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

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02306148
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
119
1
2
47
2.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Foot and ankle strengthening
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
119 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 :
Apr 1, 2015
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Lower limbs injuries occurrence [1 year]

    Diagnosed running related lower limb injuries

Secondary Outcome Measures

  1. Time to the first injury [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) [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) [2 months]

    foot muscles crosssectional area measured by MRI

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

    inverse dynamics of the outcome measure of a force platform during subject's gait

  7. Foot Posture Index [2 months]

    A six components measure that allows multiple segment evaluation of foot posture on a static measurement.

  8. Cavanagh Arch Index [2 months]

    Planimetric measures of the foot blueprint that categorizes the foot in high arch, normal arch or flat arch.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidade de São Paulo São Paulo Brazil 05360-160

Sponsors and Collaborators

  • University of Sao Paulo General Hospital
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Isabel de Camargo Neves Sacco, Associate Professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT02306148
Other Study ID Numbers:
  • LaBiMPH-002
First Posted:
Dec 3, 2014
Last Update Posted:
Oct 22, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2019