The Effect of Exercise Dosage on Physical Function, Cognition and Disability Following Critical Illness

NCT03413189 | Unknown

• 1 other identifier: ANZICRC/PREDICTABLE/001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Critical Illness

Keywords

Exercise; Dosage; Function

Outcome Measures

Primary Outcomes (2)

• 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).

  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)

  Up to 6 months following ICU admission

Secondary Outcomes (4)

• To correlate patient reported functional outcomes EQ5D with objectively measured outcomes

  6 months after ICU admission

• To correlate patient reported functional outcomes WHODAS with objectively measured outcomes

  6 months after ICU admission

• Identify themes regarding recovery from critical illness from patient interviews

  6 months after ICU admission

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

  6 months after ICU admission

Study Arms (2)

PREDICT participants

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

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: Review of medical records; Other: Assessment of physical and cognitive function; Other: Interview of patients, carers and/or family members

Interventions

Review of medical records OTHER

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)

PREDICT participants; PREDITCABLE participants

Assessment of physical and cognitive function OTHER

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).

PREDITCABLE participants

Interview of patients, carers and/or family members OTHER

Questions will be asked to participants regarding their recovery from Intensive Care to establish themes

PREDITCABLE participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead
• Monash Health: collaborator
• Monash University: collaborator

Study Sites (3)

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Dandenong Hospital

Dandenong, Victoria, 3175, Australia

Location

Australian and New Zealand Intensive Care Research Centre

Melbourne, Victoria, 3004, Australia

Location

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MeSH Terms

Conditions

Critical Illness; Motor Activity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Carol Hodgson, A/Prof

  Australian and New Zealand intensive Care Reserch Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2017
• First Posted: January 29, 2018
• Study Start: March 9, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

AU (3)