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Early Rehabilitation of COPD Patients in ICU

Primary Purpose

Chronic Obstructive Pulmonary Disease, Acute Respiratory Failure

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
No specific intervention, standard therapy serving as a control group, passive mobilization of the legs
Electrical stimulation of the thigh
Cycloergometer training
Electrical stimulation of the thigh and cycloergometer training
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD: chronic obstructive pulmonary disease and acute respiratory failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient older than 18 years of age
  • Chronic obstructive pulmonary disease
  • Intubated with mechanical ventilation
  • Patients without sedation or catecholamine
  • 2 previous spontaneous breathing trial at 24 hour intervals with T-piece having been unsuccessful
  • Conscious and cooperative state
  • Ability for the patient to sit in a armchair

Exclusion Criteria:

  • Non chronic obstructive pulmonary disease
  • Lack of patient involvement
  • Minor Patients
  • Patients under guardianship
  • Unconscious and non cooperative state
  • Patients unable to ride in a wheelchair
  • Patients not affiliated with a Social Security System
  • Patients under justice safeguard
  • Patients under curator ship

Sites / Locations

  • Service de Réanimation Médicale, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
  • Service des Explorations Fonctionnelles Respiratoires, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
  • Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
  • Service de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Number day breathing without assistance during the 28-day study period

Secondary Outcome Measures

Mortality at day 28 and day 90
Length of stay in intensive care unit and hospital
Clinical measurement of muscular strength in lower limbs(day 0-2 and day 28-30)

Full Information

First Posted
February 4, 2008
Last Updated
March 26, 2015
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT00628992
Brief Title
Early Rehabilitation of COPD Patients in ICU
Official Title
Effects of Early Rehabilitation in Chronic Obstructive Pulmonary Disease Patients Under Mechanical Ventilation for Acute Respiratory Failure in Intensive Care Unit.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Study Start Date
February 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

5. Study Description

Brief Summary
Twenty per cent of the intensive care patients mechanically ventilated suffer from chronic obstructive pulmonary disease (COPD). These patients stay longer in Intensive Care which is more costly and they are more prone to nosocomial infection.In addition, they are longer bedridden and they develop muscular weakness.Prolonged inactivity results in respiratory and skeletal muscle weakness which curtails simple daily activity.The principal purpose of this study is to compare two types of muscular rehabilitation (electrical stimulation of the thigh and/or cycloergometer training) to classic passive mobilization of the leg.The second purpose is to analyse the effects of each type of rehabilitation on muscular fiber (structural and functional analysis) by muscular biopsies.Two hundred forty COPD patients admitted in the intensive care unit for acute respiratory failure will be randomized in 4: 1 fashion to receive passive mobilization of the legs(group 1, n=60), electrical stimulation of the thigh (group 2, n=60), cycloergometer training (group 3, n=60) or electrical stimulation of the thigh and cycloergometer training(group 4, n=60).The rehabilitation program will last 4 weeks with 5 sessions per week.In each group of patients, muscular biopsies will be done under local anaesthesia at the beginning and end of the rehabilitation programme and when they are discharged from the service.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Acute Respiratory Failure
Keywords
COPD: chronic obstructive pulmonary disease and acute respiratory failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
No specific intervention, standard therapy serving as a control group, passive mobilization of the legs
Intervention Description
Muscular rehabilitation of the leg
Intervention Type
Other
Intervention Name(s)
Electrical stimulation of the thigh
Intervention Description
Muscular rehabilitation of the leg
Intervention Type
Other
Intervention Name(s)
Cycloergometer training
Intervention Description
Muscular rehabilitation of the leg
Intervention Type
Other
Intervention Name(s)
Electrical stimulation of the thigh and cycloergometer training
Intervention Description
Muscular rehabilitation of the leg
Primary Outcome Measure Information:
Title
Number day breathing without assistance during the 28-day study period
Time Frame
during the 28-day study period
Secondary Outcome Measure Information:
Title
Mortality at day 28 and day 90
Time Frame
Measured within the ICU stay of the patient
Title
Length of stay in intensive care unit and hospital
Time Frame
Measured within the ICU stay of the patient
Title
Clinical measurement of muscular strength in lower limbs(day 0-2 and day 28-30)
Time Frame
Measured within the ICU stay of the patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient older than 18 years of age Chronic obstructive pulmonary disease Intubated with mechanical ventilation Patients without sedation or catecholamine 2 previous spontaneous breathing trial at 24 hour intervals with T-piece having been unsuccessful Conscious and cooperative state Ability for the patient to sit in a armchair Exclusion Criteria: Non chronic obstructive pulmonary disease Lack of patient involvement Minor Patients Patients under guardianship Unconscious and non cooperative state Patients unable to ride in a wheelchair Patients not affiliated with a Social Security System Patients under justice safeguard Patients under curator ship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent CASTELAIN, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Réanimation Médicale, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Service des Explorations Fonctionnelles Respiratoires, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Service de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France

12. IPD Sharing Statement

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Early Rehabilitation of COPD Patients in ICU

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