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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Group will practice 15 seconds isometric lower limb stretching protocol and must continue practicing running as usual. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the First Injury | How long it takes to a diagnosed running related lower limb injuries to occur | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabel Sacco, PHD | Associate Professor at São Paulo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade de São Paulo | São Paulo | 05360-160 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34786990 | Derived | 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. | |
| 34169063 |
| Label | URL |
|---|---|
| Laboratory website | View source |
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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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after completion of the study.
Upon request.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Group will practice 15 seconds isometric lower limb stretching protocol and must continue practicing running as usual. 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. |
| FG001 | Foot and Ankle Strengthening | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Group will practice 15 seconds isometric lower limb stretching protocol and must continue practicing running as usual. 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 1 year |
|
1 year
Adverse Events was defined as in clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Group will practice 15 seconds isometric lower limb stretching protocol and must continue practicing running as usual. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Isabel Sacco | University of Sao Paulo - School of Medicine | 0055 11 996431511 | icnsacco@usp.br |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2016 | Dec 12, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 1, 2015 | May 16, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| 2 months |
| Foot Muscles Hypertrophy (Volume) | Intrinsic foot muscles volume measured by MRI | 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) | 2 months |
| Foot and Ankle Running Kinematics | medial longitudinal arch range of motion during barefoot running on a treadmill | 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 | 2 months |
| Foot Inversion During Running | Shank to calcaneous inversion angle during barefoot running on a treadmill | 2 months |
| Foot Eversion During Running | Shank to calcaneous eversion angle during barefoot running on a treadmill | 2 months |
| Vertical Loading Rate Force During Running | Vertical loading rate measured on a force platform during subject's runnning | 2 months |
| 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. |
| 33156692 | Derived | 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. |
| 27075480 | Derived | 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. |
| University website | View source |
| Foot and Ankle Strengthening |
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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Running experience (years) | Mean | Standard Deviation | years |
|
|
|
| Secondary | Time to the First Injury | How long it takes to a diagnosed running related lower limb injuries to occur | 25% quartile-estimation of time-to-injury survival time | Posted | Mean | Standard Deviation | months | 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) | 2x2 repeated measures analysis of variance (ANOVA) was used to compare the interaction effect of training (foot strengthening vs. control) and time (T0 and T8). In case of significant interaction effects, Tukey's HSD test was used to conduct pairwise comparisons to identify differences in time, group, or both. | Posted | Mean | Standard Deviation | %bodyweight | 2 months |
|
|
|
| Secondary | Foot Muscles Hypertrophy (Volume) | Intrinsic foot muscles volume measured by MRI | Posted | Mean | Standard Deviation | cm3 | 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) | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
|
|
| Secondary | Foot and Ankle Running Kinematics | medial longitudinal arch range of motion during barefoot running on a treadmill | Posted | Mean | Standard Deviation | degrees | 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 | Posted | Mean | Standard Deviation | *bodyweight | 2 months |
|
|
|
| Secondary | Foot Inversion During Running | Shank to calcaneous inversion angle during barefoot running on a treadmill | Posted | Mean | Standard Deviation | degrees | 2 months |
|
|
|
| Secondary | Foot Eversion During Running | Shank to calcaneous eversion angle during barefoot running on a treadmill | Posted | Mean | Standard Deviation | degrees | 2 months |
|
|
|
| Secondary | Vertical Loading Rate Force During Running | Vertical loading rate measured on a force platform during subject's runnning | Posted | Mean | Standard Deviation | *bodyweight/s | 2 months |
|
|
|
| 0 |
| 61 |
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | Foot and Ankle Strengthening | 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. 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. | 0 | 57 | 0 | 57 | 0 | 57 |
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| abductor digiti minimi volume |
|
| flexor hallucis brevis volume |
|