Study protocol: home-based physical rehabilitation for survivors of a critical illness [ACTRN12605000166673]

Abstract

Introduction: Numerous primary studies and several review papers have highlighted delayed physical and psychological recovery for survivors of critical illness, often beyond 6 months after discharge. This randomized controlled trial with blinded assessment aims to test the effects of an 8-week, home-based, individually tailored physical rehabilitation programme on physical and psychological recovery for survivors of a critical illness after discharge from hospital.

Method: Participants are survivors of a critical illness discharged from nine intensive care units (ICUs) in Australia, who are aged 18 years or older, in an ICU longer than 48 hours, discharged home to self-care or carer (non-institutional care), able to participate in physical rehabilitation, and within the hospitals' local geographical areas for home visits. The study is based in participants' home environments. Blinded assessments at weeks 1, 8 and 26 after hospital discharge examine physical functioning, exercise capacity, health-related quality of life and psychological well being. The intervention is graded, individualized endurance and strength training prescribed by a pulmonary rehabilitation physiotherapist over an 8-week period, with three home visits, five follow-up phone calls, and a printed exercise manual supporting the training. Initial focus is on lower limb exercises and walking, with warm-up stretches, and progresses to the addition of core stabilization and upper limb exercises.

Results: The burden of a critical illness is well documented. This novel study will determine whether a home-based physical rehabilitation programme improves the recovery trajectory for survivors of critical illness. The projected sample size of 200 patients aims to detect a clinically important 10% improvement in physical functioning. The study will also examine whether other important physical and psychological measures are improved.

Conclusion: This multicentre, randomized controlled trial will examine outcomes that are meaningful to patients, their family and society, namely functional ability and well being. The study will also target a health problem that is likely to increase as the population ages. If the programme is effective, it will provide a model that can be easily adapted and adopted by existing primary care or community services to improve the recovery of individuals following critical illness.

Figure 1

Participant enrolment and retention flow diagram. ¹The inclusion criteria are as follows: age ≥18 years or older; intensive care unit length of stay >48 hours; receipt of mechanical ventilation for ≥24 hours; discharged home to self-care or carer; residence within the hospitals' local catchment areas to enable home visits; no neurological, spinal or skeletal dysfunction preventing participation in physical rehabilitation; not receiving palliative care; and no organised rehabilitation related to ongoing chronic disease.