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TNC-FAT
Evaluation of Neuro-Muscular Trunk Stabilization Functions and Development of Exercise Programs for Lower Back Pain Prevention
Sponsor study identifier
interventional
110
1 country
1
Study Start
June 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 12, 2018
Actual (reported)May 18, 2018
Actual (reported)June 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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).
This group will perform a 12 min high intensity running with the goal to cover maximal possible distance.
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.
This was already explained in the description of arm
This was already explained in the description of arm
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Primorska
Izola, 6310, Slovenia
First Submitted
February 12, 2018
First Posted
May 18, 2018
Study Start
June 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2018
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).
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 18, 2018
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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