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

Leg Injuries Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306148
• Other study ID #: LaBiMPH-002
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: March 1, 2019

Study information

• Verified date: December 2023
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leg Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Brazil	Universidade de São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to the First Injury	How long it takes to a diagnosed running related lower limb injuries to occur	12 months
Secondary	Toes and Hallux Muscle Strength	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)	2 months
Secondary	Foot Muscles Hypertrophy (Volume)	Intrinsic foot muscles volume measured by MRI	2 months
Secondary	Foot Health and Functionality	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)	2 months
Secondary	Foot and Ankle Running Kinematics	medial longitudinal arch range of motion during barefoot running on a treadmill	2 months
Secondary	Ground Reaction Forces During Running	Breaking forces (negative values as it is a decceleration force), vertical peak forces (positive values) measured on a force platform during subject's runnning	2 months
Secondary	Foot Inversion During Running	Shank to calcaneous inversion angle during barefoot running on a treadmill	2 months
Secondary	Foot Eversion During Running	Shank to calcaneous eversion angle during barefoot running on a treadmill	2 months
Secondary	Vertical Loading Rate Force During Running	Vertical loading rate measured on a force platform during subject's runnning	2 months

External Links

•   Laboratory website
•   University website