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

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: Leg Injuries
• Intervention / Treatment: Other: Foot and ankle strengthening

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): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

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

How is the study designed?

Design Details

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

Number of Arms

2

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
Number of Participants With Running Related Lower Limb Injuries	Diagnosed running related lower limb injuries in recreational runners within 12 months of the study	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the First Injury	How long it takes to a diagnosed running related lower limb injuries to occur	12 months
Toes and Hallux Muscle Strength	Outcome measure under the hallux summed to toes while the subject is pressing their toes against a pressure sensor platform (sum of toes and hallux strength)	2 months
Foot Muscles Hypertrophy (Volume)	Intrinsic foot muscles volume measured by MRI	2 months
Foot Health and Functionality	Score of the Foot Health Status questionnaire - Brazilian version (domains: function and general foor health) - Scale of FHSQ (0-100 max, the higher the better)	2 months
Foot and Ankle Running Kinematics	medial longitudinal arch range of motion during barefoot running on a treadmill	2 months
Ground Reaction Forces During Running	Breaking forces (negative values as it is a decceleration force), vertical peak forces (positive values) measured on a force platform during subject's runnning	2 months
Foot Inversion During Running	Shank to calcaneous inversion angle during barefoot running on a treadmill	2 months
Foot Eversion During Running	Shank to calcaneous eversion angle during barefoot running on a treadmill	2 months
Vertical Loading Rate Force During Running	Vertical loading rate measured on a force platform during subject's runnning	2 months

Collaborators and Investigators

• 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

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Laboratory website
• University website

Study record dates

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 (Estimated): December 3, 2014

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries
• 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 are available in the database published at http://figshare.com after completion of the study. All metadata are also available at m https://repositorio.uspdigital.usp.br/
• IPD Sharing Time Frame: after completion of the study.
• IPD Sharing Access Criteria: Upon request.