Leg Injuries
Conditions
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.
Interventions
OTHERFoot 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.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Running Related Lower Limb Injuries | 1 year | Diagnosed running related lower limb injuries in recreational runners within 12 months of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toes and Hallux Muscle Strength | 2 months | 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) |
| Foot Muscles Hypertrophy (Volume) | 2 months | Intrinsic foot muscles volume measured by MRI |
| Foot Health and Functionality | 2 months | 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) |
| Foot and Ankle Running Kinematics | 2 months | medial longitudinal arch range of motion during barefoot running on a treadmill |
| Time to the First Injury | 12 months | How long it takes to a diagnosed running related lower limb injuries to occur |
| Foot Inversion During Running | 2 months | Shank to calcaneous inversion angle during barefoot running on a treadmill |
| Foot Eversion During Running | 2 months | Shank to calcaneous eversion angle during barefoot running on a treadmill |
| Vertical Loading Rate Force During Running | 2 months | Vertical loading rate measured on a force platform during subject's runnning |
| Ground Reaction Forces During Running | 2 months | Breaking forces (negative values as it is a decceleration force), vertical peak forces (positive values) measured on a force platform during subject's runnning |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 61 |
| 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. | 57 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 12 | 6 |
| Overall Study | Lost to Follow-up | 1 | 4 |
Baseline characteristics
| Characteristic | Control Group | Foot and Ankle Strengthening | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 57 Participants | 118 Participants |
| Age, Continuous | 41.3 years STANDARD_DEVIATION 6.85 | 40.5 years STANDARD_DEVIATION 7.9 | 40.9 years STANDARD_DEVIATION 7.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Brazil | 61 participants | 57 participants | 118 participants |
| Running experience (years) | 6.9 years STANDARD_DEVIATION 5.8 | 5.4 years STANDARD_DEVIATION 4.7 | 6.2 years STANDARD_DEVIATION 5.3 |
| Sex: Female, Male Female | 29 Participants | 29 Participants | 58 Participants |
| Sex: Female, Male Male | 32 Participants | 28 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 57 |
| other Total, other adverse events | 0 / 61 | 0 / 57 |
| serious Total, serious adverse events | 0 / 61 | 0 / 57 |
Outcome results
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
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With Running Related Lower Limb Injuries | 20 Participants |
| Foot and Ankle Strengthening | Number of Participants With Running Related Lower Limb Injuries | 8 Participants |
Secondary
Foot and Ankle Running Kinematics
medial longitudinal arch range of motion during barefoot running on a treadmill
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Foot and Ankle Running Kinematics | 2.88 degrees | Standard Deviation 5.36 |
| Foot and Ankle Strengthening | Foot and Ankle Running Kinematics | 0.17 degrees | Standard Deviation 6.86 |
Secondary
Foot Eversion During Running
Shank to calcaneous eversion angle during barefoot running on a treadmill
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Foot Eversion During Running | 6.39 degrees | Standard Deviation 1.88 |
| Foot and Ankle Strengthening | Foot Eversion During Running | 5.90 degrees | Standard Deviation 2.95 |
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)
Time frame: 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Foot Health and Functionality | General Foot health | 83 units on a scale | Standard Deviation 27.6 |
| Control Group | Foot Health and Functionality | Foot function | 100 units on a scale | Standard Deviation 0 |
| Foot and Ankle Strengthening | Foot Health and Functionality | General Foot health | 92 units on a scale | Standard Deviation 11.6 |
| Foot and Ankle Strengthening | Foot Health and Functionality | Foot function | 100 units on a scale | Standard Deviation 1.7 |
Secondary
Foot Inversion During Running
Shank to calcaneous inversion angle during barefoot running on a treadmill
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Foot Inversion During Running | -3.51 degrees | Standard Deviation 5.7 |
| Foot and Ankle Strengthening | Foot Inversion During Running | -5.74 degrees | Standard Deviation 6.31 |
Secondary
Foot Muscles Hypertrophy (Volume)
Intrinsic foot muscles volume measured by MRI
Time frame: 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Foot Muscles Hypertrophy (Volume) | Abductor Hallucis volume | 13.3 cm3 | Standard Deviation 6.3 |
| Control Group | Foot Muscles Hypertrophy (Volume) | flexor digitorum brevis volume | 13.3 cm3 | Standard Deviation 4.3 |
| Control Group | Foot Muscles Hypertrophy (Volume) | abductor digiti minimi volume | 12.0 cm3 | Standard Deviation 4.6 |
| Control Group | Foot Muscles Hypertrophy (Volume) | flexor hallucis brevis volume | 12.0 cm3 | Standard Deviation 4.1 |
| Foot and Ankle Strengthening | Foot Muscles Hypertrophy (Volume) | flexor hallucis brevis volume | 10.2 cm3 | Standard Deviation 4.4 |
| Foot and Ankle Strengthening | Foot Muscles Hypertrophy (Volume) | Abductor Hallucis volume | 13.7 cm3 | Standard Deviation 6.3 |
| Foot and Ankle Strengthening | Foot Muscles Hypertrophy (Volume) | abductor digiti minimi volume | 11.2 cm3 | Standard Deviation 4.8 |
| Foot and Ankle Strengthening | Foot Muscles Hypertrophy (Volume) | flexor digitorum brevis volume | 12.5 cm3 | Standard Deviation 4.7 |
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
Time frame: 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Ground Reaction Forces During Running | Vertical force peak (BW) | 1.09 *bodyweight | Standard Deviation 0.58 |
| Control Group | Ground Reaction Forces During Running | Peak Breaking force (BW) (negative values as it is a decceleration force) | -0.24 *bodyweight | Standard Deviation 0.05 |
| Foot and Ankle Strengthening | Ground Reaction Forces During Running | Vertical force peak (BW) | 1.14 *bodyweight | Standard Deviation 0.55 |
| Foot and Ankle Strengthening | Ground Reaction Forces During Running | Peak Breaking force (BW) (negative values as it is a decceleration force) | -0.24 *bodyweight | Standard Deviation 0.07 |
Secondary
Time to the First Injury
How long it takes to a diagnosed running related lower limb injuries to occur
Time frame: 12 months
Population: 25% quartile-estimation of time-to-injury survival time
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Time to the First Injury | 10.15 months | Standard Deviation 2.69 |
| Foot and Ankle Strengthening | Time to the First Injury | 7.63 months | Standard Deviation 2.6 |
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)
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Toes and Hallux Muscle Strength | 25.61 %bodyweight | Standard Deviation 7.4 |
| Foot and Ankle Strengthening | Toes and Hallux Muscle Strength | 27.31 %bodyweight | Standard Deviation 9.33 |
Secondary
Vertical Loading Rate Force During Running
Vertical loading rate measured on a force platform during subject's runnning
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Vertical Loading Rate Force During Running | 72.84 *bodyweight/s | Standard Deviation 65.73 |
| Foot and Ankle Strengthening | Vertical Loading Rate Force During Running | 77.17 *bodyweight/s | Standard Deviation 57.52 |