Early Intervention With Exercise in Critically Ill Patients With Sepsis: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis Syndromes
- Sponsor
- The University of Queensland
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Fat free mass ie muscle mass (lean tissue)
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Fat free mass ie muscle mass (lean tissue)
Time Frame: 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 Outcomes
- Interleukin 6(Change from baseline to measurements taken daily for 7 days)
- Tumour necrosis factor alpha (TNF-alpha)(Change from baseline to measurements taken daily for 7 days)
- Interleukin 10(Change from baseline to measurements taken daily for 7 days)
- Vital signs - observation only(Fifteen minutes pre and post every exercise session recorded every 10 seconds)