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Investigating Modes of Progressive Mobility

NCT00787098 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2009-07-03

No results posted yet for this study

Summary

The purpose of this study is to compare the effects of specific activities with and without an early therapeutic mobility (ETM) protocol among patients who experience three or more days of mechanical ventilation. A second purpose is to examine staff/delivery system and patient factors that influence the initiation and progression of activity with and without an ETM protocol. The hypothesis is that ETM protocols will result in improved patient outcomes.

Conditions

  • Critical Care
  • Mechanical Ventilation
  • Intensive Care
  • Muscular Atrophy

Interventions

OTHER

ETM protocol

ETM is 4 levels. Level 1, each receives repositioning from lateral to supine positions at even hours, totaling 60 minutes of activity/positioning over 24 hours. If tolerated, two periods of 20 minutes of supine position with a reverse trendelenberg position of 15-20 degrees will be used to promote orthostasis. Level 2 is turning every 2 hours, positioning in reverse trendelenberg at 15-25 degrees as tolerated, active resistance with ICU staff for 20 minutes daily for a total of 60-80 minutes of activity/positioning daily. At Level 3, 2 times 20 minutes of a sitting are added to active ROM and inbed turning (estimated 80-100 total minutes of activity daily). Sitting is in bed or with non-weightbearing assisted transfer to chair with backrest elevation at 75-90 degrees and legs in a dependent position. Level 3 interventions; minimal weight-bearing. Level 4, weight-bearing transfer to chair and ambulation are added to inbed turning.

Sponsors & Collaborators

  • Hill-Rom

    lead INDUSTRY

Principal Investigators

  • Chris Winkelman, PhD · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-04-30
Completion
2009-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00787098 on ClinicalTrials.gov