Early Rehabilitation of COPD Patients in ICU | NCT00628992

Studies
Early Rehabilitation of COPD Patients in ICU

NCT00628992

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Mar 27, 2015Estimated

Enrollment

5Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease
Acute Respiratory Failure

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Nov 2008Actual

Completion Date

Sep 2011Actual

First Submitted Date

Feb 4, 2008

First Submission Date that Met QC Criteria

Feb 25, 2008

First Posted Date

Mar 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2015

Last Update Posted Date

Mar 27, 2015Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Other	Other: No specific intervention, standard therapy serving as a control group, passive mobilization of the legs
2	Active Comparator	Other: Electrical stimulation of the thigh
3	Active Comparator	Other: Cycloergometer training
4	Active Comparator	Other: Electrical stimulation of the thigh and cycloergometer training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No specific intervention, standard therapy serving as a control group, passive mobilization of the legs	Other	Muscular rehabilitation of the leg	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number day breathing without assistance during the 28-day study period		during the 28-day study period

Secondary Outcomes

Measure	Description	Time Frame
Mortality at day 28 and day 90		Measured within the ICU stay of the patient
Length of stay in intensive care unit and hospital		Measured within the ICU stay of the patient

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vincent CASTELAIN, MD	Hôpitaux Universitaires de Strasbourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Réanimation Médicale, Hôpital Civil, Hôpitaux Universitaires de Strasbourg		Strasbourg		67091	France

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms