Effect of Shoe Cushioning Position and Properties on Running-related Injury Risk

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLuxembourg Institute of Health

About this trial

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

1. "Extra soft" cushioning materials can reduce injury risk compared to stiffer materials; 2. Cushioning under the forepart of the shoe also influences injury risk, independently of the cushioning at the rear part; 3. Effects of cushioning material and position depend on the runner's body mass; 4. Perception of cushioning is related to both shoe cushioning and injury risk; 5. 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Shoe Cushioning Position and Properties

    Other intervention

    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, while remaining within the range of values of shoes available on the market (linear equivalent stiffness: about 40 to 60 and 50 to 80 N/mm, at the rear and forepart of the shoe, respectively). We expect a difference in shoe weight lower than 30 g between the three versions (for size 42). The difference in cushioning properties between shoe versions will be created by modifying the type of foam and the foaming process.

Treatment groups

1,068 Participants
are divided into 3 treatment groups
Group A: Hard-Hard cushioned running shoesExperimental treatment 1 intervention
Group B: Soft-Hard cushioned running shoesExperimental treatment 1 intervention
Group C: Soft-Soft cushioned running shoesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

First running-related injury with a duration of minimum one week

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.

Time frame
6 months

Secondary outcomes

1

First one-day time loss running-related injury

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 one day. More specifically, this correspond to injury forms with option 3 or 4 in question 1, or option 1, 2 or 3 in question 2 or question 3 of the OSTRC-O questionnaire, without any minimal duration.

Time frame
6 months
2

First running-related musculoskeletal complaint to the lower limb

Any musculoskeletal complaint including pain, ache, joint instability, stiffness, or any other complaint resulting from participating in running activities, including but irrespective of the need of medical attention (seeking care from medical practitioner) or time-loss (inability to complete a running training session or participate in one or more days after the onset of injury). More specifically, injury forms with option 2 in question 1 of the OSTRC questionnaire will also be considered as outcome of interest in this case.

Time frame
6 months
3

First substantial running-related injury

Injury forms where the participant answered options 3 or 4 in question 2 or question 3 of the OSTRC-O questionnaire.

Time frame
6 months
4

First overuse running-related injury

Injury forms where the participant reported complaints with obvious acute mechanism such as ankle sprain will be excluded (considered as competing risk).

Time frame
6 months

Other outcomes

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