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Effect Of Acute Inflammatory Mediators On Functional Limitations In Patients With Acute Respiratory Failure

This study has been completed.
Information provided by (Responsible Party):
Peter E. Morris, Wake Forest University Health Sciences Identifier:
First received: October 10, 2012
Last updated: January 23, 2017
Last verified: January 2017
This is a randomized, controlled, pilot study of two separate Cohorts of patients from the intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical therapy session per day or receive usual ICU care. Cohort II, will enroll an additional 50 patients and randomize to receive either two physical therapy sessions per day or usual care. Outcome will be length of hospital stay measured in days. Secondary outcomes will be mortality, ventilator days, ICU days, and for Cohort II, grip strength, dynamometer strength assessments and the short physical performance battery (SPPB). Study subjects will have blood for cytokine analysis through their first week of study.

Condition Intervention Phase
Acute Respiratory Failure
Other: Early ICU rehabilitation strategies
Other: Usual Care
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Effect Of Acute Inflammatory Mediators On Duration Of Functional Limitations In Patients With Acute Respiratory Failure, A Randomized, Controlled Pilot Study of Early ICU Rehabilitation Strategies

Resource links provided by NLM:

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Hospital length of stay, days [ Time Frame: The participants will be followed for the duration of the hospitalization, an expected average of 3 weeks. ]
    Hospital stay measured in days.

Enrollment: 100
Study Start Date: July 2007
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Usual Care
Usual hospital rehabilitative services
Other: Usual Care
All typically applied hospital rehabilitative services applied in the usual fashion
Other Name: Usual Hospital Rehabilitative Services
Experimental: Early ICU Rehabilitation Strategy
Early ICU physical therapy will be applied in this arm
Other: Early ICU rehabilitation strategies
Physical therapy - standard; Physical therapy, progressive resistance training for 2nd physical therapy session in Cohort II
Other Name: Cohort I will receive one physical therapy session per day; Cohort II will receive 2 physical therapy sessions per day.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

• Mechanically ventilated via an endotracheal tube or mask

Exclusion Criteria:

  • Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not exclusions)
  • Cognitive impairment prior to acute ICU illness (non-verbal)
  • Preadmit immunocompromised (>prednisone 20 mg/d for 2 wks)
  • Acute stroke
  • Body mass index (BMI) >45
  • Neuromuscular disease that could impair weaning (myasthenia gravis, ALS, Guillain-Barre)
  • Hip fracture, unstable cervical spine or pathological fracture
  • Mech vent >48 hours prior to transfer from an outside facility
  • Current hospitalization or transferring hospital stay >72 hours
  • CPR on admission, DNR on admission
  • Hospitalization within 30 days prior to admission
  • Cancer therapy within last 6 months
  • Re-admission to ICU within current hospitalization
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Please refer to this study by its identifier: NCT01707303

United States, North Carolina
Wake Forest School of Medicine
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Principal Investigator: Peter E. Morris, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Peter E. Morris, Professor, Wake Forest University Health Sciences Identifier: NCT01707303     History of Changes
Other Study ID Numbers: IRB00000240
Study First Received: October 10, 2012
Last Updated: January 23, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Wake Forest University Health Sciences:
Critical Care
Intensive Care
Critical Illness
Acute Respiratory Failure
Mechanical Ventilation
Physical Therapy
Functional Status
Short Physical Performance Battery

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases processed this record on April 26, 2017