Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment

NCT02226406 | Completed DMC

• 1 other identifier: EIT-Early Exercise
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Critical Illness

Keywords

Early Physical Exercise; Alveolar Recruitment; Electrical Impedance Tomography; Oxygenation; Ventilation

Outcome Measures

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.

  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

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

Study Arms (3)

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.

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.

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.

Other: C: Walk in place

Interventions

A: Chair - Leg Cycle ergometer OTHER

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

Legs Cycloergometer Group (A)

B: Chair - Arm Cycle ergometer OTHER

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

Hands Cycloergometer Group (B)

C: Walk in place OTHER

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

Walk in place (C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

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

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Critical Illness; Motor Activity; Respiratory Aspiration

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

• Jean Roeseler, PT, PhD

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

  STUDY DIRECTOR

• Pierre-François Laterre, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 27, 2014
• Study Start: July 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

BE (1)