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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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.

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 Summary:

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.

Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome: Lower limbs injuries occurrence [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Time to the first injury [ Time Frame: 1 week ]
  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) [ Time Frame: 2 months ]
  Outcome measure of a subject pressing with their toes against a pressure sensor platform
• foot muscles hypertrophy (foot muscles crosssectional area measured by MRI) [ Time Frame: 2 months ]
  foot muscles crosssectional area measured by MRI
• Foot health and functionality (Score of the Foot Health Status questionnaire - BR) [ Time Frame: 2 months ]
  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) [ Time Frame: 2 months ]
  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) [ Time Frame: 2 months ]
  inverse dynamics of the outcome measure of a force platform during subject's gait
• Foot Posture Index [ Time Frame: 2 months ]
  A six components measure that allows multiple segment evaluation of foot posture on a static measurement.
• 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.

Original Secondary Outcome:

• Time to the first injury [ Time Frame: 1 week ]
  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) [ Time Frame: 2 months ]
  Outcome measure of a subject pressing with their toes against a pressure sensor platform
• Ankle strength (subject flexing the ankle on a dynamometer) [ Time Frame: 2 months ]
  Outcome measure of a subject flexing the ankle on a dynamometer
• foot muscles hypertrophy (foot muscles crosssectional area measured by MRI) [ Time Frame: 2 months ]
  foot muscles crosssectional area measured by MRI
• Foot health and functionality (Score of the Foot Health Status questionnaire - BR) [ Time Frame: 2 months ]
  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) [ Time Frame: 2 months ]
  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) [ Time Frame: 2 months ]
  inverse dynamics of the outcome measure of a force platform during subject's gait

Information By: University of Sao Paulo General Hospital

Dates:
Date Received: November 28, 2014
Date Started: April 2015
Date Completion: December 2019
Last Updated: May 15, 2017
Last Verified: January 2016