NCT00999011

Dose of Early Therapeutic Mobility: Does Type or Frequency Matter?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Illness

Interventions

Type	Name	Description
PROCEDURE	once daily mobility activity	in bed and out-of-bed activity including range of motion, chair sitting, sitting at edge of bed without weightbearing, standing, walking.
PROCEDURE	twice daily mobility activity	as with once daily. Goal is to progress intensity and duration of activity over time as patient condition improves for both arms

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-06-01
• Completion: 2013-03-01
• First posted: 2009-10-21
• Last updated: 2022-03-31

Locations

1 site across 1 country: United States