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Effects of Shoe Cushioning and Body Mass on Injury Risk in Running (RRI_Interv4)

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ClinicalTrials.gov Identifier: NCT03115437
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
DECATHLON SA
Information provided by (Responsible Party):
Laurent Malisoux, PhD, Luxembourg Institute of Health

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.


Condition or disease Intervention/treatment Phase
Running-Related Injury (First-time) Other: Hard cushioned running shoes Other: Soft cushioned running shoes Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Role of Shoe Cushioning, Body Mass and Running Biomechanics on Injury Risk: a Randomized Controlled Trial
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

Arm Intervention/treatment
Experimental: Hard cushioned running shoes
Running shoes with cushioned properties among the hardest of the market benchmark (Stiffness: +/- 90 N/mm)
Other: Hard cushioned running shoes
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.
Other Name: Hard

Experimental: Soft cushioned running shoes
Running shoes with cushioned properties among the softest of the market benchmark (Stiffness: +/- 57 N/mm)
Other: Soft cushioned running shoes
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.
Other Name: Soft




Primary Outcome Measures :
  1. Running-related injury (First-time) [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Running-related injury (subsequent) [ Time Frame: 6 months ]
    Any subsequent 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.

  2. Step frequency (steps/min) [ Time Frame: Baseline ]
    Steps per minute measured during the running technique analysis at baseline

  3. Contact time (ms) [ Time Frame: Baseline ]
    Duration of the contact phase measured during the running technique analysis at baseline

  4. Flight time (ms) [ Time Frame: Baseline ]
    Duration of the flight phase measured during the running technique analysis at baseline

  5. Duty factor (%) [ Time Frame: Baseline ]
    Ratio between contact time and stride time

  6. Step length (m) [ Time Frame: Baseline ]
    Distance between 2 consecutive steps of the same foot calculated based on running speed and stride time

  7. Vertical Impact Peak Force (N) [ Time Frame: Baseline ]
    Amplitude of the first impact peak during the stance phase

  8. Peak Vertical Force (N) [ Time Frame: Baseline ]
    Maximal value of the vertical force during the stance phase

  9. Vertical Instantaneous Loading Rate (N/s) [ Time Frame: Baseline ]
    The steepest slope of the curve of vertical ground reaction force from initial contact to vertical impact peak force

  10. Vertical Average Loading Rate (N/s) [ Time Frame: Baseline ]
    Average increase of vertical force from initial contact to vertical impact peak force

  11. Peak Power (W) [ Time Frame: Baseline ]
    Highest value measure for power during the eccentric phase of the stance phase

  12. Time to Peak Power (ms) [ Time Frame: Baseline ]
    Time from intial contact to peak power

  13. Leg stiffness (kN/m) [ Time Frame: Baseline ]
    Maximal vertical ground reaction force divided by the peak displacement of the leg spring calculated from the initial leg length, running velocity and contact time.

  14. Vertical stiffness (kN/m) [ Time Frame: Baseline ]
    Maximal vertical ground reaction force divided by the vertical displacement of the center of mass



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Any contraindication to running training and testing 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 back region within the previous 12 months or any degenerative conditions
  • The use of insoles for physical activity
  • Any current running-related injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115437


Contacts
Contact: Hélène Agostinis, MSc +35226970890 helene.agostinis@lih.lu

Locations
Luxembourg
Luxembourg Institute of Health Recruiting
Luxembourg, Luxembourg, L-1460
Contact: Hélène Agostinis, MSc    +35226970890    helene.agostinis@lih.lu   
Sponsors and Collaborators
Luxembourg Institute of Health
DECATHLON SA
Investigators
Principal Investigator: Laurent Malisoux, PhD Luxembourg Institute of Health
Study Director: Daniel Theisen, PhD Luxembourg Institute of Health

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laurent Malisoux, PhD, Principal Investigator, Luxembourg Institute of Health
ClinicalTrials.gov Identifier: NCT03115437     History of Changes
Other Study ID Numbers: DOPH_SMRL_20161101
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The IPD will not be shared.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laurent Malisoux, PhD, Luxembourg Institute of Health:
Body mass
Running-related injury
Sports injury prevention
Impact forces
Epidemiology
Running biomechanics
Sports footwear
Shoe cushioning

Additional relevant MeSH terms:
Wounds and Injuries