Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
29 participants
INTERVENTIONAL
2013-02-28
2015-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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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.
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.
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.
Control Group
Routinary Passive Range of Motion will be performed by physiotherapist 20 min and twice a day until ICU discharge.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
85 Years
ALL
No
Sponsors
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Responsible Party
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Principal Investigators
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Pierre-François Laterre, Professor
Role: STUDY_CHAIR
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Locations
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Brussels, Brussels Capital, Belgium
Countries
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References
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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.
Other Identifiers
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EarlyPTProtocol1
Identifier Type: -
Identifier Source: org_study_id