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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01707303

Enrollment

100

Registered

2012-10-16

Start date

2007-07-31

Completion date

2009-08-31

Last updated

2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

ICU, Critical Care, Intensive Care, Critical Illness, Acute Respiratory Failure, Mechanical Ventilation, Physical Therapy, Strength, Functional Status, Short Physical Performance Battery

Brief 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.

Interventions

OTHEREarly ICU rehabilitation strategies

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

OTHERUsual Care

All typically applied hospital rehabilitative services applied in the usual fashion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Hospital length of stay, days	The participants will be followed for the duration of the hospitalization, an expected average of 3 weeks.	Hospital stay measured in days.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026