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CompletedNCT02226406EFRAUpdated Jan 14, 2015

Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment

An interventional study of A: Chair - Leg Cycle ergometer and B: Chair - Arm Cycle ergometer in Critical Illness, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-14.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

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Conditions studied

  • Critical Illness

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Keywords

  • Early Physical Exercise
  • Alveolar Recruitment
  • Electrical Impedance Tomography
  • Oxygenation
  • Ventilation
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 461 are open to participants now.

This study's enrollment of 50 is below the median of 90 across 979 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • OtherA: Chair - Leg Cycle ergometer

    Also known as: 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

  • OtherB: Chair - Arm Cycle ergometer

    Also known as: Handcycle, Early mobilization, Early physical therapy, Early physical rehabilitation, Early physical training, Early physiotherapy, Very early mobilization, Early exercise, Early activity, Early mobility therapy

  • OtherC: Walk in place

    Also known as: 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Meassure of EIT after 10 minutes of exercise and will be compared with baseline EIT

Secondary outcomes

  1. 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.

    Time frame: Measure of PaO2 after 20 minutes of exercise and will compared with baseline PaO2

07

Study locations

1 site
  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
    Brussel, 1200, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02226406
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Sponsor
First posted
Aug 27, 2014
Start date
Jul 2014
Primary completion
Nov 2014
Completion
Dec 2014
Last update
Jan 14, 2015

Study contacts

Ricardo Arriagada, PT
principal investigator · Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Ursula Jeria, PT
principal investigator · Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Cheryl Hickmann, PT, PhD student
principal investigator · Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Jean Roeseler, PT, PhD
study director · Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Pierre-François Laterre, MD
study chair · Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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