NCT03115437: RRI_Interv4

Effects of Shoe Cushioning and Body Mass on Injury Risk in Running

Completed NA Last updated 26 February 2019

What this trial tests

NA trial testing Hard cushioned running shoes in Running-Related Injury (First-time) in 874 participants. Completed in 31 October 2018.

Timeline

20 September 2017

Primary endpoint
31 July 2018

31 October 2018

Quick facts

Lead sponsor	Luxembourg Institute of Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	874
Start date	20 September 2017
Primary completion	31 July 2018
Estimated completion	31 October 2018
Sites	1 location across Luxembourg

Drugs / interventions tested

• Hard cushioned running shoes
• Soft cushioned running shoes

Conditions studied

• Running-Related Injury (First-time) — all drugs for Running-Related Injury (First-time) →

Sponsor

Luxembourg Institute of Health

Who can join

Adults 18 to 65, any sex, with Running-Related Injury (First-time). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Spatiotemporal and Ground-Reaction Force Characteristics as Risk Factors for Running-Related Injury: A Secondary Analysis of a Randomized Trial Including 800+ Recreational Runners.
   Malisoux L, Gette P, Delattre N, Urhausen A, et al · · 2022 · cited 38× · PMID 35049407 · DOI 10.1177/03635465211063909
2. Shoe Cushioning Influences the Running Injury Risk According to Body Mass: A Randomized Controlled Trial Involving 848 Recreational Runners.
   Malisoux L, Delattre N, Urhausen A, Theisen D. · · 2020 · cited 32× · PMID 31877062 · DOI 10.1177/0363546519892578
3. Effect of shoe cushioning on landing impact forces and spatiotemporal parameters during running: results from a randomized trial including 800+ recreational runners.
   Malisoux L, Delattre N, Meyer C, Gette P, et al · · 2021 · cited 16× · PMID 32781913 · DOI 10.1080/17461391.2020.1809713
4. Shoe cushioning, body mass and running biomechanics as risk factors for running injury: a study protocol for a randomised controlled trial.
   Malisoux L, Delattre N, Urhausen A, Theisen D. · · 2017 · cited 15× · PMID 28827268 · DOI 10.1136/bmjopen-2017-017379
5. Lower impact forces but greater burden for the musculoskeletal system in running shoes with greater cushioning stiffness.
   Malisoux L, Gette P, Backes A, Delattre N, et al · · 2023 · cited 12× · PMID 35014593 · DOI 10.1080/17461391.2021.2023655
6. Relevance of Frequency-Domain Analyses to Relate Shoe Cushioning, Ground Impact Forces and Running Injury Risk: A Secondary Analysis of a Randomized Trial With 800+ Recreational Runners.
   Malisoux L, Gette P, Backes A, Delattre N, et al · · 2021 · cited 8× · PMID 34859204 · DOI 10.3389/fspor.2021.744658
7. Gait asymmetry in spatiotemporal and kinetic variables does not increase running-related injury risk in lower limbs: a secondary analysis of a randomised trial including 800+ recreational runners.
   Malisoux L, Gette P, Delattre N, Urhausen A, et al · · 2024 · cited 5× · PMID 38196940 · DOI 10.1136/bmjsem-2023-001787
8. Reference Values and Determinants of Spatiotemporal and Kinetic Variables in Recreational Runners.
   Malisoux L, Napier C, Gette P, Delattre N, et al · · 2023 · cited 3× · PMID 37868213 · DOI 10.1177/23259671231204629