Leg InjuriesNCT02306148
Effects of Foot Strengthening on the Incidence of Injuries in Long Distance Runners
A study testing Foot and ankle strengthening in people with Leg Injuries, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Leg Injuries
- What is being tested?
- Foot and ankle strengthening
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2015to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- practice long distance (more than 5 km) running for at least one year;
- run at least 20 km a week;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Leg Injuries
- Being tested
- Foot and ankle strengthening
- Medical subject headings
- Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot and ankle strengtheningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Group will practice 15 seconds isometric lower limb stretching protocol and must continue practicing running as usual. Receives: Other: Foot and ankle strengthening |
| Foot and ankle strengthening | Experimental | Group will be trained during 2 months by a physiotherapist for foot and ankle strengthening and must continue to exercise at home with a training software supervision. Must continue practicing running as usual. Receives: Other: Foot and ankle strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Running Related Lower Limb Injuries
Diagnosed running related lower limb injuries in recreational runners within 12 months of the study
Measured: 1 year
Secondary outcomes (9)
Time to the First Injury
How long it takes to a diagnosed running related lower limb injuries to occur
Measured: 12 months
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)
Measured: 2 months
Foot Muscles Hypertrophy (Volume)
Intrinsic foot muscles volume measured by MRI
Measured: 2 months
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)
Measured: 2 months
Foot and Ankle Running Kinematics
medial longitudinal arch range of motion during barefoot running on a treadmill
Measured: 2 months
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
Measured: 2 months
Foot Inversion During Running
Shank to calcaneous inversion angle during barefoot running on a treadmill
Measured: 2 months
Foot Eversion During Running
Shank to calcaneous eversion angle during barefoot running on a treadmill
Measured: 2 months
Vertical Loading Rate Force During Running
Vertical loading rate measured on a force platform during subject's runnning
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startApr 2015
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Leg InjuriesStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Isabel de Camargo Neves Sacco, University of Sao Paulo General Hospital
- Investigators
- Isabel Sacco, PHD, Principal investigator, Associate Professor at São Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306148
- Sponsor's protocol ID
- LaBiMPH-002
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2014
- Last updated
- 28 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All files are available in the database published at http://figshare.com after completion of the study. All metadata are also available at m https://repositorio.uspdigital.usp.br/
Publications
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.
PubMed 34786990Watari 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.
PubMed 34169063Taddei 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.
PubMed 33156692Matias 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.
PubMed 27075480
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02306148
- Acronym / sponsor ID
- LaBiMPH-002
- Conditions
- Leg Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2015
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Posted 28 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Foot and ankle strengtheningGroup will practice 15 seconds isometric lower limb stretching protocol and must continue practicing running as usual. |
| Foot and ankle strengthening | Experimental | Other: Foot and ankle strengtheningGroup will be trained during 2 months by a physiotherapist for foot and ankle strengthening and must continue to exercise at home with a training software supervision. Must continue practicing running as usual. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- practice long distance (more than 5 km) running for at least one year;
- run at least 20 km a week;
Key exclusion criteria (5 listed)
- 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.
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 and ankle strengtheningGroup will be trained during 2 months at the university by a physiotherapist and at home with a training software for foot and ankle strengthening. | Other | Control Group, Foot and ankle strengthening |
Primary outcome
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
9 secondary outcomes
Time to the First Injury
Time frame: 12 months
Toes and Hallux Muscle Strength
Time frame: 2 months
Foot Muscles Hypertrophy (Volume)
Time frame: 2 months
Foot Health and Functionality
Time frame: 2 months
Foot and Ankle Running Kinematics
Time frame: 2 months
Ground Reaction Forces During Running
Time frame: 2 months
Foot Inversion During Running
Time frame: 2 months
Foot Eversion During Running
Time frame: 2 months
Vertical Loading Rate Force During Running
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34786990Suda 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.
- Derived from this study: PubMed 34169063Watari 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.
- Derived from this study: PubMed 33156692Taddei 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.
- Derived from this study: PubMed 27075480Matias 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.
- Laboratory websiteLink provided by the sponsor.
- University websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All files are available in the database published at http://figshare.com after completion of the study. All metadata are also available at m https://repositorio.uspdigital.usp.br/
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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.
Isabel Sacco, PHD principal investigator
Associate Professor at São Paulo University
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 and ankle strengthening in people with Leg Injuries, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 2 inclusion and 5 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 28 May 2024. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 28 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Running Related Lower Limb Injuries (time frame: 1 year). 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 NCT02306148, 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 28 May 2024.