An observational study in Critical Illness, sponsored by Australian and New Zealand Intensive Care Research Centre. Active, not recruiting at 3 sites in Australia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Australian and New Zealand Intensive Care Research Centre · Observational
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.
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.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's planned enrollment of 40 is below the median of 140 across 814 observational studies indexed under Critical Illness.
Browse Critical Illness studies →Australian and New Zealand Intensive Care Research Centre is the lead sponsor of 49 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Critically ill patients who were mechanically ventilated > 24 hours in an intensive care unit who have survived to hospital discharge.
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Exclusion Criteria:
This cohort is obtained from the PREDICT study enrolment (approx. 500) and a review of their medical records will be conducted
Other: Review of medical records
This is a nested cohort of patients recruited into PREDICT (approx. 40) that consent for a physiotherapist home visit to assess their physical and cognitive function and perform and interview to obtain themes regarding recovery
Other: Review of medical records · Other: Assessment of physical and cognitive function · Other: Interview of patients, carers and/or family members
Medical records of patients will be reviewed to establish the median and highest level of functional achieved in Intensive Care (intensity) and the percentage of exercise sessions performed (frequency)
This will be performed in person through the Function Independence Measure (FIM), grip strength, functional reach, 6-minute walk test (6MWT) and Montreal Cognitive Assessment (MoCA-Blind).
Questions will be asked to participants regarding their recovery from Intensive Care to establish themes
The measure the effect of exercise dosage in critical care on physical function
To correlate the amount of exercise performed in ICU on objectively measured physical function at 6 months following ICU admission (via 6MWT and FIM).
Time frame: 6 months after ICU admission
The measure the effect of exercise dosage in critical care on cognitive function
To correlate the amount of exercise performed in ICU on cognitive function (via MoCA Blind)
Time frame: Up to 6 months following ICU admission
To correlate patient reported functional outcomes EQ5D with objectively measured outcomes
Compare patient reported disability score (EQ-5D) with a gold standard functional outcome measure (6MWT and FIM)
Time frame: 6 months after ICU admission
To correlate patient reported functional outcomes WHODAS with objectively measured outcomes
Compare patient reported disability score (WHODAS) with a gold standard functional outcome measure (6MWT and FIM).
Time frame: 6 months after ICU admission
Identify themes regarding recovery from critical illness from patient interviews
Compare qualitative data from patients and relatives/carers/next of kin to identify themes regarding the recovery process.
Time frame: 6 months after ICU admission
To correlate patient reported cognitive outcomes with in person measured cognitive outcomes
Compare patient reported MoCA Blind scores with those of the same test measured in person
Time frame: 6 months after ICU admission
Ran from Mar 2018 to primary completion in Dec 2020, 33 months.
Of 439 non-industry observational studies under Critical Illness, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's 33 months is above that.
Counting every sponsor, half of 442 studies reached it within 23 months; a quarter within 12 and three quarters within 46.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Australian and New Zealand Intensive Care Research Centre