NCT03529734

Brief Summary

In this research project, effects of two sports specific types of fatiguing protocols on trunk muscles and specific trunk stability indicators will be studied. In general, sports activities involving gross motor activities activate higher percentage of muscle mass. In addition, such activities usually demand increased ventilation and more demanding inter-muscular activation. Such an example is running, with medium intensity until exhaustion or with the goal to cover the longest distance possible in a given time. On the contrary, sports practice often incorporates local strengthening exercises into a workout, especially for the trunk muscles. These, if performed correctly, cause localized muscle fatigue and can affect their function. Understanding the effects of these activities is of importance for coaches as well as for health care providers, as other types of training usually follow such activities that can more easily lead to trunk or spinal overload. We expect that localized muscle strengthening protocol until exhaustion will have more detrimental effects on trunk stability indicators as fatiguing with exhaustive running. In these study 100 subjects will be studied, divided into two groups. First group will perform an exhaustive running protocol and the second group a localized trunk muscle strengthening protocol until exhaustion. The effect of intervention will be studied by observing the changes in trunk muscle reflex responses following sudden arm loading and changes in anticipated trunk muscle activation during a quick arm raising task. Activation latencies and electromyographic (EMG) amplitude, and center of foot pressure excursion will be used to quantify trunk stability. In addition, center of pressure movement during a sitting balance task will be studied as to gather information of local trunk stabilization functions. Finally, changes in joint position sense will be assessed in order to account for the possible changes in kinesthesia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

February 12, 2018

Last Update Submit

May 7, 2018

Conditions

Keywords

Anticipatory postural adjustmentsTrunk muscles reflex responsesSitting balanceKinesthesia

Outcome Measures

Primary Outcomes (8)

  • Amplitude of EMG response to sudden arm raising.

    EMG responses of the Erector spinae, Multifidus, Obliquus internus, Obliquus externus and Rectus abdominis will be studied.

    Change from baseline to after intervention (12 minutes).

  • Latency of EMG response to sudden arm raising.

    EMG responses of the Erector spinae, Multifidus, Obliquus internus, Obliquus externus and Rectus abdominis will be studied.

    Change from baseline to after intervention (12 minutes).

  • Amplitude of EMG response to sudden arm loading.

    EMG responses of the Erector spinae, Multifidus, Obliquus internus, Obliquus externus and Rectus abdominis will be studied.

    Change from baseline to after intervention (12 minutes).

  • Latency of EMG response to sudden arm loading.

    EMG responses of the Erector spinae, Multifidus, Obliquus internus, Obliquus externus and Rectus abdominis will be studied.

    Change from baseline to after intervention (12 minutes).

  • Average Center of pressure velocity during sitting balance task.

    Subjects will sit on an wobble board, that will be positioned on a force plate. The legs will be positioned on a specially designed rests mounted to the wobble board. Different parameters will be used to analyze the center of pressure movement (CoP), such as Average velocity of the CoP movement in both directions, Average amplitude and maximal amplitude in both directions and average frequency of CoP movement in both directions.

    Change from baseline to after intervention (12 minutes).

  • Average Center of pressure amplitude during sitting balance task.

    Subjects will sit on an wobble board, that will be positioned on a force plate. The legs will be positioned on a specially designed rests mounted to the wobble board. Different parameters will be used to analyze the center of pressure movement (CoP), such as Average velocity of the CoP movement in both directions, Average amplitude and maximal amplitude in both directions and average frequency of CoP movement in both directions.

    Change from baseline to after intervention (12 minutes).

  • Average Center of Pressure frequency during sitting balance task.

    Subjects will sit on an wobble board, that will be positioned on a force plate. The legs will be positioned on a specially designed rests mounted to the wobble board. Different parameters will be used to analyze the center of pressure movement (CoP), such as Average velocity of the CoP movement in both directions, Average amplitude and maximal amplitude in both directions and average frequency of CoP movement in both directions.

    Change from baseline to after intervention (12 minutes).

  • Trunk Reposition Error

    Subjects will be standing upright with their eyes cowered. They will have to move into trunk flexion and hold a certain position determined by the investigator. In the next repetition the subject will have to repeat the same forward lean and hold the previously determined position. The parameter observed will be the difference between the angles.

    Change from baseline to after intervention (12 minutes).

Secondary Outcomes (6)

  • Maximal trunk extension voluntary torque

    Change from baseline to after intervention (12 minutes).

  • Maximal trunk flexion voluntary torque

    Change from baseline to after intervention (12 minutes).

  • Center of pressure velocity during sudden arm raising.

    Change from baseline to after intervention (12 minutes).

  • Center of pressure amplitude during sudden arm raising.

    Change from baseline to after intervention (12 minutes).

  • Center of pressure velocity during sudden arm loading.

    Change from baseline to after intervention (12 minutes).

  • +1 more secondary outcomes

Study Arms (2)

12 min running group

EXPERIMENTAL

This group will perform a 12 min high intensity running with the goal to cover maximal possible distance.

Other: 12 min running

Local strengthening exercise group

EXPERIMENTAL

This group will perform local strengthening exercises (curl-ups, left side trunk flexion, trunk extension, right side trunk flexion). Each participant will have to perform three sets of each exercise with the maximal possible number of repetitions with a slow tempo (1s concentric phase and 2 s eccentric phase). Between sets, minimal rest (15 s) will be administered.

Other: Local strengthening exercises

Interventions

This was already explained in the description of arm

12 min running group

This was already explained in the description of arm

Local strengthening exercise group

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals
  • Age between 20 and 30 years

You may not qualify if:

  • Chronic illness of the loco-motor system
  • Acute injury of the loco-motor system in the last 1.5 years
  • Neurological disease or injury
  • Balance related pathology
  • Vision pathology or untreated vision deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Primorska

Izola, 6310, Slovenia

RECRUITING

MeSH Terms

Interventions

Running

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr. Sc.

Study Record Dates

First Submitted

February 12, 2018

First Posted

May 18, 2018

Study Start

June 1, 2018

Primary Completion

September 30, 2018

Study Completion

October 30, 2018

Last Updated

May 18, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations