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

October 18, 2019 updated by: Isabel de Camargo Neves Sacco, University of Sao Paulo General Hospital

Effects of a Foot Strengthening Program on the Incidence of Injuries, Foot Functionality and Health in Long Distance Runners: a Randomized Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05360-160
        • Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower limbs injuries occurrence
Time Frame: 1 year
Diagnosed running related lower limb injuries
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to the first injury
Time Frame: 1 week
How long it takes to a diagnosed running related lower limb injuries to occur
1 week
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
2 months
foot muscles hypertrophy (foot muscles crosssectional area measured by MRI)
Time Frame: 2 months
foot muscles crosssectional area measured by MRI
2 months
Foot health and functionality (Score of the Foot Health Status questionnaire - BR)
Time Frame: 2 months
Score of the Foot Health Status questionnaire - BR
2 months
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
2 months
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
2 months
Foot Posture Index
Time Frame: 2 months
A six components measure that allows multiple segment evaluation of foot posture on a static measurement.
2 months
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Isabel Sacco, PHD, Associate Professor at São Paulo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

November 28, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Actual)

October 22, 2019

Last Update Submitted That Met QC Criteria

October 18, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LaBiMPH-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All files will be available in the database published at http://figshare.com after completion of the study.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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