Clinical trial NCT02306148: Effects of Foot Strengthening on the Incidence of Injuries in Long Distance Runners
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Injuries
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-12-03
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Running Related Lower Limb Injuries
timeFrame: 1 year
Secondary outcomes:
measure: Time to the First Injury
timeFrame: 12 months
measure: Toes and Hallux Muscle Strength
timeFrame: 2 months
measure: Foot Muscles Hypertrophy (Volume)
timeFrame: 2 months
measure: Foot Health and Functionality
timeFrame: 2 months
measure: Foot and Ankle Running Kinematics
timeFrame: 2 months
measure: Ground Reaction Forces During Running
timeFrame: 2 months
measure: Foot Inversion During Running
timeFrame: 2 months
measure: Foot Eversion During Running
timeFrame: 2 months
measure: Vertical Loading Rate Force During Running
timeFrame: 2 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade de São Paulo
Study officials:
affiliation: Associate Professor at São Paulo University
name: Isabel Sacco, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.