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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

injury

tissue overload

Condition category

Condition code

Musculoskeletal

Normal musculoskeletal and cartilage development and function

Physical Medicine / Rehabilitation

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]

Treatment: Other

Intervention code [2]

Prevention

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Baseline, after 6 weeks of short foot muscles exercise, after 6 weeks of functional training

Primary outcome [2]

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]

Baseline, after 6 weeks of short foot muscles exercise, after 6 weeks of functional training

Secondary outcome [1]

Quality of fundamental movement patterns

Will be assessed by Functional Movement Screen test.

Timepoint [1]

Baseline, after 6 weeks of short foot muscles exrcise, after 6 weeks of functional training

Secondary outcome [2]

Foot posture

Will be assessed by The Foot Posture Index (FPI-6)

Timepoint [2]

Baseline, after 6 weeks of short foot muscles exrcise, after 6 weeks of functional training

Secondary outcome [3]

Lower limbs power
Will be assessed by plyometrics platform during jumps

Timepoint [3]

Baseline, after 6 weeks of short foot muscles exrcise, after 6 weeks of functional training

Secondary outcome [4]

Load distribution

Will be assessed by baropodometry platform during standing and walking

Timepoint [4]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Ethical Committee of Regional Medical Chamber in Krakow

Ethics committee address [1]

 ul. Krupnicza 11a, 31-123 Krakow, Poland

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

Approval date [1]

15/04/2015

Ethics approval number [1]

40/KBL/OIL/2015

Summary

Brief summary

Running is one of the most common forms of movement activities but, unfortunately, dangers of injuries or strains are high on both professional and amateur level. When an injury takes place it triggers sequence of changes in movement apparatus causing consequential dysfunctions. Risk factors of foot injuries constitute a whole separate group especially in runners. 
Functional training is understood as a specific set of exercises aimed to establish essential movement patterns vital for normal development of motor abilities in athletes. It ensures separate elements of biokinematic chain are combined into an optimal movement pattern. Functional training is employed to improve physical fitness and results in sports, and to decrease injury risks.
Main assumption of “joint-by-joint” therapy conception is a holistic approach to an athlete or a patient. Insufficient stability in a certain body area (e.g. lumbar spine) could be caused by insufficient mobility in the area nearby (e.g. limited hip-joint extension). According to “joint-by-joint” conception therapy should begin first with exercises improving mobility, from the ankle up, segment by segment, then continue with improving stability. 
Exercises which activate inner foot muscles on the plantar side aim to restore strength and normal muscle tension as well as strengthen medial longitudinal arch, what, in its turn, increase stability in the ankle. Those exercises are employed both in sports and rehabilitation. They are advised in cases of ankle injuries, pes planus, claw and hammer toes as well as an element of sensomotor training. But have not found any reports on employment of those exercises in runners.
Functional examination, by means of detection of all limitations and asymmetries, allows to employ individually customized trainings, which could stimulate restoration of correct movement patterns and decrease injury risks in athletes and patients.
Aims
The aim of the presented research is to define influence of exercising short plantar foot muscles on foot placement and functional movement patterns in runners. Above that we would like to assess efficiency of functional training based on “joint-by-joint” therapy conception, customized to compensate individual limitations and dysfunctions in runners.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Anna Mika

Address

University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow

Country

Poland

Phone

(4812)6831134

Fax

anna.mika@awf.krakow.pl

Contact person for public queries

Name

Anna Mika

Address

University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow

Country

Poland

Phone

(4812)6831134

Fax

anna.mika@awf.krakow.pl

Contact person for scientific queries

Name

Anna Mika

Address

University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow

Country

Poland

Phone

(4814)6831134

Fax

anna.mika@awf.krakow.pl

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	The 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.	2019	https://dx.doi.org/10.1155/2019/6947273

N.B. These documents automatically identified may not have been verified by the study sponsor.

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