Metabolism and Oxygen Consumption During Functional Electrical Stimulation Cycling in COPD

NCT ID: NCT02594722

Last Updated: 2017-04-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

FES-cycling

Intervention Type DEVICE

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

Classic cycloergometer

Intervention Type DEVICE

Patients performed an endurance tests on classic ergometer during 30 minutes with a sham electrical stimulation with an oxygen uptake measure.

Interventions

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FES-cycling

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

Intervention Type DEVICE

Classic cycloergometer

Patients performed an endurance tests on classic ergometer during 30 minutes with a sham electrical stimulation with an oxygen uptake measure.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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BOUCHRA LAMIA

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Clement Medrinal

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier du Havre

Locations

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Medrinal

Montivilliers, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 29524398 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27110364 (View on PubMed)

Other Identifiers

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2014-A01690-47

Identifier Type: -

Identifier Source: org_study_id

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