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Trial record 7 of 7 for:    21946660 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT03413189
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : September 4, 2019
Sponsor:
Collaborators:
Monash Health
Monash University
Information provided by (Responsible Party):
Australian and New Zealand Intensive Care Research Centre

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.

Condition or disease Intervention/treatment
Critical Illness Other: Review of medical records Other: Assessment of physical and cognitive function Other: Interview of patients, carers and/or family members

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.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PREDICTABLE: The Effect of Exercise Dosage on Physical Function, Cognition and Disability Following Critical Illness
Actual Study Start Date : March 9, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).

  2. 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)


Secondary Outcome Measures :
  1. To correlate patient reported functional outcomes 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)

  2. To correlate patient reported functional outcomes 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 (FIM).

  3. To correlate patient reported functional outcomes 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).

  4. To correlate patient reported functional outcomes with objectively measured outcomes [ Time Frame: 6 months after ICU admission ]
    Compare patient reported disability score (WHODAS) with a gold standard functional outcome measure (FIM).

  5. Identify themes regarding recovery from critical illness from patient interviews [ Time Frame: 6 months after ICU admission ]
    Obtain qualitative data from patients and relatives/carers/next of kin to identify themes regarding the recovery process.

  6. To correlate patient reported cognitive outcomes with in person measured cognitive putcomes [ Time Frame: 6 months after ICU admission ]
    Compare patient reported MoCA Blind scores with those of the same test measured in person



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413189


Contacts
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Contact: Michelle Paton, MPhysio +61 3 9594 2250 michelle.paton@monashhealth.org
Contact: Rebecca Lane, A/Prof +61 3 5336 5540 rebecca.lane@acu.edu.au

Locations
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Australia, Victoria
Monash Medical Centre Recruiting
Clayton, Victoria, Australia, 3168
Contact: Michelle Paton, MPhysio    +61 3 9594 2250    michelle.paton@monashhealth.org   
Dandenong Hospital Recruiting
Dandenong, Victoria, Australia, 3175
Contact: Michelle Paton, MPhysio    +61 3 9594 2250    michelle.paton@moanshhealth.org   
Australian and New Zealand Intensive Care Research Centre Active, not recruiting
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Australian and New Zealand Intensive Care Research Centre
Monash Health
Monash University
Investigators
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Principal Investigator: Carol Hodgson, A/Prof Australian and New Zealand intensive Care Reserch Centre

Publications:

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Responsible Party: Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov Identifier: NCT03413189     History of Changes
Other Study ID Numbers: ANZICRC/PREDICTABLE/001
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Australian and New Zealand Intensive Care Research Centre:
Exercise
Dosage
Function
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes