Metabolism and Oxygen Consumption During Functional Electrical Stimulation Cycling in COPD

COPD Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594722
• Other study ID #: 2014-A01690-47
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2015
• Last updated: April 17, 2017
• Start date: April 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

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

Locations

Country	Name	City	State
France	Medrinal	Montivilliers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygen uptake (VO2)		during 30 minutes exercise
Secondary	Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)	Number of liters of air must be ventilated to consume 1 liter of O2	during 30 minutes exercise
Secondary	Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)	Number of liters of air must be ventilated to reject 1 liter of CO2	during 30 minutes exercise
Secondary	cardiac output		during 30 minutes exercise
Secondary	Muscular fatigue		after 30 minutes exercise