Early Cycloergometric Physiotherapy in Critically Ill Patients With Invasive Mechanical Ventilation

NCT02478411 | Unknown

• 1 other identifier: CYCLE-ICU-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Weakness

Keywords

muscle weakness; rehabilitation; intensive care; mechanical ventilation; cyclo ergometer; physiotherapy

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• 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

• 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

• Walking test distance at six minutes

  At 28 days and at 6 months after hospital discharge, that is up to 1 year

Other Outcomes (4)

• 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

  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

Study Arms (2)

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

Procedure: Cycle ergometer physiotherapy

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

Procedure: Conventional physiotherapy

Interventions

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

Also known as: MOTOmed ® Letto 2

Cycle ergometer physiotherapy

Conventional physiotherapy PROCEDURE

30 minutes of conventional physiotherapy

Conventional physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Criteria of functional independence before hospital admission (Barthel scale \> 70 points).
• Invasive mechanical ventilation \< 72 hours.
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Son Llatzer: lead

Study Sites (1)

Hospital Son llàtzer

Palma de Mallorca, Balearic Islands, 07198, Spain

RECRUITING

Related Publications (7)

• 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.

  PMID: 12472328 RESULT

• 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.

  PMID: 25715872 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.

  PMID: 22147819 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.

  PMID: 19446324 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.

  PMID: 20046132 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.

  PMID: 19623052 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.

  PMID: 20406506 RESULT

MeSH Terms

Conditions

Asthenia; Muscle Weakness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes

Study Officials

• Gemma Rialp, M.D.

  IDISPA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gemma Rialp, M.D.

CONTACT

00 34 871202133; grialp@gmail.com

Catalina Morey, Phyt

CONTACT

cati.cmf@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 14, 2015
• First Posted: June 23, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: August 8, 2019

Record last verified: 2019-08

Locations

ES (1)