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Changes in Trunk Stability Indicators Following Two Types of Exhausting Physical Activities (TNC-FAT)

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ClinicalTrials.gov Identifier: NCT03529734
Recruitment Status : Unknown
Verified May 2018 by Nejc Sarabon, University of Primorska.
Recruitment status was:  Recruiting
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
S2P, Science to Practice, Ltd.
Motus Melior
Information provided by (Responsible Party):
Nejc Sarabon, University of Primorska

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.


Condition or disease Intervention/treatment Phase
Spine Stiffness Spine Stability Other: 12 min running Other: Local strengthening exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Neuro-Muscular Trunk Stabilization Functions and Development of Exercise Programs for Lower Back Pain Prevention
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 12 min running group
This group will perform a 12 min high intensity running with the goal to cover maximal possible distance.
Other: 12 min running
This was already explained in the description of arm

Experimental: Local strengthening exercise group
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
This was already explained in the description of arm




Primary Outcome Measures :
  1. Amplitude of EMG response to sudden arm raising. [ Time Frame: Change from baseline to after intervention (12 minutes). ]
    EMG responses of the Erector spinae, Multifidus, Obliquus internus, Obliquus externus and Rectus abdominis will be studied.

  2. Latency of EMG response to sudden arm raising. [ Time Frame: Change from baseline to after intervention (12 minutes). ]
    EMG responses of the Erector spinae, Multifidus, Obliquus internus, Obliquus externus and Rectus abdominis will be studied.

  3. Amplitude of EMG response to sudden arm loading. [ Time Frame: Change from baseline to after intervention (12 minutes). ]
    EMG responses of the Erector spinae, Multifidus, Obliquus internus, Obliquus externus and Rectus abdominis will be studied.

  4. Latency of EMG response to sudden arm loading. [ Time Frame: Change from baseline to after intervention (12 minutes). ]
    EMG responses of the Erector spinae, Multifidus, Obliquus internus, Obliquus externus and Rectus abdominis will be studied.

  5. Average Center of pressure velocity during sitting balance task. [ Time Frame: Change from baseline to after intervention (12 minutes). ]
    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.

  6. Average Center of pressure amplitude during sitting balance task. [ Time Frame: Change from baseline to after intervention (12 minutes). ]
    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.

  7. Average Center of Pressure frequency during sitting balance task. [ Time Frame: Change from baseline to after intervention (12 minutes). ]
    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.

  8. Trunk Reposition Error [ Time Frame: Change from baseline to after intervention (12 minutes). ]
    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.


Secondary Outcome Measures :
  1. Maximal trunk extension voluntary torque [ Time Frame: Change from baseline to after intervention (12 minutes). ]
    Subjects will be standing next to the custom designed dynamometer, measuring force in a neutral upright stance. During each repetition, an maximal force average over 1s interval will be calculated and used for further analysis.

  2. Maximal trunk flexion voluntary torque [ Time Frame: Change from baseline to after intervention (12 minutes). ]
    Subjects will be standing next to the custom designed dynamometer, measuring force in a neutral upright stance. During each repetition, an maximal force average over 1s interval will be calculated and used for further analysis.

  3. Center of pressure velocity during sudden arm raising. [ Time Frame: Change from baseline to after intervention (12 minutes). ]
    During quick hand rising task, subjects will be standing on a force plate. Amplitude of the Center of pressure movement will be analyzed 150 ms before and 150 ms after EMG onset.

  4. Center of pressure amplitude during sudden arm raising. [ Time Frame: Change from baseline to after intervention (12 minutes). ]
    During quick hand rising task, subjects will be standing on a force plate. Amplitude of the Center of pressure movement will be analyzed 150 ms before and 150 ms after EMG onset.

  5. Center of pressure velocity during sudden arm loading. [ Time Frame: Change from baseline to after intervention (12 minutes). ]
    During sudden hand loading task subjects will be standing on a force plate. Center of pressure movement will be analyzed 250 ms after loading the hands.

  6. Center of pressure amplitude during sudden arm loading. [ Time Frame: Change from baseline to after intervention (12 minutes). ]
    During sudden hand loading task subjects will be standing on a force plate. Center of pressure movement will be analyzed 250 ms after loading the hands.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy individuals
  • Age between 20 and 30 years

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529734


Contacts
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Contact: Nejc Šarabon, PhD +386 5 662 64 66 nejc.sarabon@fvz.upr.si

Locations
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Slovenia
University of Primorska Recruiting
Izola, Slovenia, 6310
Contact: assoc. prof. Nejc Šarabon    0036840429505    nejc.sarabon@upr.si   
Sponsors and Collaborators
University of Primorska
S2P, Science to Practice, Ltd.
Motus Melior
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Responsible Party: Nejc Sarabon, Assoc. Prof. Dr. Sc., University of Primorska
ClinicalTrials.gov Identifier: NCT03529734    
Other Study ID Numbers: UP-FVZ-Fatigue&TrunkStability
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nejc Sarabon, University of Primorska:
Anticipatory postural adjustments
Trunk muscles reflex responses
Sitting balance
Kinesthesia