EFRA: Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)

Overall Status

Completed

CT.gov ID

NCT02226406

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

9.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Critical Illness	Other: A: Chair - Leg Cycle ergometer Other: B: Chair - Arm Cycle ergometer Other: C: Walk in place	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment Evaluated With Electric Impedance Tomography.

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Legs Cycloergometer Group (A) Patients randomized in this group will do 10 minutes of legs cycloergometer active exercise. Continuously evaluated with electric impedance tomography.	Other: A: Chair - Leg Cycle ergometer Other Names: 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
Experimental: Hands Cycloergometer Group (B) Patients randomized in this group will do 10 minutes of hand cycloergometer active exercise. Continuously evaluated with electric impedance tomography.	Other: B: Chair - Arm Cycle ergometer Other Names: Handcycle Early mobilization Early physical therapy Early physical rehabilitation Early physical training Early physiotherapy Very early mobilization Early exercise Early activity Early mobility therapy
Experimental: Walk in place (C) Patients randomized in this group will do 10 minutes of active walk in place. Continuously evaluated with electric impedance tomography.	Other: C: Walk in place Other Names: 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

Arm

Intervention/Treatment

Experimental: Legs Cycloergometer Group (A)

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

Other: A: Chair - Leg Cycle ergometer

Other Names:

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

Experimental: Hands Cycloergometer Group (B)

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

Other: B: Chair - Arm Cycle ergometer

Other Names:

Handcycle

Early mobilization

Early physical therapy

Early physical rehabilitation

Early physical training

Early physiotherapy

Very early mobilization

Early exercise

Early activity

Early mobility therapy

Experimental: Walk in place (C)

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

Other: C: Walk in place

Other Names:

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

Outcome Measures

Primary Outcome Measures

Change in pulmonary electric impedance tomography (EIT) before, during and after single session of exercise. [Meassure of EIT after 10 minutes of exercise and will be compared with baseline EIT]
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 [Measure of PaO2 after 20 minutes of exercise and will compared with baseline PaO2]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)	Brussel		Belgium	1200

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

Principal Investigator: Ricardo Arriagada, PT, Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Principal Investigator: Ursula Jeria, PT, Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Principal Investigator: Cheryl Hickmann, PT, PhD student, Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Study Director: Jean Roeseler, PT, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Study Chair: Pierre-François Laterre, MD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)