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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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]

ANZICRC/PREDICTABLE/001

Universal Trial Number (UTN)

Trial acronym

PREDICTABLE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Critical Illness

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]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

The measure the effect of exercise dosage in critical care on physical function

Timepoint [1]

6 months after ICU admission

Primary outcome [2]

The measure the effect of exercise dosage in critical care on cognitive function

Timepoint [2]

Up to 6 months following ICU admission

Secondary outcome [1]

To correlate patient reported functional outcomes EQ5D with objectively measured outcomes

Timepoint [1]

6 months after ICU admission

Secondary outcome [2]

To correlate patient reported functional outcomes WHODAS with objectively measured outcomes

Timepoint [2]

6 months after ICU admission

Secondary outcome [3]

Identify themes regarding recovery from critical illness from patient interviews

Timepoint [3]

6 months after ICU admission

Secondary outcome [4]

To correlate patient reported cognitive outcomes with in person measured cognitive outcomes

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton

Recruitment hospital [2]

Dandenong Hospital - Dandenong

Recruitment hospital [3]

Australian and New Zealand Intensive Care Research Centre - Melbourne

Recruitment postcode(s) [1]

3168 - Clayton

Recruitment postcode(s) [2]

3175 - Dandenong

Recruitment postcode(s) [3]

3004 - Melbourne

Funding & Sponsors

Primary sponsor type

Other

Name

Australian and New Zealand Intensive Care Research Centre

Address

Country

Other collaborator category [1]

Other

Name [1]

Monash Health

Address [1]

Country [1]

Other collaborator category [2]

Other

Name [2]

Monash University

Address [2]

Country [2]

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/study/NCT03413189

Trial related presentations / publications

Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
Angus DC, Musthafa AA, Clermont G, Griffin MF, Linde-Zwirble WT, Dremsizov TT, Pinsky MR. Quality-adjusted survival in the first year after the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2001 May;163(6):1389-94. doi: 10.1164/ajrccm.163.6.2005123.
Thomas HC, Scully LJ, Lever AM, Yap I, Pignatelli M. A review of the efficacy of adenine arabinoside and lymphoblastoid interferon in the Royal Free Hospital studies of hepatitis B virus carrier treatment: identification of factors influencing response rates. Infection. 1987;15 Suppl 1:S26-31. doi: 10.1007/BF01650108.
Barnato AE, Albert SM, Angus DC, Lave JR, Degenholtz HB. Disability among elderly survivors of mechanical ventilation. Am J Respir Crit Care Med. 2011 Apr 15;183(8):1037-42. doi: 10.1164/rccm.201002-0301OC. Epub 2010 Nov 5.
Berney SC, Harrold M, Webb SA, Seppelt I, Patman S, Thomas PJ, Denehy L. Intensive care unit mobility practices in Australia and New Zealand: a point prevalence study. Crit Care Resusc. 2013 Dec;15(4):260-5.
Cheung AM, Tansey CM, Tomlinson G, Diaz-Granados N, Matte A, Barr A, Mehta S, Mazer CD, Guest CB, Stewart TE, Al-Saidi F, Cooper AB, Cook D, Slutsky AS, Herridge MS. Two-year outcomes, health care use, and costs of survivors of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Sep 1;174(5):538-44. doi: 10.1164/rccm.200505-693OC. Epub 2006 Jun 8.
Cuthbertson BH, Elders A, Hall S, Taylor J, MacLennan G, Mackirdy F, Mackenzie SJ; Scottish Critical Care Trials Group; Scottish Intensive Care Society Audit Group. Mortality and quality of life in the five years after severe sepsis. Crit Care. 2013 Apr 16;17(2):R70. doi: 10.1186/cc12616.
Cuthbertson BH, Roughton S, Jenkinson D, Maclennan G, Vale L. Quality of life in the five years after intensive care: a cohort study. Crit Care. 2010;14(1):R6. doi: 10.1186/cc8848. Epub 2010 Jan 20.
Dowdy DW, Eid MP, Dennison CR, Mendez-Tellez PA, Herridge MS, Guallar E, Pronovost PJ, Needham DM. Quality of life after acute respiratory distress syndrome: a meta-analysis. Intensive Care Med. 2006 Aug;32(8):1115-24. doi: 10.1007/s00134-006-0217-3. Epub 2006 Jun 17.
Dowrick AS, Gabbe BJ, Williamson OD, Wolfe R, Cameron PA. A comparison of self-reported and independently observed disability in an orthopedic trauma population. J Trauma. 2006 Dec;61(6):1447-52. doi: 10.1097/01.ta.0000242219.02901.d9.
Gabbe BJ, Cameron PA. Importance of functional and quality of life outcomes in trauma. Surgeon. 2013 Apr;11(2):114. doi: 10.1016/j.surge.2012.11.002. Epub 2012 Nov 27. No abstract available.
Hashem MD, Nallagangula A, Nalamalapu S, Nunna K, Nausran U, Robinson KA, Dinglas VD, Needham DM, Eakin MN. Patient outcomes after critical illness: a systematic review of qualitative studies following hospital discharge. Crit Care. 2016 Oct 26;20(1):345. doi: 10.1186/s13054-016-1516-x.
Herridge MS, Batt J, Hopkins RO. The pathophysiology of long-term neuromuscular and cognitive outcomes following critical illness. Crit Care Clin. 2008 Jan;24(1):179-99, x. doi: 10.1016/j.ccc.2007.11.002.
Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
Hodgson CL, Berney S, Harrold M, Saxena M, Bellomo R. Clinical review: early patient mobilization in the ICU. Crit Care. 2013 Feb 28;17(1):207. doi: 10.1186/cc11820.
Hodgson CL, Hayes K, Everard T, Nichol A, Davies AR, Bailey MJ, Tuxen DV, Cooper DJ, Pellegrino V. Long-term quality of life in patients with acute respiratory distress syndrome requiring extracorporeal membrane oxygenation for refractory hypoxaemia. Crit Care. 2012 Oct 19;16(5):R202. doi: 10.1186/cc11811.
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.
Innerd P, Catt M, Collerton J, Davies K, Trenell M, Kirkwood TB, Jagger C. A comparison of subjective and objective measures of physical activity from the Newcastle 85+ study. Age Ageing. 2015 Jul;44(4):691-4. doi: 10.1093/ageing/afv062. Epub 2015 May 27.
Iwashyna TJ. Trajectories of recovery and dysfunction after acute illness, with implications for clinical trial design. Am J Respir Crit Care Med. 2012 Aug 15;186(4):302-4. doi: 10.1164/rccm.201206-1138ED. No abstract available.
Kayambu G, Boots R, Paratz J. Physical therapy for the critically ill in the ICU: a systematic review and meta-analysis. Crit Care Med. 2013 Jun;41(6):1543-54. doi: 10.1097/CCM.0b013e31827ca637.
Kulkarni HS, Kulkarni KR, Mallampalli A, Parkar SR, Karnad DR, Guntupalli KK. Comparison of anxiety, depression, and post-traumatic stress symptoms in relatives of ICU patients in an American and an Indian public hospital. Indian J Crit Care Med. 2011 Jul;15(3):147-56. doi: 10.4103/0972-5229.84891.
Lacruz M, Emeny R, Bickel H, Linkohr B, Ladwig Kh. Feasibility, internal consistency and covariates of TICS-m (telephone interview for cognitive status-modified) in a population-based sample: findings from the KORA-Age study. Int J Geriatr Psychiatry. 2013 Sep;28(9):971-8. doi: 10.1002/gps.3916. Epub 2012 Nov 28.
Lea GS, Costello R. Developing an Intensive Care Continuum: incorporating rehabilitation services in critical care. Dimens Crit Care Nurs. 1997 Jan-Feb;16(1):40-6. doi: 10.1097/00003465-199701000-00005.
Lee JJ, Waak K, Grosse-Sundrup M, Xue F, Lee J, Chipman D, Ryan C, Bittner EA, Schmidt U, Eikermann M. Global muscle strength but not grip strength predicts mortality and length of stay in a general population in a surgical intensive care unit. Phys Ther. 2012 Dec;92(12):1546-55. doi: 10.2522/ptj.20110403. Epub 2012 Sep 13.
Luciano JV, Ayuso-Mateos JL, Fernandez A, Serrano-Blanco A, Roca M, Haro JM. Psychometric properties of the twelve item World Health Organization Disability Assessment Schedule II (WHO-DAS II) in Spanish primary care patients with a first major depressive episode. J Affect Disord. 2010 Feb;121(1-2):52-8. doi: 10.1016/j.jad.2009.05.008. Epub 2009 May 22.
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Public notes

Contacts

Principal investigator

Name

Carol Hodgson, A/Prof

Address

Australian and New Zealand intensive Care Reserch Centre

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03413189

Trial Review

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