Early Cycloergometric Physiotherapy in Critically Ill Patients With Invasive Mechanical Ventilation

Cycloergometric treatment is described to improve the functional and motor status of critically ill subjects. However, there are few studies comparing cycloergometric physiotherapy and conventional physiotherapy in intensive care subjects under mechanical ventilation. The most relevant of these studies conducted by Burtin et al showed beneficial effects of cycloergometric treatment. However, the duration of the physiotherapy sessions in this study differed between groups as cycloergometric group received a double daily dose of treatment. It is known that the intensity of physiotherapy also affects the functional and motor status.

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.

• Cycle ergometer physiotherapy (Procedure), also known as MOTOmed ® Letto 2: 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 (Procedure): 30 minutes of conventional physiotherapy

Primary outcomes

• Walking test distance at six minutes [At hospital discharge, with an expected average of 4 weeks after hospital admission]
• Short Form-36 Health Survey (SF-36), physical functioning section [At 28 days after hospital discharge, that is an expected average of 8 weeks]
• Basic activities of daily living score (BADL) [At 28 days after hospital discharge, that is an expected average of 8 weeks]

Secondary outcomes

• Lung Functional Testing [At the end of hospital stay, with an expected average of 5 weeks]
• Presence of intensive care acquired paresis (Medical Research Council score < 48 points) [During ICU admission and ICU discharge, with an expected average of 2 weeks]
• ICU mobilization scale [During hospital stay, as expected average of 4 weeks, and at 28 days and at 6 months after discharge]
• Isometric quadriceps force (N/kg) [During ICU admission, with an expected average of 2 weeks]: Quadriceps strength will be measured with a handheld dynamometer with patients in supine position and 30º of knee flexion.
• Walking test distance at six minutes [At 28 days and at 6 months after hospital discharge, that is up to 1 year]
• Short Form-36 Health Survey (SF-36), physical functioning section [At 7 days and at 6 months after hospital discharge, that is up to 1 year]
• Basic activities of daily living score (BADL) [At 7 days and at 6 months after hospital discharge, that is up to 1 year]

Other outcomes

• Changes in Pulse Oximeter Oxygen Saturation (SpO2) between end and initial values after physiotherapy sessions [ICU admission, with an expected average of 2 weeks]
• Change in respiratory rate between end and initial values after physiotherapy sessions [ICU admission, with an expected average of 2 weeks]: Respiratory rate
• Change in heart rate between end and initial values after physiotherapy sessions [ICU admission, with an expected average of 2 weeks]
• Change in mean blood pressure between end and initial values after physiotherapy sessions [ICU admission, with an expected average of 2 weeks]

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Criteria of functional independence before hospital admission (Barthel scale > 70 points).
* Invasive mechanical ventilation < 72 hours.
* Signed informed consent.

Exclusion Criteria:

* Neuromuscular disease (peripheric or central neurologic disorder).
* 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.

• Results publication: 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. PMID 12472328
• Results publication: 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. PMID 25715872
• Results publication: 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. PMID 22147819
• Results publication: 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. PMID 19446324
• Results publication: 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. PMID 20046132
• Results publication: 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. PMID 19623052
• Results publication: 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. PMID 20406506

• Gemma Rialp, M.D., Principal investigator, IDISPA