Evaluation of Exercise Rehabilitation for Survivors of Intensive Care: Protocol for a Single Blind Randomised Controlled Trial

ABSTRACT

Intensive care (ICU) survivors have poor quality of life (QoL) and physical outcomes compared to people of the same age and sex [1]. Although rehabilitation of patients in ICU is now advocated as routine clinical practice [2] there are few randomised controlled trials (RCTs) examining patient outcomes. The primary aim of this single blind randomised controlled trial is to investigate the efficacy of a comprehensive rehabilitation intervention begun in ICU compared to standard care on health related quality of life (HRQoL) and physical function.

Participants who have been in one tertiary ICU for 􀀁 5 days, aged 􀀁18 years, who can understand written and spoken English, will be randomly allocated to receive either standard care or a comprehensive physiotherapy rehabilitation program beginning in ICU and continuing upon discharge to the ward and as an out patient (OP). Blinded assessment of the primary outcome measures physical function, health status and HRQoL will be performed at baseline, 3, 6 and 12 months after discharge. Physical function measures will be obtained at ICU and hospital discharge and for the intervention group, pre and post OP classes. The intervention will include individualised exercises prescribed by physiotherapists in ICU and on the ward and given by an exercise physiologist and physiotherapist in OP.

We aim to enrol 200 participants over two years. The study will determine whether comprehensive physiotherapy rehabilitation from ICU to discharge and OP attendance will improve physical functioning, health status and quality of life in critical care survivors. The cost utility (CUA) and cost effectiveness of such a program will also be evaluated using utility scores and a purpose designed economics questionnaire. Secondary outcomes related to proxy and subject HRQoL comparisons, mechanical ventilation, critical illness neuromyopathy, ICU readmission and discharge destination will also be examined.

The outcomes measured are of significance to critical care patients. The CUA of the intervention will be of interest to health service providers. The results will enable development of clinical practice guidelines for the appropriate exercises in survivors of ICU.

Registered with the Australian and New Zealand Clinical Trials Network [ACTRN 12605000776606].