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

  • France
      • Montivilliers, France, 76290
        • Médrinal

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
oxygen uptake (VO2)
Time Frame: during 30 minutes exercise
during 30 minutes exercise

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)
Time Frame: during 30 minutes exercise
Number of liters of air must be ventilated to consume 1 liter of O2
during 30 minutes exercise
Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)
Time Frame: during 30 minutes exercise
Number of liters of air must be ventilated to reject 1 liter of CO2
during 30 minutes exercise
cardiac output
Time Frame: during 30 minutes exercise
during 30 minutes exercise
Muscular fatigue
Time Frame: after 30 minutes exercise
after 30 minutes exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

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

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

Keywords

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.

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