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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01364909




Registration number
NCT01364909
Ethics application status
Date submitted
27/05/2011
Date registered
3/06/2011
Date last updated
3/06/2011

Titles & IDs
Public title
Exercise in Critically Ill Patients With Sepsis
Scientific title
Early Intervention With Exercise in Critically Ill Patients With Sepsis: a Randomized Controlled Trial
Secondary ID [1] 0 0
XSEP1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis Syndromes 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Injuries and Accidents 0 0 0 0
Poisoning
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Exercise
Other interventions - Usual practice

Placebo Comparator: Control (usual practice) -

Experimental: Exercise -


Other interventions: 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

Other interventions: Usual practice
These patients will not receive exercise early in their intensive care admission

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fat free mass ie muscle mass (lean tissue) - Fat free mass will be measured by Multi-Frequency Bioelectrical Impedance Spectroscopy (BIS) (ImpediMed SFB7, ImpediMed Ltd, Brisbane, Australia).
Timepoint [1] 0 0
Change from baseline to one week, then change from baseline to two weeks
Secondary outcome [1] 0 0
Interleukin 6 - 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.
Timepoint [1] 0 0
Change from baseline to measurements taken daily for 7 days
Secondary outcome [2] 0 0
Tumour necrosis factor alpha (TNF-alpha) - 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.
Timepoint [2] 0 0
Change from baseline to measurements taken daily for 7 days
Secondary outcome [3] 0 0
Interleukin 10 - 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.
Timepoint [3] 0 0
Change from baseline to measurements taken daily for 7 days
Secondary outcome [4] 0 0
Vital signs - observation only - Recording of vital signs ie heart rate, ECG, blood pressure, oxygen saturation from the IntelliVue bedside monitor MP70 (Phillips)
Timepoint [4] 0 0
Fifteen minutes pre and post every exercise session recorded every 10 seconds

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane & Womens Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Brisbane and Women's Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01364909
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01364909