Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2008-12-31
2009-08-31
Brief Summary
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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).
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Interventions
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Neuromuscular Electrical stimulator (Cefar rehab 4 pro)
50Hz 30 min 7 sessions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* absence of vascular pathology
* absence of dermatosis on legs
40 Years
ALL
No
Sponsors
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Laval University
OTHER
Responsible Party
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Laval University
Locations
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Hôpital Laval
Québec, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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CER20357
Identifier Type: -
Identifier Source: org_study_id
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