Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001200572
Ethics application status
Approved
Date submitted
16/09/2015
Date registered
4/11/2015
Date last updated
22/06/2021
Date data sharing statement initially provided
22/06/2021
Date results provided
22/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The evaluation the efficacy of functional training based on „joint-by-joint” approach in long distance runners.
Scientific title
The evaluation the efficacy of functional training based on „joint-by-joint” approach in long distance runners.
Secondary ID [1] 287489 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
injury 296231 0
tissue overload 296233 0
Condition category
Condition code
Musculoskeletal 296503 296503 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 296504 296504 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Functional training employed by us consists of two stages.
The first one lasts 6 weeks and is devoted to activation of inner foot muscles on the plantar side. The exercises will be performed barefoot with the proper loading of three support points of the feet (the first and the fifth metatarsal heads and the heel). Three kinde of exercise will be applied “Vele’s Forward Lean” (maximal forward lean from a standing position), “Reverse Tandem Gait” (walking backwards) and “Short Foot Exercise” (shortening the foot in the anterior-posterior direction and attempting to bring the head of the metatarsals towards the heel without toe flexion).
The second stage lasts also 6 weeks and is devoted to functional training, which comprises exercises individually customized for each runner aiming to correct their particular dysfunctions. This functional training aims to improve mobility and stability.
The exercise wil be chosen from Functional Movement Screen Corrective Exercise Manual.
Each subject will be examined three times: before the first stage, after the first stage and after the second stage. Trainings will be done every day and each session will last about one hour. Six of the seven sessions per week will be done under no supervision at home. Each subject will be asked to fill the training diary after training session. One training a week will be done under the therapist control.
Intervention code [1] 292872 0
Treatment: Other
Intervention code [2] 293113 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296131 0
Influence of functional training and exercising short plantar foot muscles on foot placement.
Foot placement will be assessed by The Foot Posture Index (FPI-6)
Timepoint [1] 296131 0
Baseline, after 6 weeks of short foot muscles exercise, after 6 weeks of functional training
Primary outcome [2] 296425 0
Influence of functional training and exercising short plantar foot muscles functional movement patterns

Functional movement patterns will be assessed by Functional Movement Screen test.
Timepoint [2] 296425 0
Baseline, after 6 weeks of short foot muscles exercise, after 6 weeks of functional training
Secondary outcome [1] 317582 0
Quality of fundamental movement patterns

Will be assessed by Functional Movement Screen test.
Timepoint [1] 317582 0
Baseline, after 6 weeks of short foot muscles exrcise, after 6 weeks of functional training
Secondary outcome [2] 318412 0
Foot posture

Will be assessed by The Foot Posture Index (FPI-6)
Timepoint [2] 318412 0
Baseline, after 6 weeks of short foot muscles exrcise, after 6 weeks of functional training
Secondary outcome [3] 318413 0
Lower limbs power
Will be assessed by plyometrics platform during jumps
Timepoint [3] 318413 0
Baseline, after 6 weeks of short foot muscles exrcise, after 6 weeks of functional training
Secondary outcome [4] 318414 0
Load distribution

Will be assessed by baropodometry platform during standing and walking
Timepoint [4] 318414 0
Baseline, after 6 weeks of short foot muscles exrcise, after 6 weeks of functional training

Eligibility
Key inclusion criteria
long distance runners who run regularly 3-7 times a week with a total distance of 30-100 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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/04/2015
Date of last participant enrolment
Anticipated
Actual
30/11/2017
Date of last data collection
Anticipated
Actual
28/02/2018
Sample size
Target
60
Accrual to date
Final
75
Recruitment outside Australia
Country [1] 7172 0
Poland
State/province [1] 7172 0

Funding & Sponsors
Funding source category [1] 292063 0
Self funded/Unfunded
Name [1] 292063 0
Country [1] 292063 0
Primary sponsor type
Individual
Name
prof Anna Mika
Address
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 290738 0
None
Name [1] 290738 0
Address [1] 290738 0
Country [1] 290738 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293547 0
The Ethical Committee of Regional Medical Chamber in Krakow
Ethics committee address [1] 293547 0
Ethics committee country [1] 293547 0
Poland
Date submitted for ethics approval [1] 293547 0
Approval date [1] 293547 0
15/04/2015
Ethics approval number [1] 293547 0
40/KBL/OIL/2015

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

Contacts
Principal investigator
Name 60418 0
A/Prof Anna Mika
Address 60418 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 60418 0
Poland
Phone 60418 0
(4812)6831134
Fax 60418 0
Email 60418 0
[email protected]
Contact person for public queries
Name 60419 0
Anna Mika
Address 60419 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 60419 0
Poland
Phone 60419 0
(4812)6831134
Fax 60419 0
Email 60419 0
[email protected]
Contact person for scientific queries
Name 60420 0
Anna Mika
Address 60420 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 60420 0
Poland
Phone 60420 0
(4814)6831134
Fax 60420 0
Email 60420 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


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
SourceTitleYear of PublicationDOI
EmbaseThe Influence of Plantar Short Foot Muscle Exercises on the Lower Extremity Muscle Strength and Power in Proximal Segments of the Kinematic Chain in Long-Distance Runners.2019https://dx.doi.org/10.1155/2019/6947273
N.B. These documents automatically identified may not have been verified by the study sponsor.