- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03863340
Short Interventions to Prevent Trapezius Muscle Fatigue in Computer Work
Trapezius Muscle Fatigue of Long Duration: a Likely Neuromuscular Control Issue
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
30 healthy adults without chronic neck pain participated in a laboratory study designed to simulate two full workdays of computer work. Within each session, participants performed five 50-min working activities separated by 10-min breaks: i) Use a computer keyboard to type a text presented on the left side of the screen; ii) do the typing task with the desk height set10 cm above elbow height; iii) play the computer game Spider Solitaire implemented in Windows 10; iv) Stroop test (This test consists of reading the name of a color whose text is in a color different from the name. The color name was then selected from a multiple-choice panel displaying color names; v) the same online puzzle game was presented to all participants. Assembling the puzzle was performed by drag and drop actions. The work periods were not disrupted (on the "control day") whereas two short interruptions of 5-min were introduced at 1/3 and 2/3 of each working period on the "intervention day". During these interruptions, participants were asked to perform "muscle disrupting/relaxing" activities. For each experimental session a 30-min lunch break took place between the third and the fourth work periods. The specific sequence of work activity type and disrupting/relaxing activities was randomized across participants; however, for each participant the order of work activities remained the same for the two experimental sessions (control and intervention days). The order of control and intervention days was also randomized between participants.
A set of six measures were performed at specific time intervals during each experiment: before the first work activity, before and after lunch, immediately and 1 hour after the fifth (last) work activity: i) upper trapezius activation, assessed through the temporal EMG profile recorded by a single bipolar signal; and ii) through the spatio-temporal distribution of EMG activity detected by a 2D array of electrodes (64 channels); iii) muscle fatigue, quantified by changes in electrically induced muscle twitch force signals, iv) isometric performance, v) dynamic performance; iii) cognitive and physical load and stress level. In addition, personality traits (anxiety level), perceived workload and musculoskeletal symptoms were evaluated as covariates.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- healthy experienced computer workers
Exclusion Criteria:
- chronic pain (more than 30 days within the last 12 months according to the Nordic Questionnaire (Kuorinka et al 1987);
- pathologies of the neck,
- prior and actual shoulder or neck pain caused by an accident,
- skin disease in the neck or shoulder area,
- BMI > 30,
- sleep disorders (e.g. apnea, restless legs syndrome),
- use of medications such as psychotropic drugs, muscle relaxants or analgesics within the last 3 days prior to the experiment,
- pregnancy.
- any shoulder/neck pain on the day before the experiment.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Intervenční model: Sekvenční přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: short interruptions of work tasks
randomly start with or without short interruptions on the first experimental day and without or with them on the second experimental day
|
During each activity two interruptions/breaks were selected randomly from a set of ten predetermined actions: Active break types:
Passive break types:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
EMG profile recorded by a single bipolar electrode: Rest-time
Časové okno: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
Rest-time (percentage of time below 5% of the standard activity level).
The percentage of registration time without any rest time is called sustained low level muscle activity.
|
Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
|
Spatio-temporal distribution of EMG activity: Area of muscle activity
Časové okno: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
The spatio-temporal distribution of EMG activity is detected by a 2D array of electrodes (64 channels) and the following outcomes are determined: Area of muscle active region (n. of channels) |
Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
|
Muscle fatigue: Change of muscle twitch
Časové okno: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
3-D muscle twitch acceleration pattern measured at the acromion
|
Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
|
Muscle fatigue: Change of dynamic force control accuracy
Časové okno: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
Force control accuracy (mean squared error between the produced force (N) and the target force (N)) in an isometric dynamic tracking task
|
Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
EMG profile recorded by a single bipolar electrode: Static activity
Časové okno: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
p10 (level of the 10th percentile of the trapezius muscle activity) as an indicator of static activity primarily associated with continuous activity of the same pool of motor units.
|
Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
|
Spatio-temporal distribution of EMG activity: Magnitude of activity
Časové okno: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
The spatio-temporal distribution of EMG activity is detected by a 2D array of electrodes (64 channels) and the following outcomes are determined: Magnitude of activity of muscle active regions (RMS sEMG). |
Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
|
Spatio-temporal distribution of EMG activity: Number of active epochs
Časové okno: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
The spatio-temporal distribution of EMG activity is detected by a 2D array of electrodes (64 channels) and the following outcomes are determined: Number of active epochs
|
Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
|
Muscle fatigue: Change of static force control
Časové okno: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
Force control accuracy (mean squared error between the produced force (N) and the target force (N)) in isometric isotonic low level contraction
|
Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
|
Muscle fatigue: Change of force control in ramp contraction
Časové okno: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
Force control accuracy (mean squared error between the produced force (N) and the target force (N)) in isometric ramp contraction.
|
Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Localized musculoskeletal discomfort
Časové okno: At the start, and 70min, 130min, 190min, 310min, 370 min after the beginning of the simulated working activity of both the control and intervention day
|
head-neck-shoulders-lower back-elbows-wrists-hip-upper legs-knees-ankles-feet-discomfort rated on 10 cm visual analog scales (adapted from Nordic questionnaire (Kuorinka et al 1987)
|
At the start, and 70min, 130min, 190min, 310min, 370 min after the beginning of the simulated working activity of both the control and intervention day
|
|
Visual and general fatigue
Časové okno: At the start, and 70min, 130min, 190min, 310min, 370 min after the beginning of the simulated working activity of both the control and intervention day
|
10 cm visual analog scales
|
At the start, and 70min, 130min, 190min, 310min, 370 min after the beginning of the simulated working activity of both the control and intervention day
|
|
Effort
Časové okno: At the start, and 70min, 130min, 190min, 310min, 370 min after the beginning of the simulated working activity of both the control and intervention day
|
6-20 Borg scale (6= no effort, 20=maximal possible effort)
|
At the start, and 70min, 130min, 190min, 310min, 370 min after the beginning of the simulated working activity of both the control and intervention day
|
|
EMG profile recorded by a single bipolar electrode: Dynamic activity
Časové okno: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
p90 (level of the 90th percentile of the trapezius muscle activity) as an indicator of dynamic activity which may promote variability in the recruitment of motor units
|
Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
|
Spatio-temporal distribution of EMG activity: Centroid of active regions
Časové okno: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
The spatio-temporal distribution of EMG activity is detected by a 2D array of electrodes (64 channels) and the following outcomes are determined: Centroid of active regions
|
Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Thomas Läubli, MD, Federal Institute of Technology Zurich
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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Klinické studie na interruptions of work tasks
-
Université du Québec a MontréalFonds de recherche du Québec - Société et cultureAktivní, ne nábor