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

August 23, 2016 updated by: Claire Baldwin, University of South Australia

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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)
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
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
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
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 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.
Time to event: from the date of hospital admission to the date of hospital discharge (up to 12 months)
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.
Event: date of hospital discharge (up to 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Australia

Collaborators

University of Leicester
Australian Physiotherapy Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 29, 2016

Study Record Updates

Last Update Posted (Estimate)

August 29, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000032489
  • 91.41 (Other Identifier: Southern Adelaide Health Service)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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