Additionally, we will try to get all information about the content and duration of physiotherapy new product and or physical rehabilitation applied at all stages of illness. Measures and outcomes Primary outcomes of the GYMNAST study are walking ability and ability to stand up alone. To measure walking ability the functional ambulation categories (FAC)
is used.22 The ability to stand up alone will be measured by the ability to stand up from a chair independently, STS (standardised chair height is defined with 120% of knee height). Secondary outcomes includes: Richmond Agitation-Sedation Scale (RASS)21 Activities measured with the Barthel Index (BI; 10 items)23 Muscle strength of the upper (shoulder, elbow and wrist) and lower limb (hip, knee and ankle) using the Medical Research Council (MRC)1 24 Grip strength (measured bilaterally using a dynamometer)25 26 Functional Status Score for the
Intensive Care Unit Scored (FSS-ICU)27 Physical Function–ICU Test (PFIT)28 and Physical Function–ICU Test-Scored (PFIT-S)29 Pain using a visual analogue scale Lateral and frontal sit and stance balance (functional reach)30 31 Cognitive measures (Montreal Cognitive Assessment (MoCA)32 and clock drawing test (CDT)33 Walking ability (0–5; FAC),34 walking speed (we will use a 10 m walking test, adopting a 14 m course and will measure the walking speed over the central 10 m) and walking endurance (we will use a 6 min walking test, using 40 m course and will measure the distance walked in 6 min; if patients cannot walk the whole 6 min we will measure the maximum walking distance here)5 6 Quality of life (EQ-5D)35 Participation
(Reintegration to Normal Living, RNL-Index)36 37 Fitness and mobility (PASIPD)38 39 All measures chosen are frequently used in research and/or daily clinical practice dealing with the above described patients. The primary outcome variables FAC and STS will be measured daily with standardised sheets for this purpose. At baseline Brefeldin_A assessment (T0) and then every 2 weeks until 20 weeks after baseline (T10) we will assess RASS, BI, muscle strength of the upper and lower limb (MRC), grip strength, FSS-ICU, PFIT and PFIT-S, pain, functional reach, cognitive measures, walking speed and endurance. At follow-ups FU1 after 6-month and FU2 after 1 year after study entry we will measure the EQ-5D, the RNL-Index and PASIPD. Additionally we will be gathering detailed survival data. Table 1 gives a detailed overview of the variables used at each time point of study. Table 1 Summary of outcome measures and time points of assessment in GymNAST Possible clinical prognostic factors Depending on the primary outcomes (walking ability and activities), a range of potentially prognostic factors will be taken into account.
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