Sepsis SyndromesNCT01364909
Exercise in Critically Ill Patients With Sepsis
A study testing Exercise and Usual practice in people with Sepsis Syndromes, run by The University of Queensland at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis Syndromes
- What is being tested?
- Exercise and Usual practice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2007to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Intervention With Exercise in Critically Ill Patients With Sepsis: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Sepsis Syndromes
- Being tested
- Exercise, Usual practice
- Keywords
- Sepsis, Severe sepsis, Septic shock, Septicaemia, Bacteremia
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Sepsis, Shock, Septic, Toxemia, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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
Usual practiceOther
These patients will not receive exercise early in their intensive care admission
| Study group | Role | What they receive |
|---|---|---|
| Control (usual practice) | Placebo comparator | Not described Receives: Other: Usual practice |
| Exercise | Experimental | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline to one week, then change from baseline to two weeks
Secondary outcomes (4)
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.
Measured: Change from baseline to measurements taken daily for 7 days
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.
Measured: Change from baseline to measurements taken daily for 7 days
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.
Measured: Change from baseline to measurements taken daily for 7 days
Vital signs - observation only
Recording of vital signs ie heart rate, ECG, blood pressure, oxygen saturation from the IntelliVue bedside monitor MP70 (Phillips)
Measured: Fifteen minutes pre and post every exercise session recorded every 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJun 2007
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brisbane and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364909
- Sponsor's protocol ID
- XSEP1
- Status last verified
- Oct 2008
- First submitted
- 27 May 2011
- Last updated
- 3 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention With Exercise in Critically Ill Patients With Sepsis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01364909
- Acronym / sponsor ID
- XSEP1
- Conditions
- Sepsis Syndromes
- Keywords
- Sepsis, Severe sepsis, Septic shock, Septicaemia, Bacteremia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Royal Brisbane and Women's Hospital
- Study start
- Jun 2007
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (usual practice) | Placebo comparator | Other: Usual practice |
| Exercise | Experimental | Other: Exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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 | Exercise |
| Usual practiceThese patients will not receive exercise early in their intensive care admission | Other | Control (usual practice) |
Primary outcome
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).
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Usual practice in people with Sepsis Syndromes, run by The University of Queensland at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat free mass ie muscle mass (lean tissue) (time frame: Change from baseline to one week, then change from baseline to two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2011; AzTrials last refreshed its copy on 31 Oct 2026.