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

NCT06384872 | Recruiting

• 1 other identifier: 230042_RRI_Interv5
• Study Type: interventional
• Target: 1,068
• Locations: 1 country
• Sites: 1

Brief Summary

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

• 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.

Conditions

Running-related Injury

Keywords

Bodymass; Musculoskeletal; Prevention; Epidemiology; Footwear; Cushioning

Outcome Measures

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.

  6 months

Secondary Outcomes (4)

• First one-day time loss running-related injury

  6 months

• First running-related musculoskeletal complaint to the lower limb

  6 months

• First substantial running-related injury

  6 months

• First overuse running-related injury

  6 months

Study Arms (3)

Hard-Hard cushioned running shoes

EXPERIMENTAL

Running shoes with cushioned properties (linear equivalent stiffness) as follow: about 60 and 80 N/mm at the rear and forepart of the shoe, respectively.

Other: Shoe Cushioning Position and Properties

Soft-Hard cushioned running shoes

EXPERIMENTAL

Running shoes with cushioned properties (linear equivalent stiffness) as follow: about 40 and 80 N/mm at the rear and forepart of the shoe, respectively.

Other: Shoe Cushioning Position and Properties

Soft-Soft cushioned running shoes

EXPERIMENTAL

Running shoes with cushioned properties (linear equivalent stiffness) as follow: about 40 and 50 N/mm at the rear and forepart of the shoe, respectively.

Other: Shoe Cushioning Position and Properties

Interventions

Shoe Cushioning Position and Properties OTHER

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.

Hard-Hard cushioned running shoes; Soft-Hard cushioned running shoes; Soft-Soft cushioned running shoes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women who are pregnant
• 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.

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• DECATHLON SA: collaborator

Study Sites (1)

Luxembourg Institute of Health

Strassen, 1445, Luxembourg

RECRUITING

Related Publications (3)

• Clarsen B, Bahr R, Myklebust G, Andersson SH, Docking SI, Drew M, Finch CF, Fortington LV, Haroy J, Khan KM, Moreau B, Moore IS, Moller M, Nabhan D, Nielsen RO, Pasanen K, Schwellnus M, Soligard T, Verhagen E. Improved reporting of overuse injuries and health problems in sport: an update of the Oslo Sport Trauma Research Center questionnaires. Br J Sports Med. 2020 Apr;54(7):390-396. doi: 10.1136/bjsports-2019-101337. Epub 2020 Feb 14.

  PMID: 32060142 BACKGROUND

• 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: 31877062 BACKGROUND

• Malisoux L, Urhausen A, Flores N, Theisen D, Morio C. Running shoe cushioning properties at the rearfoot and forefoot and their relationship to injury: study protocol for a randomised controlled trial on leisure-time runners. BMJ Open Sport Exerc Med. 2024 Oct 11;10(4):e002217. doi: 10.1136/bmjsem-2024-002217. eCollection 2024.

  PMID: 39415882 DERIVED

Related Links

• Research group webpage
• Project page

Study Officials

• Laurent Malisoux, PhD

  Luxembourg Institute of Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent Malisoux, PhD

CONTACT

26970231; laurent.malisoux@lih.lu

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. 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Group leader

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 25, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1)