Overview

This trial is active, not recruiting.

Condition sepsis syndromes
Treatments exercise, usual practice
Sponsor The University of Queensland
Collaborator Royal Brisbane and Women's Hospital
Start date June 2007
End date December 2011
Trial size 40 participants
Trial identifier NCT01364909, XSEP1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
usual practice
These patients will not receive exercise early in their intensive care admission
(Experimental)
exercise
The subjects will be given 2 x 30 minute sessions of exercise per day consisting of either passive, active, active assisted depending on level of sedation and stability of condition. According to level of sedation and stability they may also perform sitting exercises

Primary Outcomes

Measure
Fat free mass ie muscle mass (lean tissue)
time frame: Change from baseline to one week, then change from baseline to two weeks

Secondary Outcomes

Measure
Interleukin 6
time frame: Change from baseline to measurements taken daily for 7 days
Tumour necrosis factor alpha (TNF-alpha)
time frame: Change from baseline to measurements taken daily for 7 days
Interleukin 10
time frame: Change from baseline to measurements taken daily for 7 days
Vital signs - observation only
time frame: Fifteen minutes pre and post every exercise session recorded every 10 seconds

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Early Intervention With Exercise in Critically Ill Patients With Sepsis: a Randomized Controlled Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by The University of Queensland.