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NCT Number: NCT02226406

Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment

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

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Key information

Conditions

Critical Illness Behavior Disease Attributes Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A: Chair - Leg Cycle ergometer

Other

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

B: Chair - Arm Cycle ergometer

Other

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

C: Walk in place

Other

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

Primary outcomes

  1. Change in pulmonary electric impedance tomography (EIT) before, during and after single session of exercise.

    Time frame: 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 outcomes

  1. Change in PaO2 before, during and after single session of exercise

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Acronym: EFRA

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 27, 2014
Registry last updated
Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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