NCT03863340

Brief Summary

This study is expected to demonstrate that during experimental days of seated computer work sustained and focalized low-level muscle activity contributes to the development of long-lasting fatigue effects (and thus possible disorder). On days with and without frequent interruptions, signs of fatigue and the activity pattern of the trapeze muscle are registered and compared using electromyographic registrations of the trapezius muscle.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2016

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
Last Updated

March 5, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

December 14, 2018

Last Update Submit

March 1, 2019

Conditions

Keywords

muscle fatiguework-related disorderstrapezius myalgiasustained working taskhigh-density EMG

Outcome Measures

Primary Outcomes (4)

  • EMG profile recorded by a single bipolar electrode: Rest-time

    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

    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

    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

    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

Secondary Outcomes (5)

  • EMG profile recorded by a single bipolar electrode: Static 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: Magnitude of 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: 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

    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

    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

Other Outcomes (5)

  • Localized musculoskeletal discomfort

    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

    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

    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

  • +2 more other outcomes

Study Arms (1)

short interruptions of work tasks

EXPERIMENTAL

randomly start with or without short interruptions on the first experimental day and without or with them on the second experimental day

Behavioral: interruptions of work tasks

Interventions

During each activity two interruptions/breaks were selected randomly from a set of ten predetermined actions: Active break types: * Move shoulder and upper back * Swing arms near the body * Three slow but forceful elevations of the shoulders, a relaxation exercise based on the principles developed by Jacobson * Stand up and stretch * Slowly turn head in all possible directions. Passive break types: * Tell a couple of jokes * Stand up and have a drink * Relaxing the trapezius * Questions on actual posture and feelings of comfort / discomfort. * A short rest on the couch

short interruptions of work tasks

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy experienced computer workers

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Thomas Läubli, MD

    Federal Institute of Technology Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Masking Details
Participants were informed that the study investigates neuro-motor mechanisms but not about the more specific research questions.
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Randomized controlled laboratory experiment. 30 subjects are randomly assigned to two full day experiments either starting with the conditions including additional short interventions or without them.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2018

First Posted

March 5, 2019

Study Start

March 14, 2016

Primary Completion

September 5, 2016

Study Completion

September 5, 2016

Last Updated

March 5, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share