HealthyNCT05992129

Influence of Foot Types on Collegiate Athletes

A study testing foot exercise in people with Healthy, run by Universidad del Magdalena at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of the study is to assess whether high or low arch foot types influence the overall performance of the athlete. Read more about this study

Who is it for?: Ages 18 to 26 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: foot exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 97 participants
Where: 1 siteColombia
Study dates: 1 Aug 2022to 19 May 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 26 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

University athletes with 4 years of continuous training
high foot
low foot.
Neutral foot

Who cannot join

Any pain
active injuries
biomechanical alteration in their lower extremities.
Spine disorders
Spine surgery
abdominal surgery,

Show all 10Show fewer

neural or vestibular disease
arthritis of the lower extremities
used of alcohol, sedatives, pain relievers, cold medication, or stimulants in the last year
rigid pronated foot

Trial locations and contacts

1 site in 1 country.

Colombia1 site

Universidad del Magdalena
Santa Marta, Magdalena Department, 571

Other trials in Colombia

About this study

Official title: Structural Foot Types and Their Influence on Core Strength and Athletic Performance in Collegiate Athletes

The purpose of the study is to assess whether high or low arch foot types influence the overall performance of the athlete.

Read the detailed description

After meeting the eligibility criteria for the study, university athletes have their general athletic condition variables evaluated in the laboratory and in the field. Subsequently, athletes with high and low arches perform 12-week foot muscle strengthening exercises to re-evaluate the variables in both athletes with high and low arch types who performed the strengthening exercises, as well as those with neutral arch who did not perform the exercises.

Conditions: Healthy
Being tested: foot exercise
Keywords: low foot, high foot, performance, core

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

foot exerciseOther
These are foot and ankle muscle strengthening exercises described and evaluated by the literature

Study groups in NCT05992129
Study group	Role	What they receive
structural foot types and their influence on core in collegiate athletes	Other	Athletes do 12 weeks of exercises and then evaluate how they influenced core stability Receives: Other: foot exercise
structural foot types and their influence on performance in collgiate athletes	Other	Athletes do 12 weeks of exercises and then evaluate how they influenced on sport performance Receives: Other: foot exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Alterations change from baseline of the muscles of the center of gravity at 12 weeks
Measurement of the activity of the muscles of the center of gravity with electromyography
1. Voltage amplitude of the anterior rectus muscle measured in millivolts
2. Erector spinae muscle voltage amplitude measured in millivolts
3. Voltage amplitude of the external oblique muscle measured in millivolts
4. Voltage amplitude of the Internal oblique muscle measured in millivolts
Electrodes were placed on the subjects according to literature recommendations (Oliva-Lozano \& Muyor, 2020). Three sets of three exercise repetitions were performed (García-Vaquero et al., 2012).
Measured: Baseline and week 12
Alterations change from baseline of static stability: total mean distance, Anterioposterior distance and mediolateral distance at 12 weeks
The static stability in terms of total mean distance, Anterioposterior distance and mediolateral distance were measured in millimeters.
The stability was measured when the athlete stood on the dominant leg trying to maintain balance for 10 seconds.
Measured: Baseline and week 12
Alterations change from baseline of static stability: total mean speed, anterio-posterior speed and mediolateral speed at 12 weeks
The static stability in terms of static stability: total mean speed, anterio-posterior speed and mediolateral speed were measured in millimeters/seconds The stability was measured when the athlete stood on the dominant leg trying to maintain balance for 10 seconds.
Measured: Baseline and week 12
Alterations change from baseline of static stability: covered area at 12 weeks
The static stability in terms of static covered area was measured in millimeters² The stability was measured when the athlete stood on the dominant leg trying to maintain balance for 10 seconds.
Measured: Baseline and week 12
Alterations change from baseline of dynamic stability: mean power at 12 weeks
The dynamic stability in terms of mean power was measured in watts/kilogram
The participants were instructed to perform five single-leg jumps using their dominant foot.
Measured: Baseline and week 12
Alterations change from baseline of dynamic stability: left-right and forward/backward displacement at 12 weeks
The dynamic stability in terms of left-right and forward/backward displacement were measured in centimeters The participants were instructed to perform five single-leg jumps using their dominant foot.
Measured: Baseline and week 12
Alterations change from baseline of dynamic stability: covered area at 12 weeks
The dynamic stability in terms of covered area measured in centimeters² The participants were instructed to perform five single-leg jumps using their dominant foot.
Measured: Baseline and week 12
Alterations change from baseline in sport performance of maximum oxygen consumption (VO2max) and anaerobic threshold (AT) at 12 weeks
We used an Ergospirometry system to assess:
VO2max and AT measured in milliliters/kilogram/minute
They followed Marcos' protocol for a continuous treadmill exercise test (Marcos et al., 2018) and estimated VO2max and AT.
Measured: Baseline and week 12
Alterations change from baseline in sport performance of countermovement jump test: maximum force measured at 12 weeks
Sport performance of countermovement jump test: maximum force measured in Newton/kilogram.
For the countermovement jump (CMJ), participants started upright, knees and hips flexed, and then jumped while crossing their hands behind their back (Bobbert et al., 1996).
Measured: Baseline and week 12
Alterations change from baseline in sport performance of countermovement jump test: rate of force development at 12 weeks
Sport performance of countermovement jump test: rate of force development measured in Newton/kilogram/second.
For the countermovement jump (CMJ), participants started upright, knees and hips flexed, and then jumped while crossing their hands behind their back (Bobbert et al., 1996).
Measured: Baseline and week 12
Alterations change from baseline in sport performance of countermovement jump test: maximum power at 12 weeks
Sport performance of countermovement jump test: maximum power measured in Watts/kilogram.
For the countermovement jump (CMJ), participants started upright, knees and hips flexed, and then jumped while crossing their hands behind their back (Bobbert et al., 1996).
Measured: Baseline and week 12
Alterations change from baseline in sport performance of countermovement jump test:maximum velocity at 12 weeks
Sport performance of countermovement jump test: maximum velocity measured in meters/second.
For the countermovement jump (CMJ), participants started upright, knees and hips flexed, and then jumped while crossing their hands behind their back (Bobbert et al., 1996).
Measured: Baseline and week 12
Alterations change from baseline in sport performance of record time 40-meter sprint test at 12 weeks
Sport performance of of 40-meter sprint test: record time measured in seconds. To measure the 40-meter sprint, photocell sensors and biomechanical equipment were used and participants ran at their maximum speed over a distance of 40 meters
Measured: Baseline and week 12
Alterations change from baseline in sport performance of speed 40-meter sprint test at 12 weeks
Sport performance of of 40-meter sprint test: speed measured in meters/second. To measure the 40-meter sprint, photocell sensors and biomechanical equipment were used and participants ran at their maximum speed over a distance of 40 meters
Measured: Baseline and week 12
Alterations change from baseline in sport performance of acceleration 40-meter sprint test at 12 weeks
Sport performance of of 40-meter sprint test: acceleration measured in meters/second².
To measure the 40-meter sprint, photocell sensors and biomechanical equipment were used and participants ran at their maximum speed over a distance of 40 meters
Measured: Baseline and week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202219 May 2023

First posted15 Aug 2023
Study start1 Aug 2022
Primary completion21 Dec 2022
Study completion19 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: After initial measurements of dependent variables (electromyographic activity amplitude of core muscles, static stability, dynamic stability, ergospirometry, countermovement jump, and 40m sprint test), athletes are divided into two groups: 1) Case group, which is further classified into (a) athletes with high arched feet and (b) athletes with flat feet, and 2) Control group, consisting of athletes with neutral feet. The case group performs intrinsic and extrinsic foot muscle strengthening exercises for 12 weeks, while the control group does not engage in these exercises. Following intervention, both case and control groups are re-evaluated in dependent variables to conduct pre-post intervention variable comparisons.
Masking: None (open label)
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05992129
Sponsor's protocol ID: CTUM212170
Status last verified: Aug 2023
First submitted: 14 Jul 2023
Last updated: 15 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Oliva-Lozano JM, Muyor JM. Core Muscle Activity During Physical Fitness Exercises: A Systematic Review. Int J Environ Res Public Health. 2020 Jun 16;17(12):4306. doi: 10.3390/ijerph17124306.
PubMed 32560185
Garcia-Vaquero MP, Moreside JM, Brontons-Gil E, Peco-Gonzalez N, Vera-Garcia FJ. Trunk muscle activation during stabilization exercises with single and double leg support. J Electromyogr Kinesiol. 2012 Jun;22(3):398-406. doi: 10.1016/j.jelekin.2012.02.017. Epub 2012 Mar 20.
PubMed 22436839
Marcos MA, Koulla PM, Anthos ZI. Preseason Maximal Aerobic Power in Professional Soccer Players Among Different Divisions. J Strength Cond Res. 2018 Feb;32(2):356-363. doi: 10.1519/JSC.0000000000001810.
PubMed 29369953
Bobbert MF, Gerritsen KG, Litjens MC, Van Soest AJ. Why is countermovement jump height greater than squat jump height? Med Sci Sports Exerc. 1996 Nov;28(11):1402-12. doi: 10.1097/00005768-199611000-00009.
PubMed 8933491

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Structural Foot Types and Their Influence on Core Strength and Athletic Performance in Collegiate Athletes
ClinicalTrials.gov ID: NCT05992129
Acronym / sponsor ID: CTUM212170
Conditions: Healthy
Keywords: low foot, high foot, performance, core
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: Universidad del MagdalenaUniversity, hospital or other
Study start: 1 Aug 2022 (actual)
Primary completion: 21 Dec 2022 (actual)
Study completion: 19 May 2023 (actual)
First posted: 15 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to assess whether high or low arch foot types influence the overall performance of the athlete.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: After initial measurements of dependent variables (electromyographic activity amplitude of core muscles, static stability, dynamic stability, ergospirometry, countermovement jump, and 40m sprint test), athletes are divided into two groups: 1) Case group, which is further classified into (a) athletes with high arched feet and (b) athletes with flat feet, and 2) Control group, consisting of athletes with neutral feet. The case group performs intrinsic and extrinsic foot muscle strengthening exercises for 12 weeks, while the control group does not engage in these exercises. Following intervention, both case and control groups are re-evaluated in dependent variables to conduct pre-post intervention variable comparisons.

Arm	Type	Receives
structural foot types and their influence on core in collegiate athletes	Other	Other: foot exerciseAthletes do 12 weeks of exercises and then evaluate how they influenced core stability
structural foot types and their influence on performance in collgiate athletes	Other	Other: foot exerciseAthletes do 12 weeks of exercises and then evaluate how they influenced on sport performance

Who may qualify

Ages: 18 to 26 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

University athletes with 4 years of continuous training
high foot
low foot.
Neutral foot

Key exclusion criteria (10 listed)

Any pain
active injuries
biomechanical alteration in their lower extremities.
Spine disorders
Spine surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
foot exerciseThese are foot and ankle muscle strengthening exercises described and evaluated by the literature	Other	structural foot types and their influence on core in collegiate athletes, structural foot types and their influence on performance in collgiate athletes

Primary outcome

Alterations change from baseline of the muscles of the center of gravity at 12 weeks
Time frame: Baseline and week 12
Measurement of the activity of the muscles of the center of gravity with electromyography 1. Voltage amplitude of the anterior rectus muscle measured in millivolts 2. Erector spinae muscle voltage amplitude measured in millivolts 3. Voltage amplitude of the external oblique muscle measured in millivolts 4. Voltage amplitude of the Internal oblique muscle measured in millivolts Electrodes were placed on the subjects according to literature recommendations (Oliva-Lozano \& Muyor, 2020). Three sets of three exercise repetitions were performed (García-Vaquero et al., 2012).
Alterations change from baseline of static stability: total mean distance, Anterioposterior distance and mediolateral distance at 12 weeks
Time frame: Baseline and week 12
The static stability in terms of total mean distance, Anterioposterior distance and mediolateral distance were measured in millimeters. The stability was measured when the athlete stood on the dominant leg trying to maintain balance for 10 seconds.
Alterations change from baseline of static stability: total mean speed, anterio-posterior speed and mediolateral speed at 12 weeks
Time frame: Baseline and week 12
The static stability in terms of static stability: total mean speed, anterio-posterior speed and mediolateral speed were measured in millimeters/seconds The stability was measured when the athlete stood on the dominant leg trying to maintain balance for 10 seconds.
Alterations change from baseline of static stability: covered area at 12 weeks
Time frame: Baseline and week 12
The static stability in terms of static covered area was measured in millimeters² The stability was measured when the athlete stood on the dominant leg trying to maintain balance for 10 seconds.
Alterations change from baseline of dynamic stability: mean power at 12 weeks
Time frame: Baseline and week 12
The dynamic stability in terms of mean power was measured in watts/kilogram The participants were instructed to perform five single-leg jumps using their dominant foot.
Alterations change from baseline of dynamic stability: left-right and forward/backward displacement at 12 weeks
Time frame: Baseline and week 12
The dynamic stability in terms of left-right and forward/backward displacement were measured in centimeters The participants were instructed to perform five single-leg jumps using their dominant foot.
Alterations change from baseline of dynamic stability: covered area at 12 weeks
Time frame: Baseline and week 12
The dynamic stability in terms of covered area measured in centimeters² The participants were instructed to perform five single-leg jumps using their dominant foot.
Alterations change from baseline in sport performance of maximum oxygen consumption (VO2max) and anaerobic threshold (AT) at 12 weeks
Time frame: Baseline and week 12
We used an Ergospirometry system to assess: VO2max and AT measured in milliliters/kilogram/minute They followed Marcos' protocol for a continuous treadmill exercise test (Marcos et al., 2018) and estimated VO2max and AT.
Alterations change from baseline in sport performance of countermovement jump test: maximum force measured at 12 weeks
Time frame: Baseline and week 12
Sport performance of countermovement jump test: maximum force measured in Newton/kilogram. For the countermovement jump (CMJ), participants started upright, knees and hips flexed, and then jumped while crossing their hands behind their back (Bobbert et al., 1996).
Alterations change from baseline in sport performance of countermovement jump test: rate of force development at 12 weeks
Time frame: Baseline and week 12
Sport performance of countermovement jump test: rate of force development measured in Newton/kilogram/second. For the countermovement jump (CMJ), participants started upright, knees and hips flexed, and then jumped while crossing their hands behind their back (Bobbert et al., 1996).
Alterations change from baseline in sport performance of countermovement jump test: maximum power at 12 weeks
Time frame: Baseline and week 12
Sport performance of countermovement jump test: maximum power measured in Watts/kilogram. For the countermovement jump (CMJ), participants started upright, knees and hips flexed, and then jumped while crossing their hands behind their back (Bobbert et al., 1996).
Alterations change from baseline in sport performance of countermovement jump test:maximum velocity at 12 weeks
Time frame: Baseline and week 12
Sport performance of countermovement jump test: maximum velocity measured in meters/second. For the countermovement jump (CMJ), participants started upright, knees and hips flexed, and then jumped while crossing their hands behind their back (Bobbert et al., 1996).
Alterations change from baseline in sport performance of record time 40-meter sprint test at 12 weeks
Time frame: Baseline and week 12
Sport performance of of 40-meter sprint test: record time measured in seconds. To measure the 40-meter sprint, photocell sensors and biomechanical equipment were used and participants ran at their maximum speed over a distance of 40 meters
Alterations change from baseline in sport performance of speed 40-meter sprint test at 12 weeks
Time frame: Baseline and week 12
Sport performance of of 40-meter sprint test: speed measured in meters/second. To measure the 40-meter sprint, photocell sensors and biomechanical equipment were used and participants ran at their maximum speed over a distance of 40 meters
Alterations change from baseline in sport performance of acceleration 40-meter sprint test at 12 weeks
Time frame: Baseline and week 12
Sport performance of of 40-meter sprint test: acceleration measured in meters/second². To measure the 40-meter sprint, photocell sensors and biomechanical equipment were used and participants ran at their maximum speed over a distance of 40 meters

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
Background: PubMed 32560185Oliva-Lozano JM, Muyor JM. Core Muscle Activity During Physical Fitness Exercises: A Systematic Review. Int J Environ Res Public Health. 2020 Jun 16;17(12):4306. doi: 10.3390/ijerph17124306.
Background: PubMed 22436839Garcia-Vaquero MP, Moreside JM, Brontons-Gil E, Peco-Gonzalez N, Vera-Garcia FJ. Trunk muscle activation during stabilization exercises with single and double leg support. J Electromyogr Kinesiol. 2012 Jun;22(3):398-406. doi: 10.1016/j.jelekin.2012.02.017. Epub 2012 Mar 20.
Background: PubMed 29369953Marcos MA, Koulla PM, Anthos ZI. Preseason Maximal Aerobic Power in Professional Soccer Players Among Different Divisions. J Strength Cond Res. 2018 Feb;32(2):356-363. doi: 10.1519/JSC.0000000000001810.
Background: PubMed 8933491Bobbert MF, Gerritsen KG, Litjens MC, Van Soest AJ. Why is countermovement jump height greater than squat jump height? Med Sci Sports Exerc. 1996 Nov;28(11):1402-12. doi: 10.1097/00005768-199611000-00009.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

orlando santiago Moreno barriga principal investigator

Universidad del Magdalena

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing foot exercise in people with Healthy, run by Universidad del Magdalena at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alterations change from baseline of the muscles of the center of gravity at 12 weeks (time frame: Baseline and week 12). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05992129, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.