Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment

NCT ID: NCT02226406

Last Updated: 2015-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Legs Cycloergometer Group (A)

Patients randomized in this group will do 10 minutes of legs cycloergometer active exercise. Continuously evaluated with electric impedance tomography.

Group Type EXPERIMENTAL

A: Chair - Leg Cycle ergometer

Intervention Type OTHER

Hands Cycloergometer Group (B)

Patients randomized in this group will do 10 minutes of hand cycloergometer active exercise. Continuously evaluated with electric impedance tomography.

Group Type EXPERIMENTAL

B: Chair - Arm Cycle ergometer

Intervention Type OTHER

Walk in place (C)

Patients randomized in this group will do 10 minutes of active walk in place. Continuously evaluated with electric impedance tomography.

Group Type EXPERIMENTAL

C: Walk in place

Intervention Type OTHER

Interventions

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A: Chair - Leg Cycle ergometer

Intervention Type OTHER

B: Chair - Arm Cycle ergometer

Intervention Type OTHER

C: Walk in place

Intervention Type OTHER

Other Intervention Names

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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 Handcycle Early mobilization Early physical therapy Early physical rehabilitation Early physical training Early physiotherapy Very early mobilization Early exercise Early activity Early mobility therapy 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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricardo Arriagada, PT

Role: PRINCIPAL_INVESTIGATOR

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

Ursula Jeria, PT

Role: PRINCIPAL_INVESTIGATOR

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

Cheryl Hickmann, PT, PhD student

Role: PRINCIPAL_INVESTIGATOR

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

Jean Roeseler, PT, PhD

Role: STUDY_DIRECTOR

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

Pierre-François Laterre, MD

Role: STUDY_CHAIR

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

Locations

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

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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EIT-Early Exercise

Identifier Type: -

Identifier Source: org_study_id

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