Dose of Early Therapeutic Mobility: Does Type or Frequency Matter?
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      This study will examine the effects of once and twice daily activity performed with patients
      who are breathing with the aid of a machine in an intensive care unit. Activity can occur in
      bed. Activity can include transfer to a chair and even walking once the patient's condition
      allows safe, out-of-bed activity. The investigators hypothesize that early, progressive
      activity will reduce inflammatory molecules in the blood, promote muscle and physical health
      and help patients to recover more quickly from critical illness.
    

Detailed description: 
      Early therapeutic mobility (ETM) activity has been recommended to facilitate recovery and
      improve outcomes for the survivors of critical illness who experience prolonged mechanical
      ventilation. The effective dose (i.e., type, frequency and duration) of ETM activity is not
      known and there are limited reports about the application and effects of ETM in mechanically
      ventilated intensive care unit (ICU) patients. Three inflammatory biomarkers, interleukin
      (IL)-6, IL-10 and C-reactive protein, are potentially altered by a single episode of ETM
      activity. Systemic markers of physical health (i.e., vital signs, delirium, muscle strength,
      ventilator associated pneumonia, and duration of mechanical ventilation) may also be
      positively influenced by ETM. The primary aim of this interdisciplinary study is to compare
      the immediate effects of frequency--single and twice daily episodes--of ETM activity and the
      effects of type--low and moderate intensity--of ETM activity on molecular biomarkers of
      inflammation and systemic markers of physical health in mechanically ventilated adults. This
      is an experimental design, using repeated measures; subjects will be randomized to receive
      either one or two episodes of ETM activity daily during week days while in the ICU. Type of
      activity will be determined by patient condition. The research questions are:

        1. a. What are the differences between the frequency (once versus twice daily) of ETM
           activities on inflammatory biomarkers: interleukin (IL)-6, IL-10 and C-reactive protein
           (CRP)? 1.b. What are the differences between the type (low or moderate) of ETM
           activities on inflammatory biomarkers: IL-6, IL-10 and CRP?

        2. a. What are the differences between frequency of ETM activities on systemic markers of
           physical health: vital signs, delirium, muscle strength, ventilator-associated pneumonia
           and duration of mechanical ventilation? 2.b. What are the differences between type of
           ETM activities on systemic markers of physical health: vital signs, delirium, muscle
           strength, ventilator-associated pneumonia and duration of mechanical ventilation?

      Data will be collected for a maximum of 3 contiguous days in ICU patients who are
      mechanically ventilated for >48 hours, then weekly to examine short-term patient responses to
      ETM activities in this preliminary study. Daily episodes of activity will be provided by a
      study interventionist. Repeated measures MANCOVA and ANCOVA will be used to answer the
      research questions. This collaborative study evaluates a biobehavioral methodology within an
      interdisciplinary team consistent with the biobehavioral methods to improve outcome research
      (PA-07-008) and the mission of the National Institute of Nursing Research to improve
      treatments and health based on evidence.
    

Intervention name(s): once daily mobility activity; twice daily mobility activity
Intervention type(s): Procedure; Procedure
Intervention description(s): in bed and out-of-bed activity including range of motion, chair sitting, sitting at edge of bed without weightbearing, standing, walking.; as with once daily. Goal is to progress intensity and duration of activity over time as patient condition improves for both arms
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: critical care; inflammatory biomarkers; cytokines; mechanical ventilation; activity; mobility therapy; More than 48 hours of mechanical ventilation