NCT01707303

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Wake Forest University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-07-01
• Completion: 2009-08-01
• First posted: 2012-10-16
• Last updated: 2018-08-15

Locations

1 site across 1 country: United States