The EXERCISE trial

Recruiting

• Conditions: ICU survivors; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12605000776606
• Lead Sponsor: Dr Linda Denehy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

ICU LOS of 5 or more days, able to understand written and spoken English, reside in greater Melbourne defined as within a radius of 50km from Austin Health in Heidelberg.

Exclusion Criteria

Neurological permanent weakness/conditions where exercise is contraindicated. Assessed by medical staff as approaching imminent death or withdrawal of medical management is being considered within 48 hours. Patients who have an ICU length of stay greater than 5 days due solely to ward bed blockages. Patients who would have been unable to perform the study physical outcome measures pre-morbidly due to a condition impairing their mobility.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6 Minute Walk Test[ICU discharge, discharge home, 8-10 weeks post hospital discharge, 6 and 12 months post ICU discharge.];Quality of Life (SF-36v2) to measure the health status of participants.[Baseline, 8-10 weeks post hospital discharge, 6 and 12 months post ICU discharge.];AQoL[Baseline, 8-10 weeks post hospital discharge, 6 and 12 months post ICU discharge.];Economic evaluation to allow a cost-effectiveness and cost utility analysis of the intervention.[8-10 weeks post hospital discharge, 6 and 12 months post ICU discharge.];'MUSCLE' test - test found to be reliable and responsive to change in pilot study (Skinner et al in press).[Baseline and ICU discharge];Timed up and go test (TUG)[ICU discharge, discharge home, 8-10 weeks post hospital discharge, 6 and 12 months post ICU discharge.];free living activity levels (accelerometer and Physical Activity Scale for the Elderley)[4-5 weeks post discharge home]

Secondary Outcome Measures

Name	Time	Method
Hours of mechanical ventilation[reported at the completion of the trial];ICU hours[reported at the completion of the trial];ICU readmission[reported at the completion of the trial];correlation between proxy and patient completion of HRQoL questionnaires[8-10 weeks post hospital discharge, 6 and 12 months post ICU discharge.]