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

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.

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Key information

Conditions

Acute Respiratory Failure Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early ICU rehabilitation strategies

Other

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

Other names: Cohort I will receive one physical therapy session per day; Cohort II will receive 2 physical therapy sessions per day.

Usual Care

Other

All typically applied hospital rehabilitative services applied in the usual fashion

Other names: Usual Hospital Rehabilitative Services

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Oct 16, 2012
Registry last updated: Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed