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Early Physical Therapy in Patients With Sepsis (EARTH-ICU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01787045
Recruitment Status : Terminated
First Posted : February 8, 2013
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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. 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.


Condition or disease Intervention/treatment Phase
SEPTIC SHOCK SEPSIS SYNDROME Multiple Organ Dysfunction Syndrome Other: Early and Active Physical Therapy Other: Passive Range of Motion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Early Physical Activity on Skeletal Muscle Signaling Pathways Controlling Protein Turnover in Patients With Sepsis.
Study Start Date : February 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group

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.

Other: Early and Active Physical Therapy

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.

Other Names:
  • Early Physical Rehabilitation
  • Early Physical Training
  • Early Physiotherapy
  • Early Mobilization
  • Very Early Mobilisation
  • Early Exercise
  • Early Activity
  • Early Mobility Therapy

Other: 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.
Other Names:
  • Passive Range of Motion (PROM)
  • Passive Mobilization
  • Articular mobilization
  • Routinary Passive Range of Motion
  • Usual manual mobilization

Control Group
Routinary Passive Range of Motion will be performed by physiotherapist 20 min and twice a day until ICU discharge.
Other: 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.
Other Names:
  • Passive Range of Motion (PROM)
  • Passive Mobilization
  • Articular mobilization
  • Routinary Passive Range of Motion
  • Usual manual mobilization




Primary Outcome Measures :
  1. Change in activation of skeletal muscle synthetic and catabolic pathways. [ Time Frame: Within the first 7 days (plus or minus 1 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787045


Locations
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Belgium
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Study Chair: Pierre-François Laterre, Professor Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01787045    
Other Study ID Numbers: EarlyPTProtocol1
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
SEPSIS
Additional relevant MeSH terms:
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Sepsis
Toxemia
Syndrome
Multiple Organ Failure
Systemic Inflammatory Response Syndrome
Disease
Pathologic Processes
Infections
Inflammation
Shock