Critical IllnessEFRANCT02226406
Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment
A study testing A: Chair - Leg Cycle ergometer, B: Chair - Arm Cycle ergometer and C: Walk in place in people with Critical Illness, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness
- What is being tested?
- A: Chair - Leg Cycle ergometer, B: Chair - Arm Cycle ergometer and C: Walk in place
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- PEEP > 15 cm H2
- Acute Myocardial Infarction
- Active bleeding
- Intracranial pressure > 20 mm Hg or with major instability
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Brussels, 1200
About this study
Official title: 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.
Read more
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
- Conditions
- Critical Illness
- Being tested
- A: Chair - Leg Cycle ergometer, B: Chair - Arm Cycle ergometer, C: Walk in place
- Keywords
- Early Physical Exercise, Alveolar Recruitment, Electrical Impedance Tomography, Oxygenation, Ventilation
- Medical subject headings
- Critical Illness, Motor Activity, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A: Chair - Leg Cycle ergometerOther
Also called Exercise Bike, Early mobilization, Early physical therapy, Early physical rehabilitation
B: Chair - Arm Cycle ergometerOther
Also called Handcycle, Early mobilization, Early physical therapy, Early physical rehabilitation
C: Walk in placeOther
Also called Early mobilization, March, Static walk, Early physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Legs Cycloergometer Group (A) | Experimental | Patients randomized in this group will do 10 minutes of legs cycloergometer active exercise. Continuously evaluated with electric impedance tomography. Receives: Other: A: Chair - Leg Cycle ergometer |
| Hands Cycloergometer Group (B) | Experimental | Patients randomized in this group will do 10 minutes of hand cycloergometer active exercise. Continuously evaluated with electric impedance tomography. Receives: Other: B: Chair - Arm Cycle ergometer |
| Walk in place (C) | Experimental | Patients randomized in this group will do 10 minutes of active walk in place. Continuously evaluated with electric impedance tomography. Receives: Other: C: Walk in place |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Measure of PaO2 after 20 minutes of exercise and will compared with baseline PaO2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226406
- Sponsor's protocol ID
- EIT-Early Exercise
- Acronym
- EFRA
- Status last verified
- Jan 2015
- First submitted
- 31 Jul 2014
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment Evaluated With Electric Impedance Tomography.
- ClinicalTrials.gov ID
- NCT02226406
- Acronym / sponsor ID
- EFRA / EIT-Early Exercise
- Conditions
- Critical Illness
- Keywords
- Early Physical Exercise, Alveolar Recruitment, Electrical Impedance Tomography, Oxygenation, Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Legs Cycloergometer Group (A) | Experimental | Other: A: Chair - Leg Cycle ergometerPatients randomized in this group will do 10 minutes of legs cycloergometer active exercise. Continuously evaluated with electric impedance tomography. |
| Hands Cycloergometer Group (B) | Experimental | Other: B: Chair - Arm Cycle ergometerPatients randomized in this group will do 10 minutes of hand cycloergometer active exercise. Continuously evaluated with electric impedance tomography. |
| Walk in place (C) | Experimental | Other: C: Walk in placePatients randomized in this group will do 10 minutes of active walk in place. Continuously evaluated with electric impedance tomography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- With risk of evisceration
- Therapy withdrawal
- With cardiac devices (Pace Maker)
- Persistent cough
- Patches or open wounds in zone of electrodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A: Chair - Leg Cycle ergometerAlso: Exercise Bike, Early mobilization, Early physical therapy, Early physical rehabilitation | Other | Legs Cycloergometer Group (A) |
| B: Chair - Arm Cycle ergometerAlso: Handcycle, Early mobilization, Early physical therapy, Early physical rehabilitation | Other | Hands Cycloergometer Group (B) |
| C: Walk in placeAlso: Early mobilization, March, Static walk, Early physical therapy | Other | Walk in place (C) |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A: Chair - Leg Cycle ergometer, B: Chair - Arm Cycle ergometer and C: Walk in place in people with Critical Illness, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.