NCT02306148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

May 28, 2024

Completed
Last Updated

May 28, 2024

Status Verified

December 1, 2023

Enrollment Period

3.9 years

First QC Date

November 28, 2014

Results QC Date

May 16, 2022

Last Update Submit

December 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Time to the First Injury

    12 months

  • Toes and Hallux Muscle Strength

    2 months

  • Foot Muscles Hypertrophy (Volume)

    2 months

  • Foot Health and Functionality

    2 months

  • Foot and Ankle Running Kinematics

    2 months

  • +4 more secondary outcomes

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

Other: Foot and ankle strengthening

Foot and ankle strengthening

EXPERIMENTAL

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

Interventions

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.

Control GroupFoot and ankle strengthening

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de São Paulo

São Paulo, 05360-160, Brazil

Location

Related Publications (4)

  • 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.

Related Links

MeSH Terms

Conditions

Leg Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

Title
Dr Isabel Sacco
Organization
University of Sao Paulo - School of Medicine

Study Officials

  • Isabel Sacco, PHD

    Associate Professor at São Paulo University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 28, 2014

First Posted

December 3, 2014

Study Start

April 1, 2015

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

May 28, 2024

Results First Posted

May 28, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

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/

Time Frame
after completion of the study.
Access Criteria
Upon request.
More information

Locations