Early Cycloergometric Physiotherapy in Critically Ill Patients With Invasive Mechanical Ventilation

Weakness Clinical Trial

Official title:

Functional and Motor Effects of an Early Cycloergometric Physiotherapy Program in Critically Ill Patients With Invasive Mechanical Ventilation. A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02478411
• Other study ID #: CYCLE-ICU-001
• Status: Recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: June 2021

Study information

• Verified date: August 2019
• Source: Hospital Son Llatzer
• Contact: Gemma Rialp, M.D.
• Phone: 00 34 871202133
• Email: grialp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Weakness

Intervention

Procedure:
• Cycle 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
• Conventional physiotherapy
30 minutes of conventional physiotherapy

Locations

Country	Name	City	State
Spain	Hospital Son llàtzer	Palma de Mallorca	Illes Balears

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Son Llatzer

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Bourdin G, Barbier J, Burle JF, Durante G, Passant S, Vincent B, Badet M, Bayle F, Richard JC, Guérin C. The feasibility of early physical activity in intensive care unit patients: a prospective observational one-center study. Respir Care. 2010 Apr;55(4): — View 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.0b013e318 — View Citation

De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphaël JC, Outin H, Bastuji-Garin S; Groupe de Réflexion et d'Etude des Neuromyopathies en Réanimation. Paresis acquired in the int — View 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. Review. — View 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. Review. — View 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, critic — View 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, m — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Pulse Oximeter Oxygen Saturation (SpO2) between end and initial values after physiotherapy sessions		ICU admission, with an expected average of 2 weeks
Other	Change in respiratory rate between end and initial values after physiotherapy sessions	Respiratory rate	ICU admission, with an expected average of 2 weeks
Other	Change in heart rate between end and initial values after physiotherapy sessions		ICU admission, with an expected average of 2 weeks
Other	Change in mean blood pressure between end and initial values after physiotherapy sessions		ICU admission, with an expected average of 2 weeks
Primary	Walking test distance at six minutes		At hospital discharge, with an expected average of 4 weeks after hospital admission
Primary	Short Form-36 Health Survey (SF-36), physical functioning section		At 28 days after hospital discharge, that is an expected average of 8 weeks
Primary	Basic activities of daily living score (BADL)		At 28 days after hospital discharge, that is an expected average of 8 weeks
Secondary	Lung Functional Testing		At the end of hospital stay, with an expected average of 5 weeks
Secondary	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
Secondary	ICU mobilization scale		During hospital stay, as expected average of 4 weeks, and at 28 days and at 6 months after discharge
Secondary	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
Secondary	Walking test distance at six minutes		At 28 days and at 6 months after hospital discharge, that is up to 1 year
Secondary	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
Secondary	Basic activities of daily living score (BADL)		At 7 days and at 6 months after hospital discharge, that is up to 1 year