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

Study acronym: RRI_Interv5
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 25, 2026 (before its estimated August 30, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 2 months later Jun 30, 2026 → Aug 30, 2026
See other at-risk trials from Luxembourg Institute of Health

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Enrollment closed, study ongoing
    • Primary and study completion pushed from Jun 30, 2026 to Aug 30, 2026
    • Site details revised
    v6
  2. Minor Primary and study completion dates: Feb 28, 2026 to Jun 30, 2026v5
  3. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 5 more changesShow less
    • Start date: Jan 1, 2025 to Apr 1, 2025
    • Primary and study completion dates: Dec 31, 2025 to Feb 28, 2026
    • Eligibility criteria expanded, about 25 words
    • Study description expanded, about 23 words
    • Site details revised
  4. Notable Start date: Oct 1, 2024 to Jan 1, 2025
    • Primary completion date: Sep 30, 2025 to Dec 31, 2025
    • Study description expanded, about 91 words
    v3
  5. Minor Re-verified, no change to tracked fieldsv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06384872
Lead Sponsor Luxembourg Institute of Health
Collaborators: DECATHLON SA
Conditions
(from sponsor)
Running-related Injury
Enrollment 1,068 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov