Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment

Critical Illness Clinical Trial

— EFRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226406
• Other study ID #: EIT-Early Exercise
• Status: Completed
• Phase: N/A
• First received: July 31, 2014
• Last updated: January 13, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• A: Chair - Leg Cycle ergometer

• B: Chair - Arm Cycle ergometer

• C: Walk in place

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Meassure of EIT after 10 minutes of exercise and will be compared with baseline EIT	No
Secondary	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.	Measure of PaO2 after 20 minutes of exercise and will compared with baseline PaO2	No