Metabolism and Oxygen Consumption During Functional Electrical Stimulation Cycling in COPD
April 17, 2017 updated by: BOUCHRA LAMIA, University Hospital, Rouen
Chronic Obstructive Pulmonary Disease (COPD) had systemic repercussion and lead to peripheral muscular dysfunction. Muscular atrophy limits aerobic capacity and is a major limitation of daily activity and quality of life. Technologies likes' neuromuscular electrical stimulation (NMES) are currently being adapted and tested to support exercise training.
The investigators hypothesized that functional electrical stimulation cycling improves VO2 and aerobic capacities during exercise compared to endurance training.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Montivilliers, France, 76290
- Médrinal
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- COPD (Stade II, III or IV)
- Inform consent
Exclusion Criteria:
- Pulmonary rehabilitation contraindication
- Patient with Pacemaker
- Patient in acute exacerbation
- Patient with neurologic comorbidity
- Anemiae
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: One single arm group
COPD included in a pulmonary rehabilitation program Intervention: Investigators used a bedside cycloergometer with electrical stimulation. COPD perform 2 measure of oxygen uptake during exercise for compare aerobic capacities:
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Patients performed an endurance tests with functional electrical stimulation during 30 minutes with an oxygen uptake measure.
Patients performed an endurance tests on classic ergometer during 30 minutes with a sham electrical stimulation with an oxygen uptake measure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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oxygen uptake (VO2)
Time Frame: during 30 minutes exercise
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during 30 minutes exercise
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)
Time Frame: during 30 minutes exercise
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Number of liters of air must be ventilated to consume 1 liter of O2
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during 30 minutes exercise
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Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)
Time Frame: during 30 minutes exercise
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Number of liters of air must be ventilated to reject 1 liter of CO2
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during 30 minutes exercise
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cardiac output
Time Frame: during 30 minutes exercise
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during 30 minutes exercise
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Muscular fatigue
Time Frame: after 30 minutes exercise
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after 30 minutes exercise
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Clement Medrinal, Groupe Hospitalier Du Havre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Medrinal C, Prieur G, Combret Y, Quesada AR, Debeaumont D, Bonnevie T, Gravier FE, Dupuis Lozeron E, Quieffin J, Contal O, Lamia B. Functional Electrical Stimulation-A New Therapeutic Approach to Enhance Exercise Intensity in Chronic Obstructive Pulmonary Disease Patients: A Randomized, Controlled Crossover Trial. Arch Phys Med Rehabil. 2018 Aug;99(8):1454-1461. doi: 10.1016/j.apmr.2018.02.002. Epub 2018 Mar 7.
- Medrinal C, Prieur G, Debeaumont D, Robledo Quesada A, Combret Y, Quieffin J, Contal O, Lamia B. Comparison of oxygen uptake during cycle ergometry with and without functional electrical stimulation in patients with COPD: protocol for a randomised, single-blind, placebo-controlled, cross-over trial. BMJ Open Respir Res. 2016 Apr 12;3(1):e000130. doi: 10.1136/bmjresp-2016-000130. eCollection 2016.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
October 29, 2015
First Submitted That Met QC Criteria
October 31, 2015
First Posted (Estimate)
November 3, 2015
Study Record Updates
Last Update Posted (Actual)
April 18, 2017
Last Update Submitted That Met QC Criteria
April 17, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 2014-A01690-47
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.