Early Cycloergometric Physiotherapy in Critically Ill Patients With Invasive Mechanical Ventilation
NCT ID: NCT02478411
Last Updated: 2019-08-08
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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UNKNOWN
NA
68 participants
INTERVENTIONAL
2015-06-30
2021-06-30
Brief Summary
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Detailed Description
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For this reason, the investigators designed a randomized controlled study with early cycloergometric or conventional treatment, with the same intensity between groups to analyze objective functional and motor endpoints.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cycle ergometer physiotherapy
15 minutes of cycle ergometer physiotherapy plus 15 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit
Cycle ergometer physiotherapy
15 minutes of cyclo ergometer physiotherapy with MOTOmed ® Letto 2 device with passive, motor-assisted and active-resisted exercise of the lower and upper extremity, and 15 minutes of conventional physiotherapy
Conventional physiotherapy
30 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit
Conventional physiotherapy
30 minutes of conventional physiotherapy
Interventions
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Cycle ergometer physiotherapy
15 minutes of cyclo ergometer physiotherapy with MOTOmed ® Letto 2 device with passive, motor-assisted and active-resisted exercise of the lower and upper extremity, and 15 minutes of conventional physiotherapy
Conventional physiotherapy
30 minutes of conventional physiotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Invasive mechanical ventilation \< 72 hours.
* Signed informed consent.
Exclusion Criteria
* Presumed fatal evolution in 48 hours.
* Conditions that impede pedaling movement (leg, pelvis or lumbar spinal surgery or traumatism).
* Admission due to cardiac arrest.
* Pregnancy.
* Thrombopenia less than 50.000.
* Severe agitation.
* Hemodynamic instability with noradrenaline requirements greater than 1 mcg/kg/min.
* Fraction of inspired Oxygen (FiO2) requirements greater that 0.55 and respiratory rate greater than 30 bpm.
18 Years
ALL
No
Sponsors
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Hospital Son Llatzer
OTHER
Responsible Party
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Gemma Rialp
M.D.
Principal Investigators
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Gemma Rialp, M.D.
Role: PRINCIPAL_INVESTIGATOR
IDISPA
Locations
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Hospital Son llàtzer
Palma de Mallorca, Balearic Islands, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.
TEAM Study Investigators; Hodgson C, Bellomo R, Berney S, Bailey M, Buhr H, Denehy L, Harrold M, Higgins A, Presneill J, Saxena M, Skinner E, Young P, Webb S. Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study. Crit Care. 2015 Feb 26;19(1):81. doi: 10.1186/s13054-015-0765-4.
Schweickert WD, Kress JP. Implementing early mobilization interventions in mechanically ventilated patients in the ICU. Chest. 2011 Dec;140(6):1612-1617. doi: 10.1378/chest.10-2829.
Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.
Needham DM, Truong AD, Fan E. Technology to enhance physical rehabilitation of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S436-41. doi: 10.1097/CCM.0b013e3181b6fa29.
Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937.
Bourdin G, Barbier J, Burle JF, Durante G, Passant S, Vincent B, Badet M, Bayle F, Richard JC, Guerin C. The feasibility of early physical activity in intensive care unit patients: a prospective observational one-center study. Respir Care. 2010 Apr;55(4):400-7.
Other Identifiers
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CYCLE-ICU-001
Identifier Type: -
Identifier Source: org_study_id
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