Clinical trial NCT03413189: The Effect of Exercise Dosage on Physical Function, Cognition and Disability Following Critical Illness
Official title: PREDICTABLE: The Effect of Exercise Dosage on Physical Function, Cognition and Disability Following Critical Illness
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Critical Illness
Keywords: Exercise
Dosage
Function
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
Collaborators: name: Monash Health
name: Monash University
First posted: 2018-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients who were mechanically ventilated \> 24 hours in an intensive care unit who have survived to hospital discharge.

Brief summary: Survival following a critical illness continues to improve with ongoing developments in medical management, however evidence shows that this patient group is at a high risk of suffering long term disability. The objectives are to determine if there is a link between the amount of exercise performed in intensive care on the presence of delirium, long term cognition and disability whilst ensuring that patient reported outcomes correlate with actual measured results, and to obtain information on recovery from patients and/or relatives to determine themes.

Detailed description: Survival from a critical illness is increasing, however the long term effect on patient's quality of life and the ability for patients to return to pre-illness function is unfavourable. Exercise in the ICU has been proven to be safe and effective, with decreases in length of stay and improvements in physical and psychosocial function seen in multiple studies. At present, the investigators are unsure on the most effective way to exercise this patient group in relation to duration, type, intensity and frequency.

The investigators aim to link the presence of delirium during an ICU admission, disability-free survival and quality of life obtained from telephone follow-up six months following ICU discharge with the amount of exercise performed during their ICU stay to determine a relationship. Additionally, in a small group of participants, the investigators will measure cognitive and physical function to ensure that the patient reported data accurately reflects their true functional level, while allowing patients and/or relatives, next of kin or carers to provide information regarding their recovery through an interview process.

The measure of physical function and disability (via the WHODAS and Euro Qol Group Health Survey (EQ5D)) obtained during telephone interview of the 500 patients enrolled in the PREDICT study will be correlated with the amount of exercise they performed whilst in Intensive Care obtained from the medical records. The presence of delirium will also be obtained from the medical records and linked with the amount of exercise performed to determine if a link is present. A sub-set of this population (40) will be invited at the 3-month follow up phone call of the PREDICT study to have a physiotherapist visit them to assess their cognitive and physical function and interview them and/or their relatives, next of kin or carer to determine themes of the recovery process following critical illness.

Eligibility criteria: Inclusion Criteria:

- ICU patients who have been invasively mechanically ventilated for over 24 hours

Exclusion Criteria:

* Patients aged less than 18 years old
* A proven or suspected acute primary brain process that is likely to result in global impairment of conscious level or cognition (e.g. Traumatic Brain Injury, Subarachnoid Haemorrhage, stroke or hypoxic brain injury after cardiac arrest)
* Second or subsequent admission to ICU during a single hospital admission
* Death is deemed imminent and inevitable
* Participants who do no not speak English

Primary outcomes:
measure: The measure the effect of exercise dosage in critical care on physical function
timeFrame: 6 months after ICU admission
measure: The measure the effect of exercise dosage in critical care on cognitive function
timeFrame: Up to 6 months following ICU admission
Secondary outcomes:
measure: To correlate patient reported functional outcomes EQ5D with objectively measured outcomes
timeFrame: 6 months after ICU admission
measure: To correlate patient reported functional outcomes WHODAS with objectively measured outcomes
timeFrame: 6 months after ICU admission
measure: Identify themes regarding recovery from critical illness from patient interviews
timeFrame: 6 months after ICU admission
measure: To correlate patient reported cognitive outcomes with in person measured cognitive outcomes
timeFrame: 6 months after ICU admission
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Dandenong
country: Australia
facility: Dandenong Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Australian and New Zealand Intensive Care Research Centre
state: Victoria
Study officials:
affiliation: Australian and New Zealand intensive Care Reserch Centre
name: Carol Hodgson, A/Prof
role: PRINCIPAL_INVESTIGATOR
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