Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03413189




Registration number
NCT03413189
Ethics application status
Date submitted
12/11/2017
Date registered
29/01/2018
Date last updated
15/09/2023

Titles & IDs
Public title
The Effect of Exercise Dosage on Physical Function, Cognition and Disability Following Critical Illness
Scientific title
PREDICTABLE: The Effect of Exercise Dosage on Physical Function, Cognition and Disability Following Critical Illness
Secondary ID [1] 0 0
ANZICRC/PREDICTABLE/001
Universal Trial Number (UTN)
Trial acronym
PREDICTABLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Review of medical records
Other interventions - Assessment of physical and cognitive function
Other interventions - Interview of patients, carers and/or family members

PREDICT participants - This cohort is obtained from the PREDICT study enrolment (approx. 500) and a review of their medical records will be conducted

PREDITCABLE participants - 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 interventions: Review of medical records
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)

Other interventions: Assessment of physical and cognitive function
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).

Other interventions: Interview of patients, carers and/or family members
Questions will be asked to participants regarding their recovery from Intensive Care to establish themes
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The measure the effect of exercise dosage in critical care on physical function
Timepoint [1] 0 0
6 months after ICU admission
Primary outcome [2] 0 0
The measure the effect of exercise dosage in critical care on cognitive function
Timepoint [2] 0 0
Up to 6 months following ICU admission
Secondary outcome [1] 0 0
To correlate patient reported functional outcomes EQ5D with objectively measured outcomes
Timepoint [1] 0 0
6 months after ICU admission
Secondary outcome [2] 0 0
To correlate patient reported functional outcomes WHODAS with objectively measured outcomes
Timepoint [2] 0 0
6 months after ICU admission
Secondary outcome [3] 0 0
Identify themes regarding recovery from critical illness from patient interviews
Timepoint [3] 0 0
6 months after ICU admission
Secondary outcome [4] 0 0
To correlate patient reported cognitive outcomes with in person measured cognitive outcomes
Timepoint [4] 0 0
6 months after ICU admission

Eligibility
Key inclusion criteria
- ICU patients who have been invasively mechanically ventilated for over 24 hours
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Dandenong Hospital - Dandenong
Recruitment hospital [3] 0 0
Australian and New Zealand Intensive Care Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3175 - Dandenong
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03413189
Trial related presentations / publications
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Hopkins RO, Herridge MS. Quality of life, emotional abnormalities, and cognitive dysfunction in survivors of acute lung injury/acute respiratory distress syndrome. Clin Chest Med. 2006 Dec;27(4):679-89; abstract x. doi: 10.1016/j.ccm.2006.06.003.
Hopkins RO, Suchyta MR, Farrer TJ, Needham D. Improving post-intensive care unit neuropsychiatric outcomes: understanding cognitive effects of physical activity. Am J Respir Crit Care Med. 2012 Dec 15;186(12):1220-8. doi: 10.1164/rccm.201206-1022CP. Epub 2012 Oct 11.
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Public notes

Contacts
Principal investigator
Name 0 0
Carol Hodgson, A/Prof
Address 0 0
Australian and New Zealand intensive Care Reserch Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03413189