Clinical trial NCT02478411: Early Cycloergometric Physiotherapy in Critically Ill Patients With Invasive Mechanical Ventilation
Official title: Functional and Motor Effects of an Early Cycloergometric Physiotherapy Program in Critically Ill Patients With Invasive Mechanical Ventilation. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weakness
Keywords: muscle weakness
rehabilitation
intensive care
mechanical ventilation
cyclo ergometer
physiotherapy
Lead sponsor: Hospital Son Llatzer
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study designed to evaluate the functional and motor effects in critically ill subjects at ICU and hospital discharge with the incorporation of a mobilization program of cycloergometric physiotherapy sessions compared with conventional physiotherapy.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Walking test distance at six minutes
timeFrame: At hospital discharge, with an expected average of 4 weeks after hospital admission
measure: Short Form-36 Health Survey (SF-36), physical functioning section
timeFrame: At 28 days after hospital discharge, that is an expected average of 8 weeks
measure: Basic activities of daily living score (BADL)
timeFrame: At 28 days after hospital discharge, that is an expected average of 8 weeks
Secondary outcomes:
measure: Lung Functional Testing
timeFrame: At the end of hospital stay, with an expected average of 5 weeks
measure: Presence of intensive care acquired paresis (Medical Research Council score < 48 points)
timeFrame: During ICU admission and ICU discharge, with an expected average of 2 weeks
measure: ICU mobilization scale
timeFrame: During hospital stay, as expected average of 4 weeks, and at 28 days and at 6 months after discharge
measure: Isometric quadriceps force (N/kg)
timeFrame: During ICU admission, with an expected average of 2 weeks
measure: Walking test distance at six minutes
timeFrame: At 28 days and at 6 months after hospital discharge, that is up to 1 year
measure: Short Form-36 Health Survey (SF-36), physical functioning section
timeFrame: At 7 days and at 6 months after hospital discharge, that is up to 1 year
measure: Basic activities of daily living score (BADL)
timeFrame: At 7 days and at 6 months after hospital discharge, that is up to 1 year
Other outcomes:
measure: Changes in Pulse Oximeter Oxygen Saturation (SpO2) between end and initial values after physiotherapy sessions
timeFrame: ICU admission, with an expected average of 2 weeks
measure: Change in respiratory rate between end and initial values after physiotherapy sessions
timeFrame: ICU admission, with an expected average of 2 weeks
measure: Change in heart rate between end and initial values after physiotherapy sessions
timeFrame: ICU admission, with an expected average of 2 weeks
measure: Change in mean blood pressure between end and initial values after physiotherapy sessions
timeFrame: ICU admission, with an expected average of 2 weeks
Locations:
city: Palma de Mallorca
country: Spain
facility: Hospital Son llàtzer
state: Illes Balears
Study officials:
affiliation: IDISPA
name: Gemma Rialp, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.