Chronic Obstructive Pulmonary DiseaseNCT00628992
Early Rehabilitation of COPD Patients in ICU
A study testing Electrical stimulation of the thigh, Cycloergometer training and Electrical stimulation of the thigh and cycloergometer training in people with Chronic Obstructive Pulmonary Disease and Acute Respiratory Failure, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Acute Respiratory Failure
- What is being tested?
- Electrical stimulation of the thigh, Cycloergometer training and Electrical stimulation of the thigh and cycloergometer training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 4 sitesFrance
- Study dates
- Feb 2008to Sep 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients not affiliated with a Social Security System
- Patients under justice safeguard
- Patients under curator ship
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service de Réanimation Médicale, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Service des Explorations Fonctionnelles Respiratoires, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
Service de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
About this study
Official title: Effects of Early Rehabilitation in Chronic Obstructive Pulmonary Disease Patients Under Mechanical Ventilation for Acute Respiratory Failure in Intensive Care Unit.
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.
- Being tested
- 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
- Keywords
- COPD: chronic obstructive pulmonary disease and acute respiratory failure
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No specific intervention, standard therapy serving as a control group, passive mobilization of the legsOther
Muscular rehabilitation of the leg
Electrical stimulation of the thighOther
Muscular rehabilitation of the leg
Cycloergometer trainingOther
Muscular rehabilitation of the leg
Electrical stimulation of the thigh and cycloergometer trainingOther
Muscular rehabilitation of the leg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Other: No specific intervention, standard therapy serving as a control group, passive mobilization of the legs |
| 2 | Active comparator | Not described Receives: Other: Electrical stimulation of the thigh |
| 3 | Active comparator | Not described Receives: Other: Cycloergometer training |
| 4 | Active comparator | Not described Receives: Other: Electrical stimulation of the thigh and cycloergometer training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number day breathing without assistance during the 28-day study period
Measured: during the 28-day study period
Secondary outcomes (3)
Mortality at day 28 and day 90
Measured: Measured within the ICU stay of the patient
Length of stay in intensive care unit and hospital
Measured: Measured within the ICU stay of the patient
Clinical measurement of muscular strength in lower limbs(day 0-2 and day 28-30)
Measured: Measured within the ICU stay of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionNov 2008
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent CASTELAIN, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628992
- Sponsor's protocol ID
- 3912
- Status last verified
- Mar 2015
- First submitted
- 4 Feb 2008
- Last updated
- 27 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Rehabilitation in Chronic Obstructive Pulmonary Disease Patients Under Mechanical Ventilation for Acute Respiratory Failure in Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT00628992
- Acronym / sponsor ID
- 3912
- Keywords
- COPD: chronic obstructive pulmonary disease and acute respiratory failure
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 5 Mar 2008 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- Non chronic obstructive pulmonary disease
- Lack of patient involvement
- Minor Patients
- Patients under guardianship
- Unconscious and non cooperative state
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 |
|---|---|---|
| No specific intervention, standard therapy serving as a control group, passive mobilization of the legsMuscular rehabilitation of the leg | Other | 1 |
| Electrical stimulation of the thighMuscular rehabilitation of the leg | Other | 2 |
| Cycloergometer trainingMuscular rehabilitation of the leg | Other | 3 |
| Electrical stimulation of the thigh and cycloergometer trainingMuscular rehabilitation of the leg | Other | 4 |
Primary outcome
Number day breathing without assistance during the 28-day study period
Time frame: during the 28-day study period
3 secondary outcomes
Mortality at day 28 and day 90
Time frame: Measured within the ICU stay of the patient
Length of stay in intensive care unit and hospital
Time frame: Measured within the ICU stay of the patient
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 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.
Vincent CASTELAIN, MD principal investigator
Hôpitaux Universitaires de Strasbourg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation of the thigh, Cycloergometer training and Electrical stimulation of the thigh and cycloergometer training in people with Chronic Obstructive Pulmonary Disease and Acute Respiratory Failure, run by University Hospital, Strasbourg, France at 4 sites in France.
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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 was stopped early. Results are not available in the source record.
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?
Number day breathing without assistance during the 28-day study period (time frame: during the 28-day study period). 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 27 Mar 2015.