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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cycle ergometer physiotherapy | Experimental | 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 |
|
| Conventional physiotherapy | Active Comparator | 30 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cycle ergometer physiotherapy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Respiratory rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gemma Rialp, M.D. | Contact | 00 34 871202133 | grialp@gmail.com | |
| Catalina Morey, Phyt | Contact | cati.cmf@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gemma Rialp, M.D. | IDISPA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Son llàtzer | Recruiting | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12472328 | Result | 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. | |
| 25715872 |
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| ID | Term |
|---|---|
| D001247 | Asthenia |
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Conventional physiotherapy | Procedure | 30 minutes of conventional physiotherapy |
|
| 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) | Quadriceps strength will be measured with a handheld dynamometer with patients in supine position and 30º of knee flexion. | During ICU admission, 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 |
| 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 |
| Change in mean blood pressure between end and initial values after physiotherapy sessions | ICU admission, with an expected average of 2 weeks |
| 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. |
| 22147819 | Result | 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. |
| 19446324 | Result | 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. |
| 20046132 | Result | 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. |
| 19623052 | Result | 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. |
| 20406506 | Result | 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. |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |