Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001450808
Ethics application status
Approved
Date submitted
23/03/2021
Date registered
25/10/2021
Date last updated
16/03/2023
Date data sharing statement initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the efficacy of training in minimalist footwear and short foot muscles exercises in long distance runners.
Scientific title
Evaluation of the efficacy of training in minimalist footwear and short foot muscles exercises on muscle activity, load balance and distribution and risk of injury in long distance runners.
Secondary ID [1] 303771 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
injury 321264 0
tissue overload 321265 0
instability 321266 0
Condition category
Condition code
Musculoskeletal 319040 319040 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 319041 319041 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the experimental group, the measurements will be performed four times: at the beginning of the project, after 8 weeks, after 12 weeks and after 20 weeks. At this time (over the 20 weeks), participants will perform running training, with frequency of 3-5 x 1 hour sessions per week. Running training will not change throughout the duration of the experiment. A particular distance and the level of intensity will be monitored by researchers using sports application Strava. After the second measurement, there will be a 4-week adaptation phase for training in minimalist shoes. This kind of shoes is characterized by thin, flexible soles that are contoured to the shape of the human foot, including visible individual sections for the toes. The adaptation phase will include progression by increasing time of wearing the minimalist shoes. The shoes will be used every day, starting with 5 minutes per day and ending with 1 hour.
After the end of the stage, there will be a third measurement, after which runners will train in the minimalist shoes for 8 weeks. In that phase, the runners will start with 10 minutes of running in the minimalist shoes in the first week, increasing the running time by 5 minutes each week.
Intervention code [1] 320082 0
Treatment: Other
Comparator / control treatment
In the control group measurements of selected parameters in group 1 will be carried out three times: at the beginning of the project, after 8 weeks and after 16 weeks. At this time (over the 16 weeks), participants will perform running training, with frequency of 3-5 x 1 hour sessions per week. Running training will not change throughout the duration of the experiment. A particular distance and the level of intensity will be monitored by researchers using sports application Strava. For the first 8 weeks, participants of the research will continue their current running training, which will be monitored by researchers and will not change throughout the duration of the experiment. After 8 weeks the second measurement will be performed. After the second measurement the short foot muscles exercises program will be included. This phase will last 8 weeks. The study protocol will include the progression of exercises by increasing the load and level of difficulty every two weeks (for example changing position from double-leg standing to one-leg standing, from seated, standing, to half-squat position). The following tools will be used: a tennis ball, stability disc, and a band loop. In each exercise, participants will pay attention to the proper load on three support points: the heel and the heads of the 1 st and the 5 th metatarsals. The exercises will be performed barefoot. The complete exercise protocol will last approximately 30 minutes. It will be performed every day. Once a week, the training will be supervised by a physical therapist, who will examine the correctness of exercises performance. Moreover, every day, the participants will receive a reminder about the requirement to perform the exercises, which they will confirm doing in the diary.
The basic exercise will be the Short Foot Exercise, which consists of two stages: the 1 st: shortening the foot in the anteroposterior direction by bringing the heads of metatarsal bones towards the heel without toe flexion. Then, balanced loading of the three support points of the foot was performed: the heel and the heads of the 1 st and the 5 th metatarsals, maintaining shortened position. The progressions will include performing this exercise in seated, standing, and half-squat positions.
Another exercise will be the Reverse Tandem Gait exercise which will be performed by walking backward in a straight line with the arms alongside the body and one foot directly behind the other.
The Vele’s Forward Lean will be based on the maximal forward lean from the standing position. The exercise will be performed with the feet shoulder-width apart, with arms alongside the body, keeping heels on the ground and the body in alignment. During this exercise, the short foot position will be maintained with the proper loading of the foot support points. Moreover, the following tools will be used: a tennis ball and stability disc.
Control group
Active

Outcomes
Primary outcome [1] 326951 0
Evaluation of the bioelectrical activity of muscles at rest and during dynamic examination within the gastrocnemius and hamstring muscles using surface electromyography.
Timepoint [1] 326951 0
In the experimental group: Baseline, after 8 weeks without any interevention, after 4 weeks of adaptation to minimalistic shoes, after 8 weeks of running in minimalistic shoes.
In the control group: Baseline, after 8 weeks without any intervention, after 8 weeks of short foot muscles exercises.
Primary outcome [2] 326952 0
The running velocity corresponding to lactate threshold (VLT) using the progressive running test
Timepoint [2] 326952 0
In the experimental group: Baseline, after 8 weeks without any interevention, after 4 weeks of adaptation to minimalistic shoes, after 8 weeks of running in minimalistic shoes.
In the control group: Baseline, after 8 weeks without any intervention, after 8 weeks of short foot muscles exercises.
Primary outcome [3] 326953 0
The isokinetic assessment of muscle strength, work and power of the flexors and extensors of the ankle and knee joints. This is a composite primary outcome measured using isokinetic dynamometer.
Timepoint [3] 326953 0
In the experimental group: Baseline, after 8 weeks without any interevention, after 4 weeks of adaptation to minimalistic shoes, after 8 weeks of running in minimalistic shoes.
In the control group: Baseline, after 8 weeks without any intervention, after 8 weeks of short foot muscles exercises.
Secondary outcome [1] 393234 0
The functional assessment by the Functional Movement Screen Test.
Timepoint [1] 393234 0
In the experimental group: Baseline, after 8 weeks without any interevention, after 4 weeks of adaptation to minimalistic shoes, after 8 weeks of running in minimalistic shoes.
In the control group: Baseline, after 8 weeks without any intervention, after 8 weeks of short foot muscles exercises.
Secondary outcome [2] 393235 0
Load distribution will be assessed by baropodometry platform during standing and walking.
Timepoint [2] 393235 0
In the experimental group: Baseline, after 8 weeks without any interevention, after 4 weeks of adaptation to minimalistic shoes, after 8 weeks of running in minimalistic shoes.
In the control group: Baseline, after 8 weeks without any intervention, after 8 weeks of short foot muscles exercises.
Secondary outcome [3] 419649 0
Foot placement will be assessed by The Foot Posture Index (FPI-6).
Timepoint [3] 419649 0
In the experimental group: Baseline, after 8 weeks without any interevention, after 4 weeks of adaptation to minimalistic shoes, after 8 weeks of running in minimalistic shoes. In the control group: Baseline, after 8 weeks without any intervention, after 8 weeks of short foot muscles exercises.

Eligibility
Key inclusion criteria
regularly performed running training at least 3 times a week and at least 20 km per week
Minimum age
20 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
previous history of acute injury in the six months prior to the enrollment on the study; deformations and defects in foot structure; using minimalist shoes or short foot muscles exercises before starting the project

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed using sequentially numbered opaque and sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by flipping a coin
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed using the STATISTICA 12.0 Pl software. The Shapiro–Wilk test will be conducted to assess data for normality. To determine the significance of differences analysis of variance will be performed. Post-hoc analysis will performed using the post-hoc test. Using the paired t-test for power analysis of exercise, it was determined that at least 30 subjects from each group were required to obtain a power of 0.8 at a two-sided level of 0.05 with the effect size of d = 0.8.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2021
Actual
1/11/2021
Date of last participant enrolment
Anticipated
7/11/2021
Actual
7/11/2021
Date of last data collection
Anticipated
20/03/2022
Actual
20/03/2022
Sample size
Target
60
Accrual to date
Final
58
Recruitment outside Australia
Country [1] 23561 0
Poland
State/province [1] 23561 0
Kraków

Funding & Sponsors
Funding source category [1] 308175 0
Self funded/Unfunded
Name [1] 308175 0
None
Country [1] 308175 0
Primary sponsor type
Individual
Name
PhD Iwona Sulowska-Daszyk
Address
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 308952 0
None
Name [1] 308952 0
Address [1] 308952 0
Country [1] 308952 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308160 0
The Ethical Committee of Regional Medical Chamber in Krakow
Ethics committee address [1] 308160 0
Ethics committee country [1] 308160 0
Poland
Date submitted for ethics approval [1] 308160 0
Approval date [1] 308160 0
19/03/2021
Ethics approval number [1] 308160 0
70/KBL/OIL/2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109746 0
Dr Iwona Sulowska-Daszyk
Address 109746 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 109746 0
Poland
Phone 109746 0
+48126831134
Fax 109746 0
Email 109746 0
[email protected]
Contact person for public queries
Name 109747 0
Iwona Sulowska-Daszyk
Address 109747 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 109747 0
Poland
Phone 109747 0
+48126831134
Fax 109747 0
Email 109747 0
[email protected]
Contact person for scientific queries
Name 109748 0
Iwona Sulowska-Daszyk
Address 109748 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 109748 0
Poland
Phone 109748 0
+48126831134
Fax 109748 0
Email 109748 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Results will be analysed at the experimental and control groups data level, and any results from this trial that are published in scientific journals will publish group data only.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.