Clinical trial NCT02881801: Patterns of Physical Activity and Sedentary Time in Survivors of a Critical Illness During a Hospital Admission
Official title: Patterns of Physical Activity and Sedentary Time in Survivors of a Critical Illness During a Hospital Admission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Motor Activity
Sedentary Lifestyle
Critical Illness
Keywords: accelerometry
Lead sponsor: University of South Australia
Sponsor class: OTHER
Collaborators: name: Australian Physiotherapy Research Foundation
name: University of Leicester
First posted: 2016-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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

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. 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical activity time
timeFrame: 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)
measure: Physical activity bouts
timeFrame: 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)
measure: Sedentary time
timeFrame: 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)
measure: Sedentary bouts
timeFrame: 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)
measure: Physical activity time
timeFrame: 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)
measure: Physical activity bouts
timeFrame: 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)
measure: Sedentary time
timeFrame: 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)
measure: Sedentary bouts
timeFrame: 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)
measure: Physical activity time
timeFrame: 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)
measure: Physical activity bouts
timeFrame: 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)
measure: Sedentary time
timeFrame: 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)
measure: Sedentary bouts
timeFrame: 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:
measure: Peripheral muscle strength
timeFrame: 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)
measure: Peripheral muscle strength
timeFrame: 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)
measure: Peripheral muscle strength
timeFrame: 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)
measure: Hand grip strength
timeFrame: 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)
measure: Hand grip strength
timeFrame: 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)
measure: Hand grip strength
timeFrame: 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)
measure: Low level physical function/mobility
timeFrame: 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)
measure: Low level physical function/mobility
timeFrame: 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)
measure: Low level physical function/mobility
timeFrame: 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)
measure: High level physical function/mobility
timeFrame: 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)
measure: High level physical function/mobility
timeFrame: 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)
measure: High level physical function/mobility
timeFrame: 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)
Other outcomes:
measure: Intensive Care unit (ICU) length of stay
timeFrame: Time to event: from the date of hospital admission to the date of ICU discharge (up to 6 months)
measure: Acute hospital length of stay
timeFrame: Time to event: from the date of hospital admission to the date of hospital discharge (up to 12 months)
measure: Discharge destination
timeFrame: Event: date of hospital discharge (up to 12 months)
Locations:
Study officials:
References:
citation: 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.