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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881801
• Other study ID #: 0000032489
• Secondary ID: 91.41
• Status: Completed
• Phase: N/A
• First received: August 3, 2016
• Last updated: August 23, 2016
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: University of South Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Motor Activity
• Sedentary Lifestyle

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of South Australia	Australian Physiotherapy Research Foundation, University of Leicester

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intensive Care unit (ICU) length of stay	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)	No
Other	Acute hospital length of stay	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)	No
Other	Discharge destination	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	Peripheral muscle strength	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)	No
Secondary	Peripheral muscle strength	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)	No
Secondary	Peripheral muscle strength	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)	No
Secondary	Hand grip strength	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)	No
Secondary	Hand grip strength	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)	No
Secondary	Hand grip strength	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)	No
Secondary	Low level physical function/mobility	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)	No
Secondary	Low level physical function/mobility	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)	No
Secondary	Low level physical function/mobility	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)	No
Secondary	High level physical function/mobility	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)	No
Secondary	High level physical function/mobility	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)	No
Secondary	High level physical function/mobility	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)	No