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Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment (EFRA)

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
A: Chair - Leg Cycle ergometer
B: Chair - Arm Cycle ergometer
C: Walk in place
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Critical Illness focused on measuring Early Physical Exercise, Alveolar Recruitment, Electrical Impedance Tomography, Oxygenation, Ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient admitted at the Intensive Care Medical/Surgical Unit of Clinic Saint Luc
  • Days of hospitalization between 1 and 10
  • Hemodynamically stable
  • Patient or family member sign the informed consent

Exclusion Criteria:

  • With risk of evisceration
  • Therapy withdrawal
  • With cardiac devices (Pace Maker)
  • Persistent cough
  • Patches or open wounds in zone of electrodes
  • Presence of high vasopressor medication (noradrenaline > 3 mg/h)
  • PEEP > 15 cm H2
  • Acute Myocardial Infarction
  • Active bleeding
  • Intracranial pressure > 20 mm Hg or with major instability

Sites / Locations

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Legs Cycloergometer Group (A)

Hands Cycloergometer Group (B)

Walk in place (C)

Arm Description

Patients randomized in this group will do 10 minutes of legs cycloergometer active exercise. Continuously evaluated with electric impedance tomography.

Patients randomized in this group will do 10 minutes of hand cycloergometer active exercise. Continuously evaluated with electric impedance tomography.

Patients randomized in this group will do 10 minutes of active walk in place. Continuously evaluated with electric impedance tomography.

Outcomes

Primary Outcome Measures

Change in pulmonary electric impedance tomography (EIT) before, during and after single session of exercise.
The change in pulmonary recruitment and ventilation will be evaluated with electric impedance tomography (EIT) in single session of exercise. First measure will be made for five minutes with EIT, before the exercise, then second measure will be made during exercise for ten minutes with EIT and finally last measure will be made after exercise for twenty minutes with EIT. All impedanciometries obtained in the patient in different activities will compare each.

Secondary Outcome Measures

Change in PaO2 before, during and after single session of exercise
Before exercise will be taken a sample of arterial blood gases for determinate the initial PaO2 of the patient. Twenty minutes after exercise will be taken a new sample of arterial blood gases to establish the difference between PaO2 before exercise and after exercise.

Full Information

First Posted
July 31, 2014
Last Updated
January 13, 2015
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT02226406
Brief Title
Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment
Acronym
EFRA
Official Title
Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment Evaluated With Electric Impedance Tomography.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In the critically patient bed rest and immobilization are some of the responsable of the development of respiratory complications. Early physical exercise is a tool to prevent respiratory complications as lost of respiratory muscle strength, decrease in functional residual capacity and hypoxemia improving oxygenation. New technology as electrical impedance tomography (EIT) are available to visualize changes of regional lung aeration. The aim of this study is to assess the effect of early physical exercise improving alveolar recruitment and pulmonary ventilation in intensive care unit (ICU) patients, evaluated with EIT. The ICU patients included at day of evaluation will be evaluated continuously with EIT in different positions. 1) in the supine position (at 30° of inclination), 2) Sitting in chair 3) Active physical exercise 4) And rest in chair after exercise

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Early Physical Exercise, Alveolar Recruitment, Electrical Impedance Tomography, Oxygenation, Ventilation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Legs Cycloergometer Group (A)
Arm Type
Experimental
Arm Description
Patients randomized in this group will do 10 minutes of legs cycloergometer active exercise. Continuously evaluated with electric impedance tomography.
Arm Title
Hands Cycloergometer Group (B)
Arm Type
Experimental
Arm Description
Patients randomized in this group will do 10 minutes of hand cycloergometer active exercise. Continuously evaluated with electric impedance tomography.
Arm Title
Walk in place (C)
Arm Type
Experimental
Arm Description
Patients randomized in this group will do 10 minutes of active walk in place. Continuously evaluated with electric impedance tomography.
Intervention Type
Other
Intervention Name(s)
A: Chair - Leg Cycle ergometer
Other Intervention Name(s)
Exercise Bike, Early mobilization, Early physical therapy, Early physical rehabilitation, Early physical training, Early physiotherapy, Very early mobilization, Early exercise, Early activity, Early mobility therapy
Intervention Type
Other
Intervention Name(s)
B: Chair - Arm Cycle ergometer
Other Intervention Name(s)
Handcycle, Early mobilization, Early physical therapy, Early physical rehabilitation, Early physical training, Early physiotherapy, Very early mobilization, Early exercise, Early activity, Early mobility therapy
Intervention Type
Other
Intervention Name(s)
C: Walk in place
Other Intervention Name(s)
Early mobilization, March, Static walk, Early physical therapy, Early physical rehabilitation, Early physical training, Early physiotherapy, Very early mobilization, Early exercise, Early activity, Early mobility therapy
Primary Outcome Measure Information:
Title
Change in pulmonary electric impedance tomography (EIT) before, during and after single session of exercise.
Description
The change in pulmonary recruitment and ventilation will be evaluated with electric impedance tomography (EIT) in single session of exercise. First measure will be made for five minutes with EIT, before the exercise, then second measure will be made during exercise for ten minutes with EIT and finally last measure will be made after exercise for twenty minutes with EIT. All impedanciometries obtained in the patient in different activities will compare each.
Time Frame
Meassure of EIT after 10 minutes of exercise and will be compared with baseline EIT
Secondary Outcome Measure Information:
Title
Change in PaO2 before, during and after single session of exercise
Description
Before exercise will be taken a sample of arterial blood gases for determinate the initial PaO2 of the patient. Twenty minutes after exercise will be taken a new sample of arterial blood gases to establish the difference between PaO2 before exercise and after exercise.
Time Frame
Measure of PaO2 after 20 minutes of exercise and will compared with baseline PaO2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient admitted at the Intensive Care Medical/Surgical Unit of Clinic Saint Luc Days of hospitalization between 1 and 10 Hemodynamically stable Patient or family member sign the informed consent Exclusion Criteria: With risk of evisceration Therapy withdrawal With cardiac devices (Pace Maker) Persistent cough Patches or open wounds in zone of electrodes Presence of high vasopressor medication (noradrenaline > 3 mg/h) PEEP > 15 cm H2 Acute Myocardial Infarction Active bleeding Intracranial pressure > 20 mm Hg or with major instability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Arriagada, PT
Organizational Affiliation
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ursula Jeria, PT
Organizational Affiliation
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheryl Hickmann, PT, PhD student
Organizational Affiliation
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Roeseler, PT, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pierre-François Laterre, MD
Organizational Affiliation
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Official's Role
Study Chair
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
City
Brussel
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

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Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment

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