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Completed

NCT Number: NCT02306148

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade de São Paulo

São Paulo, 05360-160, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Foot and ankle strengthening

Other

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 outcomes

  1. Number of Participants With Running Related Lower Limb Injuries

    Time frame: 1 year

    Diagnosed running related lower limb injuries in recreational runners within 12 months of the study

Secondary outcomes

  1. Time to the First Injury

    Time frame: 12 months

    How long it takes to a diagnosed running related lower limb injuries to occur

  2. Toes and Hallux Muscle Strength

    Time frame: 2 months

    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)

  3. Foot Muscles Hypertrophy (Volume)

    Time frame: 2 months

    Intrinsic foot muscles volume measured by MRI

  4. Foot Health and Functionality

    Time frame: 2 months

    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)

  5. Foot and Ankle Running Kinematics

    Time frame: 2 months

    medial longitudinal arch range of motion during barefoot running on a treadmill

  6. Ground Reaction Forces During Running

    Time frame: 2 months

    Breaking forces (negative values as it is a decceleration force), vertical peak forces (positive values) measured on a force platform during subject's runnning

  7. Foot Inversion During Running

    Time frame: 2 months

    Shank to calcaneous inversion angle during barefoot running on a treadmill

  8. Foot Eversion During Running

    Time frame: 2 months

    Shank to calcaneous eversion angle during barefoot running on a treadmill

  9. Vertical Loading Rate Force During Running

    Time frame: 2 months

    Vertical loading rate measured on a force platform during subject's runnning

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Effects of a Foot Strengthening Program on the Incidence of Injuries, Foot Functionality and Health in Long Distance Runners: a Randomized Controlled Trial.

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 3, 2014
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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