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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
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
30 minutes of conventional physiotherapy
Hospital Son llàtzer
Palma de Mallorca, Balearic Islands, Spain
RECRUITINGWalking test distance at six minutes
Time frame: At hospital discharge, with an expected average of 4 weeks after hospital admission
Short Form-36 Health Survey (SF-36), physical functioning section
Time frame: At 28 days after hospital discharge, that is an expected average of 8 weeks
Basic activities of daily living score (BADL)
Time frame: At 28 days after hospital discharge, that is an expected average of 8 weeks
Lung Functional Testing
Time frame: 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)
Time frame: During ICU admission and ICU discharge, with an expected average of 2 weeks
ICU mobilization scale
Time frame: During hospital stay, as expected average of 4 weeks, and at 28 days and at 6 months after discharge
Isometric quadriceps force (N/kg)
Quadriceps strength will be measured with a handheld dynamometer with patients in supine position and 30º of knee flexion.
Time frame: During ICU admission, with an expected average of 2 weeks
Walking test distance at six minutes
Time frame: 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
Time frame: At 7 days and at 6 months after hospital discharge, that is up to 1 year
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Basic activities of daily living score (BADL)
Time frame: At 7 days and at 6 months after hospital discharge, that is up to 1 year