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

NCT01707303 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-08-15

No results posted yet for this study

Summary

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.

Conditions

  • Acute Respiratory Failure

Interventions

OTHER

Early ICU rehabilitation strategies

Physical therapy - standard; Physical therapy, progressive resistance training for 2nd physical therapy session in Cohort II

OTHER

Usual Care

All typically applied hospital rehabilitative services applied in the usual fashion

Sponsors & Collaborators

  • Wake Forest University

    lead OTHER

Principal Investigators

  • Peter E. Morris, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-07-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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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 NCT01707303 on ClinicalTrials.gov