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

Critical Illness Clinical Trial

— PREDICTABLE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03413189
• Other study ID #: ANZICRC/PREDICTABLE/001
• Status: Active, not recruiting
• Start date: March 9, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

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)
• 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).
• Interview of patients, carers and/or family members
Questions will be asked to participants regarding their recovery from Intensive Care to establish themes

Locations

Country	Name	City	State
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Dandenong Hospital	Dandenong	Victoria
Australia	Australian and New Zealand Intensive Care Research Centre	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre	Monash Health, Monash University

Country where clinical trial is conducted

Australia, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

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