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

September 13, 2023 updated by: Australian and New Zealand Intensive Care Research Centre

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Dandenong, Victoria, Australia, 3175
        • Dandenong Hospital
      • Melbourne, Victoria, Australia, 3004
        • Australian and New Zealand Intensive Care Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)
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
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: 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: Interview of patients, carers and/or family members
Questions will be asked to participants regarding their recovery from Intensive Care to establish themes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The measure the effect of exercise dosage in critical care on physical function
Time Frame: 6 months after ICU admission
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
Time Frame: Up to 6 months following ICU admission
To correlate the amount of exercise performed in ICU on cognitive function (via MoCA Blind)
Up to 6 months following ICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To correlate patient reported functional outcomes EQ5D with objectively measured outcomes
Time Frame: 6 months after ICU admission
Compare patient reported disability score (EQ-5D) with a gold standard functional outcome measure (6MWT and FIM)
6 months after ICU admission
To correlate patient reported functional outcomes WHODAS with objectively measured outcomes
Time Frame: 6 months after ICU admission
Compare patient reported disability score (WHODAS) with a gold standard functional outcome measure (6MWT and FIM).
6 months after ICU admission
Identify themes regarding recovery from critical illness from patient interviews
Time Frame: 6 months after ICU admission
Compare qualitative data from patients and relatives/carers/next of kin to identify themes regarding the recovery process.
6 months after ICU admission
To correlate patient reported cognitive outcomes with in person measured cognitive outcomes
Time Frame: 6 months after ICU admission
Compare patient reported MoCA Blind scores with those of the same test measured in person
6 months after ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Australian and New Zealand Intensive Care Research Centre

Collaborators

Monash University
Monash Health

Investigators

  • Principal Investigator: Carol Hodgson, A/Prof, Australian and New Zealand intensive Care Reserch Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2018

Primary Completion (Actual)

December 30, 2020

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

November 12, 2017

First Submitted That Met QC Criteria

January 22, 2018

First Posted (Actual)

January 29, 2018

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANZICRC/PREDICTABLE/001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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