NCT02594722

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

October 29, 2015

Last Update Submit

April 17, 2017

Conditions

COPD

Keywords

COPDFunctional Electrical Stimulation CyclingPulmonary Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • oxygen uptake (VO2)

    during 30 minutes exercise

Secondary Outcomes (4)

  • Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)

    during 30 minutes exercise

  • Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)

    during 30 minutes exercise

  • cardiac output

    during 30 minutes exercise

  • Muscular fatigue

    after 30 minutes exercise

Study Arms (1)

One single arm group

EXPERIMENTAL

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-cyclingDevice: Classic cycloergometer

Interventions

FES-cyclingDEVICE

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

One single arm group
Classic cycloergometerDEVICE

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

One single arm group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medrinal

Montivilliers, 76290, France

Location

Related Publications (2)

  • 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.

    PMID: 29524398DERIVED

  • 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.

    PMID: 27110364DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clement Medrinal

    Groupe Hospitalier du Havre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 3, 2015

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations

FR(1)