NCT03115437

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
874

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 20, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

March 30, 2017

Last Update Submit

February 25, 2019

Conditions

Running-Related Injury (First-time)

Keywords

Body massRunning-related injurySports injury preventionImpact forcesEpidemiologyRunning biomechanicsSports footwearShoe cushioning

Outcome Measures

Primary Outcomes (1)

  • Running-related injury (First-time)

    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.

    6 months

Secondary Outcomes (14)

  • Running-related injury (subsequent)

    6 months

  • Step frequency (steps/min)

    Baseline

  • Contact time (ms)

    Baseline

  • Flight time (ms)

    Baseline

  • Duty factor (%)

    Baseline

  • +9 more secondary outcomes

Study Arms (2)

Hard cushioned running shoes

EXPERIMENTAL

Running shoes with cushioned properties among the hardest of the market benchmark (Stiffness: +/- 90 N/mm)

Other: Hard cushioned running shoes

Soft cushioned running shoes

EXPERIMENTAL

Running shoes with cushioned properties among the softest of the market benchmark (Stiffness: +/- 57 N/mm)

Other: Soft cushioned running shoes

Interventions

Hard cushioned running shoesOTHER

The participants allocated to this experimental group will have to perform all their running sessions with the study shoes they received the day of their inclusion to the study and characterized by hard cushioning.

Also known as: Hard
Hard cushioned running shoes
Soft cushioned running shoesOTHER

The participants allocated to this experimental group will have to perform all their running sessions with the study shoes they received the day of their inclusion to the study and characterized by soft cushioning.

Also known as: Soft
Soft cushioned running shoes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luxembourg Institute of Health

Luxembourg, L-1460, Luxembourg

Location

Related Publications (8)

  • Malisoux L, Delattre N, Urhausen A, Morio C, Theisen D. Association of Shoe Cushioning Perception and Comfort With Injury Risk in Leisure-Time Runners: A Secondary Analysis of a Randomised Trial. Eur J Sport Sci. 2025 Nov;25(11):e70063. doi: 10.1002/ejsc.70063.

    PMID: 41122014DERIVED

  • Malisoux L, Gette P, Delattre N, Urhausen A, Theisen D. 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. BMJ Open Sport Exerc Med. 2024 Jan 5;10(1):e001787. doi: 10.1136/bmjsem-2023-001787. eCollection 2024.

    PMID: 38196940DERIVED

  • Malisoux L, Gette P, Delattre N, Urhausen A, Theisen D. Spatiotemporal and Ground-Reaction Force Characteristics as Risk Factors for Running-Related Injury: A Secondary Analysis of a Randomized Trial Including 800+ Recreational Runners. Am J Sports Med. 2022 Feb;50(2):537-544. doi: 10.1177/03635465211063909. Epub 2022 Jan 20.

    PMID: 35049407DERIVED

  • Malisoux L, Gette P, Backes A, Delattre N, Theisen D. Lower impact forces but greater burden for the musculoskeletal system in running shoes with greater cushioning stiffness. Eur J Sport Sci. 2023 Feb;23(2):210-220. doi: 10.1080/17461391.2021.2023655. Epub 2022 Jan 19.

    PMID: 35014593DERIVED

  • Malisoux L, Gette P, Backes A, Delattre N, Cabri J, Theisen D. 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. Front Sports Act Living. 2021 Nov 11;3:744658. doi: 10.3389/fspor.2021.744658. eCollection 2021.

    PMID: 34859204DERIVED

  • Malisoux L, Delattre N, Meyer C, Gette P, Urhausen A, Theisen D. Effect of shoe cushioning on landing impact forces and spatiotemporal parameters during running: results from a randomized trial including 800+ recreational runners. Eur J Sport Sci. 2021 Jul;21(7):985-993. doi: 10.1080/17461391.2020.1809713. Epub 2020 Sep 12.

    PMID: 32781913DERIVED

  • Malisoux L, Delattre N, Urhausen A, Theisen D. Shoe Cushioning Influences the Running Injury Risk According to Body Mass: A Randomized Controlled Trial Involving 848 Recreational Runners. Am J Sports Med. 2020 Feb;48(2):473-480. doi: 10.1177/0363546519892578. Epub 2019 Dec 26.

    PMID: 31877062DERIVED

  • Malisoux L, Delattre N, Urhausen A, Theisen D. Shoe cushioning, body mass and running biomechanics as risk factors for running injury: a study protocol for a randomised controlled trial. BMJ Open. 2017 Aug 21;7(8):e017379. doi: 10.1136/bmjopen-2017-017379.

    PMID: 28827268DERIVED

Related Links

MeSH Terms

Interventions

Hardness

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Study Officials

  • Laurent Malisoux, PhD

    Luxembourg Institute of Health

    PRINCIPAL INVESTIGATOR

  • Daniel Theisen, PhD

    Luxembourg Institute of Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 14, 2017

Study Start

September 20, 2017

Primary Completion

July 31, 2018

Study Completion

October 31, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

The IPD will not be shared.

Locations

LU(1)