Exercise in Critically Ill Patients With Sepsis

Not Applicable

• Conditions: Sepsis Syndromes
• Interventions: Other: Usual practice; Other: Exercise

• Registration Number: NCT01364909
• Lead Sponsor: The University of Queensland

Brief Summary

This study will investigate whether early exercise in critically ill patients will decrease inflammatory markers, increase pro-inflammatory markers and prevent loss of muscle mass.

Detailed Description

This study will investigate the effects of an early targeted rehabilitation program on inflammatory markers and muscle mass in patients with sepsis syndromes in intensive care.

The Primary Hypothesis is that an early targeted rehabilitation ICU patients with sepsis syndromes over 7 days will Prevent loss of lean muscle mass by within 7 days of recruitment to the study. Decrease pro-inflammatory and increase anti-inflammatory cytokines within 7 days of recruitment to the study.

Study Timeline

• Study Start: 2007-06
• Status Verified: 2008-10
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-02
• Last Update Submitted: 2011-06-02
• Study First Posted: 2011-06-03
• Last Update Posted: 2011-06-03
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Systemic inflammatory response syndrome with a proven or suspected infectious etiology.
• 18 years and over
• Relatives willing to give consent
• Admitted to intensive care and likely to remain ventilated for > 48 hours

Exclusion Criteria

• Patients with septic shock unresponsive to maximal treatment or who are moribund or have an expected mortality within 48 hours
• Head injuries
• Burn injury
• Multiple lower limb fractures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (usual practice)	Usual practice	-
Exercise	Exercise	-

Primary Outcome Measures

Name	Time	Method
Fat free mass ie muscle mass (lean tissue)	Change from baseline to one week, then change from baseline to two weeks	Fat free mass will be measured by Multi-Frequency Bioelectrical Impedance Spectroscopy (BIS) (ImpediMed SFB7, ImpediMed Ltd, Brisbane, Australia).

Secondary Outcome Measures

Name	Time	Method
Interleukin 6	Change from baseline to measurements taken daily for 7 days	5mls blood from arterial catheter, centrifuged at 1,500 for 10 minutes at 4 degrees C. The supernaturant will be collected and stored at -80 degrees C. The marker will be analyzed by an enzyme-linked immuno-assay.
Tumour necrosis factor alpha (TNF-alpha)	Change from baseline to measurements taken daily for 7 days	5mls blood from arterial catheter, centrifuged at 1,500 for 10 minutes at 4 degrees C. The supernaturant will be collected and stored at -80 degrees C. The marker will be analyzed by an enzyme-linked immuno-assay.
Interleukin 10	Change from baseline to measurements taken daily for 7 days	5mls blood from arterial catheter, centrifuged at 1,500 for 10 minutes at 4 degrees C. The supernaturant will be collected and stored at -80 degrees C. The marker will be analyzed by an enzyme-linked immuno-assay.
Vital signs - observation only	Fifteen minutes pre and post every exercise session recorded every 10 seconds	Recording of vital signs ie heart rate, ECG, blood pressure, oxygen saturation from the IntelliVue bedside monitor MP70 (Phillips)

Trial Locations

Locations (1)

Royal Brisbane & Womens Hospital; 🇦🇺 Brisbane, Queensland, Australia