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

Active, not recruiting

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

• Registration Number: NCT03413189
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-11-12
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Study Start: 2018-03-09
• Primary Completion: 2020-12-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-15
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PREDITCABLE participants	Interview of patients, carers and/or family members	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
PREDICT participants	Review of medical records	This cohort is obtained from the PREDICT study enrolment (approx. 500) and a review of their medical records will be conducted
PREDITCABLE participants	Review of medical records	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
PREDITCABLE participants	Assessment of physical and cognitive function	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

Primary Outcome Measures

Name	Time	Method
The measure the effect of exercise dosage in critical care on cognitive function	Up to 6 months following ICU admission	To correlate the amount of exercise performed in ICU on cognitive function (via MoCA Blind)
The measure the effect of exercise dosage in critical care on physical function	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).

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Monash Medical Centre; 🇦🇺 Clayton, Victoria, Australia

Dandenong Hospital; 🇦🇺 Dandenong, Victoria, Australia

Australian and New Zealand Intensive Care Research Centre; 🇦🇺 Melbourne, Victoria, Australia