Trial Synopsis

Effect of Neuromuscular Electrical Stimulation Versus Cycle
Ergometer Training in a Pulmonary Rehabilitation Program
Status: Recruiting
Study Phase: N/A
Start Date: June 2016 | Completion Date: August 2019
Condition(s): COPD
Full Title of Study
Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a
Pulmonary Rehabilitation Program
Overview
The aim of this study is to evaluate the effectiveness of quadriceps strengthening with
neuromuscular electrical stimulation versus cycle ergometer as part of pulmonary
rehabilitation program , in patients with severe or very severe COPD , according to
GOLD with BODE index ≥ 5 .
Detailed Description
It's a prospective ,multicentre,randomised, single-blind study which compare the
effectiveness of quadriceps strengthening with neuromuscular electrical stimulation
versus cycle ergometer training as part of pulmonary rehabilitation program. The
program lasts from 3 to 4 weeks. 102 patients will included, diagnosed with COPD
stages GOLD III and IV, and BODE index ≥ 5. The commun program: training protocol
performed on treadmill,quadriceps resistance training,patient therapeutic
education,collective gymnastics,relaxation, session psychological care, smoking
cessation program and nutritional management if necessary. The primary criterion is
the one minute sit to stand test.
Study Details
Study Type: Interventional
Study Design
: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model:
Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Investigator Details
Lead Sponsor: University Hospital, Brest
Principal Investigator: Francis Couturaud, MD, PhD University Hospital, Brest
Trial Location Details
Facility: Centre des maladies respiratoires et allergiques - Les Acacias Briançon, France
Sub-Investigator: Yasmina Bouazdia, Dr
Facility: CH de Morlaix Morlaix, France
Sub-Investigator: Catherine LE BER-MOY, MD
Sub-Investigator: Patricia Le Mevel, MD
Interventions
Device: neuromuscular electrical stimulation
quadriceps strenghthening with neuromuscular electrical stimulation (medical device)
Device: cycle ergometer training
quadriceps strenghthening with cycle ergometer training
Other: Conventional pulmonary rehabilitation
excercise training on treadmill
Information Source
ID Number: ESNM (RB 15.058)
NCT Identifier: NCT02656667
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT02656667
ClinicalTrials.gov processed this data on September 29, 2016
by this site. Please see the full source link above for retrieving further details from the government database.