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Effects of Foot Strengthening on the Incidence of Injuries in Long Distance Runners

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ClinicalTrials.gov Identifier: NCT02306148
Recruitment Status : Recruiting
First Posted : December 3, 2014
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:
The main objective of this trial is to investigate the effects of a training protocol for the foot and ankle complex on the prevalence of running related injuries on long distance runners.

Condition or disease Intervention/treatment Phase
Leg Injuries Other: Foot and ankle strengthening Not Applicable

Detailed Description:

Using a web software as a follow up tool, subjects can be scanned for injuries and have them confirmed by a physician, determining the injuries prevalence in one year.

Through force platform and infrared cameras, the kinematics and kinetics during gait will allow assessment of joint moments, power during propulsion, ankle and knee range of motion.

The hypothesis is that a strengthening program for foot and ankle muscles can alter the prevalence of lower limbs injuries on long distance runners, lowering the harmful forces that these segments receive. The participants will be randomly assigned into control group (placebo intervention) or into intervention group, that will receive an 8 weeks strengthening intervention, twice a week with the supervision of a physiotherapist and three times a week being remotely supervised by a software at home, for 30 minutes each session. This will aim for increasing foot and ankle range of movement and muscle strength.

Every exercise has its own progression depending on the subjects execution, increasing in intensity and difficulty.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effects of a Foot Strengthening Program on the Incidence of Injuries, Foot Functionality and Health in Long Distance Runners: a Randomized Controlled Trial.
Study Start Date : April 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control Group
Group will practice 15 seconds isometric lower limb stretching protocol and must continue practicing running as usual.
Other: Foot and ankle strengthening
Group will be trained during 2 months at the university by a physiotherapist and at home with a training software for foot and ankle strengthening.

Experimental: Foot and ankle strengthening
Group will be trained during 2 months by a physiotherapist for foot and ankle strengthening and must continue to exercise at home with a training software supervision. Must continue practicing running as usual.
Other: Foot and ankle strengthening
Group will be trained during 2 months at the university by a physiotherapist and at home with a training software for foot and ankle strengthening.




Primary Outcome Measures :
  1. Lower limbs injuries occurrence [ Time Frame: 1 year ]
    Diagnosed running related lower limb injuries


Secondary Outcome Measures :
  1. Time to the first injury [ Time Frame: 1 week ]
    How long it takes to a diagnosed running related lower limb injuries to occur

  2. Foot muscle strength (subject pressing with their toes against a pressure sensor platform) [ Time Frame: 2 months ]
    Outcome measure of a subject pressing with their toes against a pressure sensor platform

  3. foot muscles hypertrophy (foot muscles crosssectional area measured by MRI) [ Time Frame: 2 months ]
    foot muscles crosssectional area measured by MRI

  4. Foot health and functionality (Score of the Foot Health Status questionnaire - BR) [ Time Frame: 2 months ]
    Score of the Foot Health Status questionnaire - BR

  5. Foot and ankle Kinematics during gait (ankle range of motion and maximum ankle flexion angle during gait) [ Time Frame: 2 months ]
    ankle range of motion and maximum ankle flexion angle during gait

  6. Ankle and Knee joint moments during gait (inverse dynamics of the outcome measure of a force platform during subject's gait) [ Time Frame: 2 months ]
    inverse dynamics of the outcome measure of a force platform during subject's gait

  7. Foot Posture Index [ Time Frame: 2 months ]
    A six components measure that allows multiple segment evaluation of foot posture on a static measurement.

  8. Cavanagh Arch Index [ Time Frame: 2 months ]
    Planimetric measures of the foot blueprint that categorizes the foot in high arch, normal arch or flat arch.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • practice long distance (more than 5 km) running for at least one year;
  • run at least 20 km a week;

Exclusion Criteria:

  • run using minimalist shoes or barefoot;
  • having prior experience in isolated foot and ankle strength training within the last year;
  • have any health condition that affect gait and running;
  • being receiving any physical therapy intervention;
  • having any running related injuries during the last two months.

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): NCT02306148


Contacts
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Contact: Ulisses Taddei 55-11-30919426 ulisses.taddei@usp.br
Contact: Alessandra Matias alessandra.matias@usp.br

Locations
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Brazil
Universidade de São Paulo Recruiting
São Paulo, Brazil, 05360-160
Contact: Ulisses Taddei, Pt    5511961904340    ulisses.taddei@usp.br   
Contact: Alessandra Matias, Pt    551130918426    alebmatias@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Isabel Sacco, PHD Associate Professor at São Paulo University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02306148     History of Changes
Other Study ID Numbers: LaBiMPH-002
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All files will be available in the database published at http://figshare.com after completion of the study.

Additional relevant MeSH terms:
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Wounds and Injuries
Leg Injuries