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CompletedNCT02594722Updated Apr 18, 2017

Metabolism and Oxygen Consumption During Functional Electrical Stimulation Cycling in COPD

A Phase 3 interventional study of FES-cycling and Classic cycloergometer in COPD, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-18.

Sponsored by University Hospital, Rouen · Phase 3, Interventional, and Supportive care

Phase
Phase 3
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • COPD

Keywords

  • COPD
  • Functional Electrical Stimulation Cycling
  • Pulmonary Rehabilitation
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In context

Lead sponsor

University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • COPD (Stade II, III or IV)
  • Inform consent

Exclusion criteria

Exclusion Criteria:

  • Pulmonary rehabilitation contraindication
  • Patient with Pacemaker
  • Patient in acute exacerbation
  • Patient with neurologic comorbidity
  • Anemiae
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Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • 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: * Functional Electrical Stimulation Cycling (FES-cycling) * Classic Cycloergometer endurance training with a sham electrical stimulation

    Device: FES-cycling · Device: Classic cycloergometer

Interventions

  • DeviceFES-cycling

    Patients performed an endurance tests with functional electrical stimulation during 30 minutes with an oxygen uptake measure.

  • DeviceClassic cycloergometer

    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 researchers measure

Primary outcomes

  1. oxygen uptake (VO2)

    Time frame: during 30 minutes exercise

Secondary outcomes

  1. Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)

    Number of liters of air must be ventilated to consume 1 liter of O2

    Time frame: during 30 minutes exercise

  2. Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)

    Number of liters of air must be ventilated to reject 1 liter of CO2

    Time frame: during 30 minutes exercise

  3. cardiac output

    Time frame: during 30 minutes exercise

  4. Muscular fatigue

    Time frame: after 30 minutes exercise

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Study locations

1 site
  • Medrinal
    Montivilliers, 76290, France
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References and documents

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. PubMed 29524398 ↗
  • 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. PubMed 27110364 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02594722
Lead sponsor
University Hospital, Rouen
Responsible party
BOUCHRA LAMIA (MD, PhD, University Hospital, Rouen) — Principal investigator
First posted
Nov 3, 2015
Start date
Apr 2016
Primary completion
Apr 2017
Completion
Apr 2017
Last update
Apr 18, 2017

Study contacts

Clement Medrinal
principal investigator · Groupe Hospitalier du Havre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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