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

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

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

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: A: Chair - Leg Cycle ergometer; Other: B: Chair - Arm Cycle ergometer; Other: C: Walk in place

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1200
    • Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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: Early mobilization; Early physical therapy; Early physical rehabilitation; Early physical training; Early physiotherapy; Very early mobilization; Early exercise; Early activity; Early mobility therapy; Handcycle
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; Early physical therapy; Early physical rehabilitation; Early physical training; Early physiotherapy; Very early mobilization; Early exercise; Early activity; Early mobility therapy; March; Static walk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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)

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: August 25, 2014
• First Posted (Estimate): August 27, 2014

Study Record Updates

• Last Update Posted (Estimate): January 14, 2015
• Last Update Submitted That Met QC Criteria: January 13, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Ventilation; Oxygenation; Electrical Impedance Tomography; Early Physical Exercise; Alveolar Recruitment
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: EIT-Early Exercise