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Early Cycloergometric Physiotherapy in Critically Ill Patients With Invasive Mechanical Ventilation

Primary Purpose

Weakness

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Cycle ergometer physiotherapy

Conventional physiotherapy

About this trial

This is an interventional treatment trial for Weakness focused on measuring muscle weakness, rehabilitation, intensive care, mechanical ventilation, cyclo ergometer, physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Son llàtzerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cycle ergometer physiotherapy

Conventional physiotherapy

Arm Description

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

30 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit

Outcomes

Primary Outcome Measures

Walking test distance at six minutes

Short Form-36 Health Survey (SF-36), physical functioning section

Basic activities of daily living score (BADL)

Secondary Outcome Measures

Lung Functional Testing

Presence of intensive care acquired paresis (Medical Research Council score < 48 points)

ICU mobilization scale

Isometric quadriceps force (N/kg)

Quadriceps strength will be measured with a handheld dynamometer with patients in supine position and 30º of knee flexion.

Walking test distance at six minutes

Short Form-36 Health Survey (SF-36), physical functioning section

Basic activities of daily living score (BADL)

Full Information

NCT ID

NCT02478411

First Posted

June 14, 2015

Last Updated

August 6, 2019

Sponsor

Hospital Son Llatzer

1. Study Identification

Unique Protocol Identification Number

NCT02478411

Brief Title

Early Cycloergometric Physiotherapy in Critically Ill Patients With Invasive Mechanical Ventilation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 2015 (undefined)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Son Llatzer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weakness

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cycle ergometer physiotherapy

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional physiotherapy

Arm Type

Active Comparator

Arm Description

30 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit

Intervention Type

Procedure

Intervention Name(s)

Cycle ergometer physiotherapy

Other Intervention Name(s)

MOTOmed ® Letto 2

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Conventional physiotherapy

Intervention Description

30 minutes of conventional physiotherapy

Primary Outcome Measure Information:

Title

Walking test distance at six minutes

Time Frame

At hospital discharge, with an expected average of 4 weeks after hospital admission

Title

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

Title

Basic activities of daily living score (BADL)

Time Frame

At 28 days after hospital discharge, that is an expected average of 8 weeks

Secondary Outcome Measure Information:

Title

Lung Functional Testing

Time Frame

At the end of hospital stay, with an expected average of 5 weeks

Title

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

Title

ICU mobilization scale

Time Frame

During hospital stay, as expected average of 4 weeks, and at 28 days and at 6 months after discharge

Title

Isometric quadriceps force (N/kg)

Description

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

Title

Walking test distance at six minutes

Time Frame

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

Title

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

Title

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

Other Pre-specified Outcome Measures:

Title

Changes in Pulse Oximeter Oxygen Saturation (SpO2) between end and initial values after physiotherapy sessions

Time Frame

ICU admission, with an expected average of 2 weeks

Title

Change in respiratory rate between end and initial values after physiotherapy sessions

Description

Respiratory rate

Time Frame

ICU admission, with an expected average of 2 weeks

Title

Change in heart rate between end and initial values after physiotherapy sessions

Time Frame

ICU admission, with an expected average of 2 weeks

Title

Change in mean blood pressure between end and initial values after physiotherapy sessions

Time Frame

ICU admission, with an expected average of 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gemma Rialp, M.D.

Phone

00 34 871202133

grialp@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Catalina Morey, Phyt

cati.cmf@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gemma Rialp, M.D.

Organizational Affiliation

IDISPA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Son llàtzer

City

Palma de Mallorca

State/Province

Illes Balears

ZIP/Postal Code

07198

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gemma Rialp, M.D.

Phone

00 34 871202133

grialp@gmail.com

First Name & Middle Initial & Last Name & Degree

Catalina Morey, Phty

First Name & Middle Initial & Last Name & Degree

Noelia Calvo, Phty

First Name & Middle Initial & Last Name & Degree

Catalina Forteza, M.D.

First Name & Middle Initial & Last Name & Degree

Maria Romero, M.D.

First Name & Middle Initial & Last Name & Degree

Alvaro Perez, M.D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

12472328

Citation

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.

Results Reference

result

PubMed Identifier

25715872

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, multi-centre, prospective cohort study. Crit Care. 2015 Feb 26;19(1):81. doi: 10.1186/s13054-015-0765-4.

Results Reference

result

PubMed Identifier

22147819

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.

Results Reference

result

PubMed Identifier

19446324

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, 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.

Results Reference

result

PubMed Identifier

20046132

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.

Results Reference

result

PubMed Identifier

19623052

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.0b013e3181a38937.

Results Reference

result

PubMed Identifier

20406506

Citation

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.

Results Reference

result

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Early Cycloergometric Physiotherapy in Critically Ill Patients With Invasive Mechanical Ventilation

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