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Table 1 Schedule for enrolment, data collection, interventions and outcome measures

From: Effects of early, combined endurance and resistance training in mechanically ventilated, critically ill patients: a study protocol for a randomised controlled trial

 

Enrolment

Allocation

Post allocation

Timepoint

ICU admission

 

ICU stay (daily)

ICU discharge

Hospital discharge

6-month follow-up

Enrolment:

 Eligibility screen

x

     

 Consent by nonparticipating doctor

x

     

 Allocation

 

x

    

 Informed consent by proxy

 

≤72 h

    

Data collection:

 Demographic and diagnostic data

 

x

    

 APACHE II score

x

     

 SOFA score

  

x

   

 TISS 28 and 76

x

  

x

  

 Laboratory findings

x

x

 

x

  

 Medication

  

x

   

Physiotherapy Interventions:

 Frequency, duration and content

  

x

   

 Safety and physiological parameters

  

x

   

 Mobility milestones

  

x

   

 Bed rest complications

  

x

   

 Serious/adverse events

  

x

   

Outcome measures:

 Muscle strength: MRC sum score, handgrip and quadriceps strength

   

x

  

 Range of motion

   

x

  

 Functional Independence Measure

   

x

x

 

 Length of stay (ICU and hospital), days on mechanical ventilation

    

x

 

 6-Minute Walk Test

    

x

 

 Timed ‘Up & Go’ Test

    

x

 

Short Form 36

     

x

  1. APACHE Acute Physiology and Chronic Health Evaluation, ICU intensive care unit, MRC Medical Research Council, SOFA Sequential Organ Failure Assessment score, TISS Therapeutic Intervention Scoring System