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

Primary Purpose

Leg Injuries

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Foot and ankle strengthening
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Leg Injuries

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Foot and ankle strengthening

Arm Description

Group will practice 15 seconds isometric lower limb stretching protocol and must continue practicing running as usual.

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.

Outcomes

Primary Outcome Measures

Lower limbs injuries occurrence
Diagnosed running related lower limb injuries

Secondary Outcome Measures

Time to the first injury
How long it takes to a diagnosed running related lower limb injuries to occur
Foot muscle strength (subject pressing with their toes against a pressure sensor platform)
Outcome measure of a subject pressing with their toes against a pressure sensor platform
foot muscles hypertrophy (foot muscles crosssectional area measured by MRI)
foot muscles crosssectional area measured by MRI
Foot health and functionality (Score of the Foot Health Status questionnaire - BR)
Score of the Foot Health Status questionnaire - BR
Foot and ankle Kinematics during gait (ankle range of motion and maximum ankle flexion angle during gait)
ankle range of motion and maximum ankle flexion angle during gait
Ankle and Knee joint moments during gait (inverse dynamics of the outcome measure of a force platform during subject's gait)
inverse dynamics of the outcome measure of a force platform during subject's gait
Foot Posture Index
A six components measure that allows multiple segment evaluation of foot posture on a static measurement.
Cavanagh Arch Index
Planimetric measures of the foot blueprint that categorizes the foot in high arch, normal arch or flat arch.

Full Information

First Posted
November 28, 2014
Last Updated
October 18, 2019
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02306148
Brief Title
Effects of Foot Strengthening on the Incidence of Injuries in Long Distance Runners
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 Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Injuries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Group will practice 15 seconds isometric lower limb stretching protocol and must continue practicing running as usual.
Arm Title
Foot and ankle strengthening
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Foot and ankle strengthening
Intervention Description
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 Measure Information:
Title
Lower limbs injuries occurrence
Description
Diagnosed running related lower limb injuries
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time to the first injury
Description
How long it takes to a diagnosed running related lower limb injuries to occur
Time Frame
1 week
Title
Foot muscle strength (subject pressing with their toes against a pressure sensor platform)
Description
Outcome measure of a subject pressing with their toes against a pressure sensor platform
Time Frame
2 months
Title
foot muscles hypertrophy (foot muscles crosssectional area measured by MRI)
Description
foot muscles crosssectional area measured by MRI
Time Frame
2 months
Title
Foot health and functionality (Score of the Foot Health Status questionnaire - BR)
Description
Score of the Foot Health Status questionnaire - BR
Time Frame
2 months
Title
Foot and ankle Kinematics during gait (ankle range of motion and maximum ankle flexion angle during gait)
Description
ankle range of motion and maximum ankle flexion angle during gait
Time Frame
2 months
Title
Ankle and Knee joint moments during gait (inverse dynamics of the outcome measure of a force platform during subject's gait)
Description
inverse dynamics of the outcome measure of a force platform during subject's gait
Time Frame
2 months
Title
Foot Posture Index
Description
A six components measure that allows multiple segment evaluation of foot posture on a static measurement.
Time Frame
2 months
Title
Cavanagh Arch Index
Description
Planimetric measures of the foot blueprint that categorizes the foot in high arch, normal arch or flat arch.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel Sacco, PHD
Organizational Affiliation
Associate Professor at São Paulo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05360-160
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All files will be available in the database published at http://figshare.com after completion of the study.
IPD Sharing URL
https://doi.org/10.6084/m9.figshare.10003406.v1
Citations:
PubMed Identifier
34786990
Citation
Suda EY, Watari R, Matias AB, Taddei UT, Sacco ICN. Predictive Effect of Well-Known Risk Factors and Foot-Core Training in Lower Limb Running-Related Injuries in Recreational Runners: A Secondary Analysis of a Randomized Controlled Trial. Am J Sports Med. 2022 Jan;50(1):248-254. doi: 10.1177/03635465211056329. Epub 2021 Nov 17.
Results Reference
derived
PubMed Identifier
34169063
Citation
Watari R, Suda EY, Santos JPS, Matias AB, Taddei UT, Sacco ICN. Subgroups of Foot-Ankle Movement Patterns Can Influence the Responsiveness to a Foot-Core Exercise Program: A Hierarchical Cluster Analysis. Front Bioeng Biotechnol. 2021 Jun 8;9:645710. doi: 10.3389/fbioe.2021.645710. eCollection 2021.
Results Reference
derived
PubMed Identifier
33156692
Citation
Taddei UT, Matias AB, Duarte M, Sacco ICN. Foot Core Training to Prevent Running-Related Injuries: A Survival Analysis of a Single-Blind, Randomized Controlled Trial. Am J Sports Med. 2020 Dec;48(14):3610-3619. doi: 10.1177/0363546520969205. Epub 2020 Nov 6.
Results Reference
derived
PubMed Identifier
27075480
Citation
Matias AB, Taddei UT, Duarte M, Sacco IC. Protocol for evaluating the effects of a therapeutic foot exercise program on injury incidence, foot functionality and biomechanics in long-distance runners: a randomized controlled trial. BMC Musculoskelet Disord. 2016 Apr 14;17:160. doi: 10.1186/s12891-016-1016-9.
Results Reference
derived
Links:
URL
http://www.usp.br/labimph
Description
Laboratory website
URL
http://www.fm.usp.br/
Description
University website

Learn more about this trial

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

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