COPDTOESNCT00809120
Tolerance to Electrostimulation in COPD Patients
A study testing Neuromuscular Electrical stimulator (Cefar rehab 4 pro) in people with COPD, run by Laval University at 1 site in Canada.
Trial summary
The study was designed to test the following hypothesis Patients with high cardio-respiratory response to electrostimulation (ES), high perception of pain during ES and high ES-induced muscle fatigue, have low tolerance to ES (more difficulties to increase intensity during training). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Neuromuscular Electrical stimulator (Cefar rehab 4 pro)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2008to Aug 2009
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is diagnosed with COPD.
- 40 years-old and older
- Currently or previously smoking with a smoking history of at least 10 pack-years
- Subject understands and is able to read and write French or English
Who cannot join
- absence of neuromuscular pathology
- absence of vascular pathology
- absence of dermatosis on legs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Clinical Tolerance, Cardio-respiratory Response and Muscle Fatigue During Electrostimulation
The study was designed to test the following hypothesis
Patients with high cardio-respiratory response to electrostimulation (ES), high perception of pain during ES and high ES-induced muscle fatigue, have low tolerance to ES (more difficulties to increase intensity during training).
Read the detailed description
Background: Muscle electrostimulation (ES) appears as a promising alternative to general physical reconditioning in advanced COPD and its feasibility has been confirmed in this population. However, patients are not equal in tolerance to ES. Certain patients are not able to increase ES intensity during training, limiting its benefits. Furthermore, little is known about the effect of one ES training session on cardio-respiratory response, muscle fatigue and systemic inflammation in COPD patients.
Objective: To evaluate the tolerance to ES in COPD patients and to identify the physiological parameters involved in ES tolerance.
Method: We propose to conduct a prospective study including 21 COPD patients of different pulmonary severity (7 in each group of GOLD II, III and IV). Patients will be evaluated 3 times: at day 1, day 2 and day 9. In the first session, patients will be initiated to ES and evaluated in walking distance. In the second session, patients will become autonomous with ES and they will be evaluated in muscle strength and body composition. In the third session, cardio-respiratory measurements will be performed during ES and patients will be evaluated in muscle strength and systemic inflammation (blood sampling) before and after ES. Between the 2d and the 3d sessions, patients will have to perform 5 ES sessions at home (from day 3 to day 8). Tolerance (symptoms assessed with visual analogical scale (VAS)) and intensity of ES will be measured during each ES session.
Planning analysis: The main outcome will be the change in ES intensity between session 2 and 3 (delta intensity). The other end-points will be minute ventilation, heart rate, VO2 and SaO2 during ES, but also change in ES tolerance (VAS) during ES at equal ES intensity, leg muscle fatigue after ES, body composition and changes in plasmatic proteins after ES. Simple and multiple regressions analysis will be done between delta intensity and 1/cardio-respiratory response during ES, 2/muscle fatigue after ES, 3/body composition, 4/perception of pain at session 2 (VAS), 5/changes in plasmatic proteins after ES.
- Conditions
- COPD
- Being tested
- Neuromuscular Electrical stimulator (Cefar rehab 4 pro)
- Keywords
- Electrostimulation, COPD, Tolerance, Muscle fatigue, Cardio-respiratory response
- 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.
Neuromuscular Electrical stimulator (Cefar rehab 4 pro)Device
Also called NMES
50Hz 30 min 7 sessions
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance to ES = Change in ES intensity between session 2 and 3 (delta intensity)
Measured: 1 week
Secondary outcomes (5)
Cardiorespiratory response during ES
Measured: 1 week
Muscle fatigue after ES
Measured: 1 week
Body composition
Measured: 1 week
Perception of pain at session 2 (symptoms on Visual Analogic Scale)
Measured: 1 week
Plasmatic proteins after ES
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809120
- Sponsor's protocol ID
- CER20357
- Acronym
- TOES
- Status last verified
- Sep 2008
- First submitted
- 16 Dec 2008
- Last updated
- 10 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Vivodtzev I, Rivard B, Gagnon P, Mainguy V, Dube A, Belanger M, Jean B, Maltais F. Tolerance and physiological correlates of neuromuscular electrical stimulation in COPD: a pilot study. PLoS One. 2014 May 9;9(5):e94850. doi: 10.1371/journal.pone.0094850. eCollection 2014.
PubMed 24817528
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Clinical Tolerance, Cardio-respiratory Response and Muscle Fatigue During Electrostimulation
- ClinicalTrials.gov ID
- NCT00809120
- Acronym / sponsor ID
- TOES / CER20357
- Conditions
- COPD
- Keywords
- Electrostimulation, COPD, Tolerance, Muscle fatigue, Cardio-respiratory response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 17 Dec 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.
The study was designed to test the following hypothesis
Patients with high cardio-respiratory response to electrostimulation (ES), high perception of pain during ES and high ES-induced muscle fatigue, have low tolerance to ES (more difficulties to increase intensity during training).
Detailed description
Background: Muscle electrostimulation (ES) appears as a promising alternative to general physical reconditioning in advanced COPD and its feasibility has been confirmed in this population. However, patients are not equal in tolerance to ES. Certain patients are not able to increase ES intensity during training, limiting its benefits. Furthermore, little is known about the effect of one ES training session on cardio-respiratory response, muscle fatigue and systemic inflammation in COPD patients.
Objective: To evaluate the tolerance to ES in COPD patients and to identify the physiological parameters involved in ES tolerance.
Method: We propose to conduct a prospective study including 21 COPD patients of different pulmonary severity (7 in each group of GOLD II, III and IV). Patients will be evaluated 3 times: at day 1, day 2 and day 9. In the first session, patients will be initiated to ES and evaluated in walking distance. In the second session, patients will become autonomous with ES and they will be evaluated in muscle strength and body composition. In the third session, cardio-respiratory measurements will be performed during ES and patients will be evaluated in muscle strength and systemic inflammation (blood sampling) before and after ES. Between the 2d and the 3d sessions, patients will have to perform 5 ES sessions at home (from day 3 to day 8). Tolerance (symptoms assessed with visual analogical scale (VAS)) and intensity of ES will be measured during each ES session.
Planning analysis: The main outcome will be the change in ES intensity between session 2 and 3 (delta intensity). The other end-points will be minute ventilation, heart rate, VO2 and SaO2 during ES, but also change in ES tolerance (VAS) during ES at equal ES intensity, leg muscle fatigue after ES, body composition and changes in plasmatic proteins after ES. Simple and multiple regressions analysis will be done between delta intensity and 1/cardio-respiratory response during ES, 2/muscle fatigue after ES, 3/body composition, 4/perception of pain at session 2 (VAS), 5/changes in plasmatic proteins after ES.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is diagnosed with COPD.
- 40 years-old and older
- Currently or previously smoking with a smoking history of at least 10 pack-years
- Subject understands and is able to read and write French or English
Key exclusion criteria (3 listed)
- absence of neuromuscular pathology
- absence of vascular pathology
- absence of dermatosis on legs
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 |
|---|---|---|
| Neuromuscular Electrical stimulator (Cefar rehab 4 pro)Also: NMES50Hz 30 min 7 sessions | Device | – |
Primary outcome
Tolerance to ES = Change in ES intensity between session 2 and 3 (delta intensity)
Time frame: 1 week
5 secondary outcomes
Cardiorespiratory response during ES
Time frame: 1 week
Muscle fatigue after ES
Time frame: 1 week
Body composition
Time frame: 1 week
Perception of pain at session 2 (symptoms on Visual Analogic Scale)
Time frame: 1 week
Plasmatic proteins after ES
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2010.
- Derived from this study: PubMed 24817528Vivodtzev I, Rivard B, Gagnon P, Mainguy V, Dube A, Belanger M, Jean B, Maltais F. Tolerance and physiological correlates of neuromuscular electrical stimulation in COPD: a pilot study. PLoS One. 2014 May 9;9(5):e94850. doi: 10.1371/journal.pone.0094850. eCollection 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical stimulator (Cefar rehab 4 pro) in people with COPD, run by Laval University at 1 site in Canada.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 10 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tolerance to ES = Change in ES intensity between session 2 and 3 (delta intensity) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00809120, which also lists 1 linked publication.
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 10 Jun 2010.