Weakness
Conditions
Keywords
muscle weakness, rehabilitation, intensive care, mechanical ventilation, cyclo ergometer, physiotherapy
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.
Interventions
PROCEDURECycle 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
PROCEDUREConventional physiotherapy
30 minutes of conventional physiotherapy
Sponsors
Hospital Son Llatzer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Walking test distance at six minutes | At hospital discharge, with an expected average of 4 weeks after hospital admission |
| Basic activities of daily living score (BADL) | At 28 days after hospital discharge, that is an expected average of 8 weeks |
| Short Form-36 Health Survey (SF-36), physical functioning section | At 28 days after hospital discharge, that is an expected average of 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 | — |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in respiratory rate between end and initial values after physiotherapy sessions | ICU admission, with an expected average of 2 weeks | Respiratory rate |
| 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 mean blood pressure between end and initial values after physiotherapy sessions | ICU admission, with an expected average of 2 weeks | — |
| Change in heart rate between end and initial values after physiotherapy sessions | ICU admission, with an expected average of 2 weeks | — |
Countries
Spain
Contacts
Primary ContactGemma Rialp, M.D.
Backup ContactCatalina Morey, Phyt
Outcome results
None listed