Skip to main content
OpenTrials
Completed

NCT Number: NCT02881801

Patterns of Physical Activity and Sedentary Time in Survivors of a Critical Illness During a Hospital Admission

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. Determine the duration of active and sedentary parameters including time and bouts in 24 hour periods 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. Conduct a preliminary examination of relationships between activity and sedentary behaviour metrics with measures of muscle strength, physical function and hospital length of stay.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Motor Activity Behavior Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Sedentary Behavior Sedentary Lifestyle

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This is a prospective observational study that consecutively samples eligible patients with a critical illness, requiring intensive care. This study will use two activity monitors (accelerometers) to measure physical activity and sedentary variables from patients recovering from a critical illness in a single tertiary hospital on three occasions during their acute hospital admission. Accelerometer derived measures will be obtained from continuous 24 hour monitoring periods once patients are sufficiently awake and attentive within the ICU, at ICU discharge and again at acute hospital discharge. Measurements of patients muscle strength and physical function will also be made at the time of accelerometry.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Physical activity time

    Time frame: 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)

    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)

  2. Physical activity bouts

    Time frame: 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)

    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)

  3. Sedentary time

    Time frame: 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)

    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)

  4. Sedentary bouts

    Time frame: 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)

    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)

  5. Physical activity time

    Time frame: 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)

    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)

  6. Physical activity bouts

    Time frame: 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)

    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)

  7. Sedentary time

    Time frame: 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)

    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)

  8. Sedentary bouts

    Time frame: 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)

    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)

  9. Physical activity time

    Time frame: 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)

    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)

  10. Physical activity bouts

    Time frame: 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)

    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)

  11. Sedentary time

    Time frame: 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)

    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)

  12. Sedentary bouts

    Time frame: 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)

    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)

Secondary outcomes

  1. Peripheral muscle strength

    Time frame: 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)

    Assessed with the medical research council (MRC) sum score, reported as a raw score /60 and categorically (yes/no) to indicate the presence of ICU acquired weakness (scores < 48/60 indicative of clinically significant weakness)

  2. Peripheral muscle strength

    Time frame: 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)

    Assessed with the medical research council (MRC) sum score, reported as a raw score /60 and categorically (yes/no) to indicate the presence of ICU acquired weakness (scores < 48/60 indicative of clinically significant weakness)

  3. Peripheral muscle strength

    Time frame: 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)

    Assessed with the medical research council (MRC) sum score, reported as a raw score /60 and categorically (yes/no) to indicate the presence of ICU acquired weakness (scores < 48/60 indicative of clinically significant weakness)

  4. Hand grip strength

    Time frame: 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)

    Assessed with hand grip dynamometry in kilograms

  5. Hand grip strength

    Time frame: 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)

    Assessed with hand grip dynamometry in kilograms

  6. Hand grip strength

    Time frame: 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)

    Assessed with hand grip dynamometry in kilograms

  7. Low level physical function/mobility

    Time frame: 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)

    Assessed with the PFIT (physical function in ICU test), reported as an interval score /10

  8. Low level physical function/mobility

    Time frame: 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)

    Assessed with the PFIT (physical function in ICU test), reported as an interval score /10

  9. Low level physical function/mobility

    Time frame: 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)

    Assessed with the PFIT (physical function in ICU test), reported as an interval score /10

  10. High level physical function/mobility

    Time frame: 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)

    Assessed with the DEMMI (deMorton mobility index), reported as an interval score /100

  11. High level physical function/mobility

    Time frame: 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)

    Assessed with the DEMMI (deMorton mobility index), reported as an interval score /100

  12. High level physical function/mobility

    Time frame: 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)

    Assessed with the DEMMI (deMorton mobility index), reported as an interval score /100

Other outcomes

  1. Intensive Care unit (ICU) length of stay

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

    Based on hospital record data, reported in number of days. Associations with primary outcomes to be reported.

  2. Acute hospital length of stay

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

    Based on hospital record data, reported in number of days. Associations with primary outcomes to be reported.

  3. Discharge destination

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

    Based on hospital record data, categorised as home, inpatient rehabilitation, another acute/community hospital, nursing home, other. Associations with primary outcomes to be reported.

Sponsors and collaborators

Lead sponsor

University of South Australia

Other

Collaborators

  • Australian Physiotherapy Research Foundation
  • University of Leicester

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 29, 2016
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.