed Consent provided
排除标准
- •Women who are pregnant
- •Any contraindication to running training 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 lower back within the previous 12 months or any degenerative conditions;
- •The use of orthopedic insoles for physical activity;
- •Any running injury (a physical pain or complaint related to running practice that causes the runner to interrupt or modify his/her training for at least one week) over the last month.
- •No limitation will be set regarding running experience, running level (performance), body mass or body mass index.
结局指标
主要结局
First running-related injury with a duration of minimum one week
时间窗: 6 months
First running-related injury occurring during the follow-up, and defined as any running-related physical complaint in the lower limbs or lower back region that causes a restriction on or stoppage of running (distance, speed, duration, or training) for at least seven days. Practically, this corresponds to injury forms where the participant answered option 3 or 4 in question 1, or option 1, 2 or 3 in question 2 or question 3 of the OSTRC-O questionnaire, with a duration of minimum one week.
次要结局
- First one-day time loss running-related injury(6 months)
- First substantial running-related injury(6 months)
- First running-related musculoskeletal complaint to the lower limb(6 months)
- First overuse running-related injury(6 months)
研究者
Laurent Malisoux, PhD
Group leader
Luxembourg Institute of Health