SEPTIC SHOCKEARTH-ICUNCT01787045
Early Physical Therapy in Patients With Sepsis
A study testing Early and Active Physical Therapy and Passive Range of Motion in people with SEPTIC SHOCK and SEPSIS SYNDROME, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
It is clearly shown that patients in the Intensive care Unit (ICU) with severe sepsis or multi organic failure are very susceptible to develop neuromuscular complications. That can be attributed to a hyper catabolic state, general inflammation and immobilization. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- SEPTIC SHOCK, SEPSIS SYNDROME, Multiple Organ Dysfunction Syndrome
- What is being tested?
- Early and Active Physical Therapy and Passive Range of Motion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2013to Nov 2015
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodynamically stable patients.
- Admitted to ICU for sepsis or MOF (multiple organ failure) or who developing during their ICU stay within the first 24 hours of the ICU admission.
- With an expected ICU stay of at least 7 days.
Who cannot join
- Patients without approved consent.
- Patients with a known neuromuscular disorder before ICU admission.
- Moribund patients.
- Severe metabolic/hemodynamic instability despite pharmacological support.
- Having conditions that impair evaluation techniques or intervention methods.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Brussels, Brussels Capital, 1200
About this study
Official title: Effect of Early Physical Activity on Skeletal Muscle Signaling Pathways Controlling Protein Turnover in Patients With Sepsis.
It is clearly shown that patients in the Intensive care Unit (ICU) with severe sepsis or multi organic failure are very susceptible to develop neuromuscular complications. That can be attributed to a hyper catabolic state, general inflammation and immobilization. This can leads a significant muscle wasting, polyneuropathy and/or myopathy. These alterations have been defined with the term Intensive Care Acquired Weakness (ICUAW) and can leads important functional squeals and impaired quality of life for months, years and in some cases irreversibly.
To overcome these complications, early activation by physiotherapy becomes an important tool. This type of treatment has been show to be feasible, safe and improves the functional capacity of patients. In addition to a reduction in the duration of ICU and hospital stay and improved quality of life for patients.
Read more
The objective of this study is to demonstrate that the early and active physical activity in patients with severe sepsis can limit the loss of muscle mass and complications related to this type of damage.
Procedures: Patients or relatives will be asked to participate in the study. If a positive response is done, patients will be randomized in an intervention or control group.
A baseline evaluation will be performed during the first day of study admission. That includes a physical exploration, electrophysiological studies, skeletal muscle histological/biochemical evaluations and monitoring of blood biomarkers and others clinical outcomes will be registered.
Intervention will be divided in a morning and afternoon times, patient will be positioned in chair or bed and mobilized by physiotherapist. As usual, all patients will be attaining manual mobilization for 20 minutes twice a day. Only for intervention group, additional cycle-ergometer exercise will be performed for 30 minutes at better performance achieved and tolerated for patient. All vitals parameters will be strictly controlled before, during and after intervention.
The same baseline evaluation will be repeated after day 7 and clinical outcomes will be registered until ICU discharge.
- Being tested
- Early and Active Physical Therapy, Passive Range of Motion
- Keywords
- SEPSIS
- Medical subject headings
- Shock, Septic, Systemic Inflammatory Response Syndrome, Multiple Organ Failure, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early and Active Physical TherapyOther
Also called Early Physical Rehabilitation, Early Physical Training, Early Physiotherapy, Early Mobilization
Cycle-ergometer exercise will be performed in the more active manner tolerated by patient. Potency attained will be registered during 30 min of exercise.
Our physiotherapy protocol includes also others exercises like ambulation with assistance, cycle-ergometer for arms and legs, etc.
Passive Range of MotionOther
Also called Passive Range of Motion (PROM), Passive Mobilization, Articular mobilization, Routinary Passive Range of Motion
Passive mobilization will be performed in all limbs as 10 repetitions of every range of motions. Extension position will be maintained for some seconds to attaint muscular elongation in every muscular group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Early and Active Physical Therapy will be performed by physiotherapist twice a day. During first week patients will be positioned in chair or bed and performed cycle-ergometer exercise during 30 min.
Our physiotherapy protocol will be continued until Intensive Care Unit (ICU) discharge. Receives: Other: Early and Active Physical Therapy; Other: Passive Range of Motion |
| Control Group | Other | Routinary Passive Range of Motion will be performed by physiotherapist 20 min and twice a day until ICU discharge. Receives: Other: Passive Range of Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in activation of skeletal muscle synthetic and catabolic pathways.
Measured: Within the first 7 days (plus or minus 1 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SEPTIC SHOCKStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-François Laterre, Professor, Study chair, Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787045
- Sponsor's protocol ID
- EarlyPTProtocol1
- Acronym
- EARTH-ICU
- Status last verified
- Nov 2015
- First submitted
- 6 Feb 2013
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hickmann CE, Castanares-Zapatero D, Deldicque L, Van den Bergh P, Caty G, Robert A, Roeseler J, Francaux M, Laterre PF. Impact of Very Early Physical Therapy During Septic Shock on Skeletal Muscle: A Randomized Controlled Trial. Crit Care Med. 2018 Sep;46(9):1436-1443. doi: 10.1097/CCM.0000000000003263.
PubMed 29957714
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Physical Activity on Skeletal Muscle Signaling Pathways Controlling Protein Turnover in Patients With Sepsis.
- ClinicalTrials.gov ID
- NCT01787045
- Acronym / sponsor ID
- EARTH-ICU / EarlyPTProtocol1
- Keywords
- SEPSIS
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 8 Feb 2013 (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.
It is clearly shown that patients in the Intensive care Unit (ICU) with severe sepsis or multi organic failure are very susceptible to develop neuromuscular complications. That can be attributed to a hyper catabolic state, general inflammation and immobilization. This can leads a significant muscle wasting, polyneuropathy and/or myopathy. These alterations have been defined with the term Intensive Care Acquired Weakness (ICUAW) and can leads important functional squeals and impaired quality of life for months, years and in some cases irreversibly.
To overcome these complications, early activation by physiotherapy becomes an important tool. This type of treatment has been show to be feasible, safe and improves the functional capacity of patients. In addition to a reduction in the duration of ICU and hospital stay and improved quality of life for patients.
The objective of this study is to demonstrate that the early and active physical activity in patients with severe sepsis can limit the loss of muscle mass and complications related to this type of damage.
Procedures: Patients or relatives will be asked to participate in the study. If a positive response is done, patients will be randomized in an intervention or control group.
A baseline evaluation will be performed during the first day of study admission. That includes a physical exploration, electrophysiological studies, skeletal muscle histological/biochemical evaluations and monitoring of blood biomarkers and others clinical outcomes will be registered.
Intervention will be divided in a morning and afternoon times, patient will be positioned in chair or bed and mobilized by physiotherapist. As usual, all patients will be attaining manual mobilization for 20 minutes twice a day. Only for intervention group, additional cycle-ergometer exercise will be performed for 30 minutes at better performance achieved and tolerated for patient. All vitals parameters will be strictly controlled before, during and after intervention.
The same baseline evaluation will be repeated after day 7 and clinical outcomes will be registered until ICU discharge.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Early and Active Physical Therapy, Other: Passive Range of MotionEarly and Active Physical Therapy will be performed by physiotherapist twice a day. During first week patients will be positioned in chair or bed and performed cycle-ergometer exercise during 30 min. Our physiotherapy protocol will be continued until Intensive Care Unit (ICU) discharge. |
| Control Group | Other | Other: Passive Range of MotionRoutinary Passive Range of Motion will be performed by physiotherapist 20 min and twice a day until ICU discharge. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hemodynamically stable patients.
- Admitted to ICU for sepsis or MOF (multiple organ failure) or who developing during their ICU stay within the first 24 hours of the ICU admission.
- With an expected ICU stay of at least 7 days.
Key exclusion criteria (5 listed)
- Patients without approved consent.
- Patients with a known neuromuscular disorder before ICU admission.
- Moribund patients.
- Severe metabolic/hemodynamic instability despite pharmacological support.
- Having conditions that impair evaluation techniques or intervention methods.
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 |
|---|---|---|
| Early and Active Physical TherapyAlso: Early Physical Rehabilitation, Early Physical Training, Early Physiotherapy, Early MobilizationCycle-ergometer exercise will be performed in the more active manner tolerated by patient. Potency attained will be registered during 30 min of exercise. Our physiotherapy protocol includes also others exercises like ambulation with assistance, cycle-ergometer for arms and legs, etc. | Other | Intervention Group |
| Passive Range of MotionAlso: Passive Range of Motion (PROM), Passive Mobilization, Articular mobilization, Routinary Passive Range of MotionPassive mobilization will be performed in all limbs as 10 repetitions of every range of motions. Extension position will be maintained for some seconds to attaint muscular elongation in every muscular group. | Other | Control Group, Intervention Group |
Primary outcome
Change in activation of skeletal muscle synthetic and catabolic pathways.
Time frame: Within the first 7 days (plus or minus 1 days)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
- Derived from this study: PubMed 29957714Hickmann CE, Castanares-Zapatero D, Deldicque L, Van den Bergh P, Caty G, Robert A, Roeseler J, Francaux M, Laterre PF. Impact of Very Early Physical Therapy During Septic Shock on Skeletal Muscle: A Randomized Controlled Trial. Crit Care Med. 2018 Sep;46(9):1436-1443. doi: 10.1097/CCM.0000000000003263.
Related trials for SEPTIC SHOCK
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
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Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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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.
Pierre-François Laterre, Professor study chair
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early and Active Physical Therapy and Passive Range of Motion in people with SEPTIC SHOCK and SEPSIS SYNDROME, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 17 Nov 2015. 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 Belgium. 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. 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?
The study was stopped early. 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?
Change in activation of skeletal muscle synthetic and catabolic pathways. (time frame: Within the first 7 days (plus or minus 1 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01787045, which also lists 1 linked publication.
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 17 Nov 2015.