NCT02881801

Brief Summary

This study aims to describe the pattern of active and sedentary time in survivors of a critical illness, at three time points during their hospital admission (awakening in the ICU after ≥ 5 days of mechanical ventilation, discharge to ward and discharge from hospital). The specific research objectives are to

  1. 1.Determine the duration of active and sedentary parameters including time and bouts in 24 hour periods
  2. 2.Examine changes in the active and sedentary parameters including time and bouts between time points of awakening and both ICU and hospital discharge.
  3. 3.Conduct a preliminary examination of relationships between activity and sedentary behaviour metrics with measures of muscle strength, physical function and hospital length of stay.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

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 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

1.3 years

First QC Date

August 3, 2016

Last Update Submit

August 23, 2016

Conditions

Keywords

accelerometry

Outcome Measures

Primary Outcomes (12)

  • Physical activity time

    Total time in minutes over 24 hours periods spent: at light, moderate and vigorous activity thresholds, in body positions of standing, walking and upright. Minute data derived from 2 accelerometers worn concurrently on each measurement occasion (wrist worn geneactiv for activity thresholds and thigh worn activpal for body postures)

    Change between events (each event assessed over 24 hours): From closest to the date of awakening in ICU (after at least 5 days of mechanical ventilation, assessed up to 4 months) to closest to the date of ICU discharge (assessed up to 6 months)

  • Physical activity bouts

    Total number of bouts of physical activity over 24 hours periods spent: in light, moderate and vigorous activity thresholds, in body positions of standing, walking and upright. Data on number of bouts derived from 2 accelerometers worn concurrently on each measurement occasion (wrist worn geneactiv for activity thresholds and thigh worn activpal for body postures)

    Change between events (each event assessed over 24 hours): From closest to the date of awakening in ICU (after at least 5 days of mechanical ventilation, assessed up to 4 months) to closest to the date of ICU discharge (assessed up to 6 months)

  • Sedentary time

    Total time in minutes over 24 hours periods spent: at a sedentary activity threshold, and in body positions of sitting/lying. Minute data derived from 2 accelerometers worn concurrently on each measurement occasion (wrist worn geneactiv for activity thresholds and thigh worn activpal for body postures)

    Change between events (each event assessed over 24 hours): From closest to the date of awakening in ICU (after at least 5 days of mechanical ventilation, assessed up to 4 months) to closest to the date of ICU discharge (assessed up to 6 months)

  • Sedentary bouts

    Total number of bouts of sedentary time over 24 hours periods spent: at a sedentary activity threshold, and in body positions of sitting/lying. Data on number of bouts derived from 2 accelerometers worn concurrently on each measurement occasion (wrist worn geneactiv for activity thresholds and thigh worn activpal for body postures)

    Change between events (each event assessed over 24 hours): From closest to the date of awakening in ICU (after at least 5 days of mechanical ventilation, assessed up to 4 months) to closest to the date of ICU discharge (assessed up to 6 months)

  • Physical activity time

    Total time in minutes over 24 hours periods spent: at light, moderate and vigorous activity thresholds, in body positions of standing, walking and upright. Minute data derived from 2 accelerometers worn concurrently on each measurement occasion (wrist worn geneactiv for activity thresholds and thigh worn activpal for body postures)

    Change between events (each event assessed over 24 hours): From closest to the date of awakening in ICU (after at least 5 days of mechanical ventilation, assessed up to 4 months) to closest to the date of hospital discharge (assessed up to 12 months)

  • Physical activity bouts

    Total number of bouts of physical activity over 24 hours periods spent: in light, moderate and vigorous activity thresholds, in body positions of standing, walking and upright. Data on number of bouts derived from 2 accelerometers worn concurrently on each measurement occasion (wrist worn geneactiv for activity thresholds and thigh worn activpal for body postures)

    Change between events (each event assessed over 24 hours): From closest to the date of awakening in ICU (after at least 5 days of mechanical ventilation, assessed up to 4 months) to closest to the date of hospital discharge (assessed up to 12 months)

  • Sedentary time

    Total time in minutes over 24 hours periods spent: at a sedentary activity threshold, and in body positions of sitting/lying. Minute data derived from 2 accelerometers worn concurrently on each measurement occasion (wrist worn geneactiv for activity thresholds and thigh worn activpal for body postures)

    Change between events (each event assessed over 24 hours): From closest to the date of awakening in ICU (after at least 5 days of mechanical ventilation, assessed up to 4 months) to closest to the date of hospital discharge (assessed up to 12 months)

  • Sedentary bouts

    Total number of bouts of sedentary time over 24 hours periods spent: at a sedentary activity threshold, and in body positions of sitting/lying. Data on number of bouts derived from 2 accelerometers worn concurrently on each measurement occasion (wrist worn geneactiv for activity thresholds and thigh worn activpal for body postures)

    Change between events (each event assessed over 24 hours): From closest to the date of awakening in ICU (after at least 5 days of mechanical ventilation, assessed up to 4 months) to closest to the date of hospital discharge (assessed up to 12 months)

  • Physical activity time

    Total time in minutes over 24 hours periods spent: at light, moderate and vigorous activity thresholds, in body positions of standing, walking and upright. Minute data derived from 2 accelerometers worn concurrently on each measurement occasion (wrist worn geneactiv for activity thresholds and thigh worn activpal for body postures)

    Change between events (each event assessed over 24 hours): From closest to the date of ICU discharge (assessed up to 6 months) to closest to the date of hospital discharge (assessed up to 12 months)

  • Physical activity bouts

    Total number of bouts of physical activity over 24 hours periods spent: in light, moderate and vigorous activity thresholds, in body positions of standing, walking and upright. Data on number of bouts derived from 2 accelerometers worn concurrently on each measurement occasion (wrist worn geneactiv for activity thresholds and thigh worn activpal for body postures)

    Change between events (each event assessed over 24 hours): From closest to the date of ICU discharge (assessed up to 6 months) to closest to the date of hospital discharge (assessed up to 12 months)

  • Sedentary time

    Total time in minutes over 24 hours periods spent: at a sedentary activity threshold, and in body positions of sitting/lying. Minute data derived from 2 accelerometers worn concurrently on each measurement occasion (wrist worn geneactiv for activity thresholds and thigh worn activpal for body postures)

    Change between events (each event assessed over 24 hours): From closest to the date of ICU discharge (assessed up to 6 months) to closest to the date of hospital discharge (assessed up to 12 months)

  • Sedentary bouts

    Total number of bouts of sedentary time over 24 hours periods spent: at a sedentary activity threshold, and in body positions of sitting/lying. Data on number of bouts derived from 2 accelerometers worn concurrently on each measurement occasion (wrist worn geneactiv for activity thresholds and thigh worn activpal for body postures)

    Change between events (each event assessed over 24 hours): From closest to the date of ICU discharge (assessed up to 6 months) to closest to the date of hospital discharge (assessed up to 12 months)

Secondary Outcomes (12)

  • Peripheral muscle strength

    Change between events (each event assessed within 24 hours): From closest to the date of awakening in ICU (after at least 5 days of mechanical ventilation, assessed up to 4 months) to closest to the date of ICU discharge (assessed up to 6 months)

  • Peripheral muscle strength

    Change between events (each event assessed within 24 hours): From closest to the date of awakening in ICU (after at least 5 days of mechanical ventilation, assessed up to 4 months) to closest to the date of hospital discharge (assessed up to 12 months)

  • Peripheral muscle strength

    Change between events (each event assessed within 24 hours): From closest to the date of ICU discharge (assessed up to 6 months) to closest to the date of hospital discharge (assessed up to 12 months)

  • Hand grip strength

    Change between events (each event assessed within 24 hours): From closest to the date of awakening in ICU (after at least 5 days of mechanical ventilation, assessed up to 4 months) to closest to the date of ICU discharge (assessed up to 6 months)

  • Hand grip strength

    Change between events (each event assessed within 24 hours): From closest to the date of awakening in ICU (after at least 5 days of mechanical ventilation, assessed up to 4 months) to closest to the date of hospital discharge (assessed up to 12 months)

  • +7 more secondary outcomes

Other Outcomes (3)

  • Intensive Care unit (ICU) length of stay

    Time to event: from the date of hospital admission to the date of ICU discharge (up to 6 months)

  • Acute hospital length of stay

    Time to event: from the date of hospital admission to the date of hospital discharge (up to 12 months)

  • Discharge destination

    Event: date of hospital discharge (up to 12 months)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the ICU who are sufficiently awake and attentive (according to pre-determined awakening criteria) following at least 5 days of consecutive invasive mechanical ventilation

You may qualify if:

  • Adult patient ≥ 18 years of age
  • Patient is/was intubated (endotracheal, nasotracheal or tracheostomy) and required ≥ 5 days of mechanical ventilation (irrespective of reason for ventilatory support)

You may not qualify if:

  • Unable to ambulate independently (either with or without gait aids) at least 10 meters within the last 3 months
  • Ordinarily unable to understand written and spoken English sufficient to provide consent (e.g. due to non-English speaking background or pre-existing cognitive impairment)
  • Assessed by medical staff as approaching imminent death or withdrawal of medical management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Baldwin CE, Rowlands AV, Fraysse F, Johnston KN. The sedentary behaviour and physical activity patterns of survivors of a critical illness over their acute hospitalisation: An observational study. Aust Crit Care. 2020 May;33(3):272-280. doi: 10.1016/j.aucc.2019.10.006. Epub 2019 Dec 6.

MeSH Terms

Conditions

Motor ActivitySedentary BehaviorCritical Illness

Condition Hierarchy (Ancestors)

BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 29, 2016

Study Start

March 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 29, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share