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Spine StiffnessTNC-FATNCT03529734

Changes in Trunk Stability Indicators Following Two Types of Exhausting Physical Activities

A study testing 12 min running and Local strengthening exercises in people with Spine Stiffness and Spine Stability, run by University of Primorska at 1 site in Slovenia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Spine Stiffness, Spine Stability
What is being tested?
12 min running and Local strengthening exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteSlovenia
Study dates
1 Jun 2018to 30 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy individuals
  • Age between 20 and 30 years

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Nejc Šarabon, PhD contact

+386 5 662 64 66

nejc.sarabon@fvz.upr.si

Slovenia1 site, 1 recruiting
  • University of Primorska

    Izola, 6310

    assoc. prof. Nejc Šarabon, 0036840429505, nejc.sarabon@upr.si

    Recruiting

Other trials in Slovenia

About this study

Official title: Evaluation of Neuro-Muscular Trunk Stabilization Functions and Development of Exercise Programs for Lower Back Pain Prevention

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.

Read the detailed description

It has been shown, that fatiguing a muscles in a kinetic chain leads to changes in activities of other non-fatigued muscles during postural tasks. This indicates that central changes take place to adapt the muscle responses according to the new state of the kinetic chain. However, these studies have mainly been focused on studying the effects of localized isometrically induced muscular fatigue that is less relevant to the sport community. In sports training, trunk muscle fatigue is often induced by performing dynamic strength training during a workout session, followed by other training interventions that pose high demands on trunk stability. On the other hand, more complex and gross motor tasks are used such as running, that also have the potential to influence trunk stability. Their effect on trunk stability comes from changes in muscle function as well as form increased ventilation. In both cases, trunk stability can be affected, leading to increased risk of injury. Especially the localized fatigue of the trunk muscles can have a direct effect on trunk stabilizing activities. One might speculate, that the intramuscular coordination can change as to compensate for the decreased ability of the trunk muscles to produce trunk and spinal stabilization impulses. After exhaustive running, especially trunk extensors might be affected, because of the increased trunk forward lean. In addition, trunk muscles are important contributors to increased ventilation in such tasks. As opposed to isolated fatiguing, running might have more complex effects on the trunk stabilization.

It is of most relevance for sports trainers and health care community dealing with athletes to be familiar with the effects of exhaustive running and localized trunk muscle fatigue on trunk and spinal stability in order to be better suited in preventing low back pain. This understanding will enable preparation of more suited training plans, periodization and individualization approaches.

This study will recruit volunteers form local university. Each participant will receive his own identification code that will be known only to the principal investigator. In order to account for the possible bias of the investigators, these will not be allowed to participate in assessing subject, which they are familiar with. Six investigators will participate, all trained in performing the measurement and fatiguing protocols.

All participants will be familiarized with the measurement tasks to overcome possible misunderstandings during the study and to ensure most fluent execution of the measurement protocol. The familiarization will account for as much time as needed for the participants to become proficient in each assessment task. Each participant will sigh an informed consent form that will be prepared in accordance with declaration of Helsinki.

Prior to starting the measurements, each subject will perform a worm-up. The measurement will follow in a predefined order, starting with the EMG electrode placement. First subjects will (ii) perform measurements of trunk muscles reflex responses during a sudden hand loading, followed by (iii) measurements of anticipatory postural adjustments during a quick arm rising test, (iv) body sway during a sitting balance tasks, (v) joint position test and (vi) measurements of maximal voluntary contraction for trunk extension and flexion in a neutral upright stance. Next, subjects will perform a fatiguing protocol. One group of subjects will perform a twelve-minute running test (Coopers test) with the goal to cower as much distance as possible. Subjects in the second group will perform dynamic strengthening exercises (curl-up, right lateral trunk flexion, trunk extension and left lateral trunk flexion), each session performed until exhaustion. All together subjects in a dynamic strengthening group will perform three sets with minimal rest in between. Immediately after finishing the fatiguing protocol, the above measurement protocol will be repeated in the same order.

The measurement data will be saved to a personal computers encoded with the subject's identification code. During data acquisition, processing, statistical analysis and data presentation only identification codes will be used. No individual data will be presented. All data will be gathered in a common data sheet for further statistical analysis.

Prior to performing the study, the sample size will be calculated based on the effect size of data gathered during a pilot study using 10 subjects. For main results, fallowing statistics will be calculated:

  • Descriptive statistics.
  • For parameters not normally distributed, appropriate corrections will be made.
  • Intra-group differences prior to fatiguing protocol will be identified using the T-test for independent samples.
  • For parameters, where no baseline differences between the two groups were observed, a Two-way repeated measures ANOVA model will be used to observe the possible changes after fatiguing protocols and possible interaction effects for the two groups. Observed differences will be additionally studied with post-hock tests.
  • In cases where the baseline status between the two groups will be different, ANCOVA model will be used.
  • Correlations between the parameters will be studied using Pearson correlation coefficient.
Being tested
12 min running, Local strengthening exercises
Keywords
Anticipatory postural adjustments, Trunk muscles reflex responses, Sitting balance, Kinesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 12 min runningOther

    This was already explained in the description of arm

  • Local strengthening exercisesOther

    This was already explained in the description of arm

Study groups in NCT03529734
Study groupRoleWhat they receive
12 min running groupExperimentalThis group will perform a 12 min high intensity running with the goal to cover maximal possible distance.
Receives: Other: 12 min running
Local strengthening exercise groupExperimentalThis 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.
Receives: Other: Local strengthening exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline to after intervention (12 minutes).

  2. 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.

    Measured: Change from baseline to after intervention (12 minutes).

  3. 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.

    Measured: Change from baseline to after intervention (12 minutes).

  4. 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.

    Measured: Change from baseline to after intervention (12 minutes).

  5. 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.

    Measured: Change from baseline to after intervention (12 minutes).

  6. 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.

    Measured: Change from baseline to after intervention (12 minutes).

  7. 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.

    Measured: Change from baseline to after intervention (12 minutes).

  8. 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.

    Measured: Change from baseline to after intervention (12 minutes).

Secondary outcomes (6)
  1. Maximal trunk extension voluntary torque

    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.

    Measured: Change from baseline to after intervention (12 minutes).

  2. Maximal trunk flexion voluntary torque

    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.

    Measured: Change from baseline to after intervention (12 minutes).

  3. Center of pressure velocity during sudden arm raising.

    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.

    Measured: Change from baseline to after intervention (12 minutes).

  4. Center of pressure amplitude during sudden arm raising.

    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.

    Measured: Change from baseline to after intervention (12 minutes).

  5. Center of pressure velocity during sudden arm loading.

    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.

    Measured: Change from baseline to after intervention (12 minutes).

  6. Center of pressure amplitude during sudden arm loading.

    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.

    Measured: Change from baseline to after intervention (12 minutes).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2018
  2. Study start1 Jun 2018 (estimated)
  3. Primary completion30 Sep 2018 (estimated)
  4. Study completion30 Oct 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03529734
Sponsor's protocol ID
UP-FVZ-Fatigue&TrunkStability
Acronym
TNC-FAT
Status last verified
May 2018
First submitted
12 Feb 2018
Last updated
18 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 12 min running and Local strengthening exercises in people with Spine Stiffness and Spine Stability, run by University of Primorska at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nejc Šarabon, PhD (+386 5 662 64 66, nejc.sarabon@fvz.upr.si), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amplitude of EMG response to sudden arm raising. (time frame: Change from baseline to after intervention (12 minutes).). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.

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