Trial Outcomes & Findings for Effects of Foot Strengthening on the Incidence of Injuries in Long Distance Runners (NCT NCT02306148)
NCT ID: NCT02306148
Last Updated: 2024-05-28
Results Overview
Diagnosed running related lower limb injuries in recreational runners within 12 months of the study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
1 year
Results posted on
2024-05-28
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
57
|
|
Overall Study
COMPLETED
|
48
|
47
|
|
Overall Study
NOT COMPLETED
|
13
|
10
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=61 Participants
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.
|
Foot and Ankle Strengthening
n=57 Participants
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.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=61 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=118 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=61 Participants
|
57 Participants
n=57 Participants
|
118 Participants
n=118 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=61 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=118 Participants
|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 6.85 • n=61 Participants
|
40.5 years
STANDARD_DEVIATION 7.9 • n=57 Participants
|
40.9 years
STANDARD_DEVIATION 7.3 • n=118 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=61 Participants
|
29 Participants
n=57 Participants
|
58 Participants
n=118 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=61 Participants
|
28 Participants
n=57 Participants
|
60 Participants
n=118 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Brazil
|
61 participants
n=61 Participants
|
57 participants
n=57 Participants
|
118 participants
n=118 Participants
|
|
Running experience (years)
|
6.9 years
STANDARD_DEVIATION 5.8 • n=61 Participants
|
5.4 years
STANDARD_DEVIATION 4.7 • n=57 Participants
|
6.2 years
STANDARD_DEVIATION 5.3 • n=118 Participants
|
PRIMARY outcome
Timeframe: 1 yearDiagnosed running related lower limb injuries in recreational runners within 12 months of the study
Outcome measures
| Measure |
Control Group
n=61 Participants
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.
|
Foot and Ankle Strengthening
n=57 Participants
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.
|
|---|---|---|
|
Number of Participants With Running Related Lower Limb Injuries
|
20 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 25% quartile-estimation of time-to-injury survival time
How long it takes to a diagnosed running related lower limb injuries to occur
Outcome measures
| Measure |
Control Group
n=61 Participants
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.
|
Foot and Ankle Strengthening
n=57 Participants
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.
|
|---|---|---|
|
Time to the First Injury
|
10.15 months
Standard Deviation 2.69
|
7.63 months
Standard Deviation 2.60
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: 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.
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)
Outcome measures
| Measure |
Control Group
n=61 Participants
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.
|
Foot and Ankle Strengthening
n=57 Participants
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.
|
|---|---|---|
|
Toes and Hallux Muscle Strength
|
25.61 %bodyweight
Standard Deviation 7.40
|
27.31 %bodyweight
Standard Deviation 9.33
|
SECONDARY outcome
Timeframe: 2 monthsIntrinsic foot muscles volume measured by MRI
Outcome measures
| Measure |
Control Group
n=14 Participants
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.
|
Foot and Ankle Strengthening
n=14 Participants
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.
|
|---|---|---|
|
Foot Muscles Hypertrophy (Volume)
Abductor Hallucis volume
|
13.3 cm3
Standard Deviation 6.3
|
13.7 cm3
Standard Deviation 6.3
|
|
Foot Muscles Hypertrophy (Volume)
flexor digitorum brevis volume
|
13.3 cm3
Standard Deviation 4.3
|
12.5 cm3
Standard Deviation 4.7
|
|
Foot Muscles Hypertrophy (Volume)
abductor digiti minimi volume
|
12.0 cm3
Standard Deviation 4.6
|
11.2 cm3
Standard Deviation 4.8
|
|
Foot Muscles Hypertrophy (Volume)
flexor hallucis brevis volume
|
12.0 cm3
Standard Deviation 4.1
|
10.2 cm3
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 2 monthsScore of the Foot Health Status questionnaire - Brazilian version (domains: function and general foor health) - Scale of FHSQ (0-100 max, the higher the better)
Outcome measures
| Measure |
Control Group
n=61 Participants
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.
|
Foot and Ankle Strengthening
n=57 Participants
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.
|
|---|---|---|
|
Foot Health and Functionality
General Foot health
|
83 units on a scale
Standard Deviation 27.6
|
92 units on a scale
Standard Deviation 11.6
|
|
Foot Health and Functionality
Foot function
|
100 units on a scale
Standard Deviation 0.0
|
100 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 2 monthsmedial longitudinal arch range of motion during barefoot running on a treadmill
Outcome measures
| Measure |
Control Group
n=61 Participants
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.
|
Foot and Ankle Strengthening
n=57 Participants
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.
|
|---|---|---|
|
Foot and Ankle Running Kinematics
|
2.88 degrees
Standard Deviation 5.36
|
0.17 degrees
Standard Deviation 6.86
|
SECONDARY outcome
Timeframe: 2 monthsBreaking forces (negative values as it is a decceleration force), vertical peak forces (positive values) measured on a force platform during subject's runnning
Outcome measures
| Measure |
Control Group
n=41 Participants
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.
|
Foot and Ankle Strengthening
n=46 Participants
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.
|
|---|---|---|
|
Ground Reaction Forces During Running
Vertical force peak (BW)
|
1.09 *bodyweight
Standard Deviation 0.58
|
1.14 *bodyweight
Standard Deviation 0.55
|
|
Ground Reaction Forces During Running
Peak Breaking force (BW) (negative values as it is a decceleration force)
|
-0.24 *bodyweight
Standard Deviation 0.05
|
-0.24 *bodyweight
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: 2 monthsShank to calcaneous inversion angle during barefoot running on a treadmill
Outcome measures
| Measure |
Control Group
n=41 Participants
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.
|
Foot and Ankle Strengthening
n=46 Participants
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.
|
|---|---|---|
|
Foot Inversion During Running
|
-3.51 degrees
Standard Deviation 5.7
|
-5.74 degrees
Standard Deviation 6.31
|
SECONDARY outcome
Timeframe: 2 monthsShank to calcaneous eversion angle during barefoot running on a treadmill
Outcome measures
| Measure |
Control Group
n=41 Participants
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.
|
Foot and Ankle Strengthening
n=46 Participants
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.
|
|---|---|---|
|
Foot Eversion During Running
|
6.39 degrees
Standard Deviation 1.88
|
5.90 degrees
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: 2 monthsVertical loading rate measured on a force platform during subject's runnning
Outcome measures
| Measure |
Control Group
n=41 Participants
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.
|
Foot and Ankle Strengthening
n=46 Participants
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.
|
|---|---|---|
|
Vertical Loading Rate Force During Running
|
72.84 *bodyweight/s
Standard Deviation 65.73
|
77.17 *bodyweight/s
Standard Deviation 57.52
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Foot and Ankle Strengthening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Isabel Sacco
University of Sao Paulo - School of Medicine
Phone: 0055 11 996431511
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place