Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program

Not Applicable

Completed

• Conditions: COPD
• Interventions: Device: neuromuscular electrical stimulation; Device: cycle ergometer training; Other: Conventional pulmonary rehabilitation

• Registration Number: NCT02656667
• Lead Sponsor: University Hospital, Brest

Brief Summary

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 Timeline

• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-15
• Study Start: 2016-06-08
• Primary Completion: 2019-03-21
• Study Completion: 2019-03-21
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Patients with COPD stage 3 or 4, with BODE index ≥ 5
• Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix or in the center "Les Acacias" of briançon, with a 3 at 4 weeks pulmonary rehabilitation course;

Exclusion Criteria

• FEV ≥ 50%
• Pneumonectomy, Lobectomy less than 6 months
• Contraindications to muscle electrostimulation quadriceps
• Absence of written consent
• Inability to follow the respiratory rehabilitation program in its entirety
• People equipped with electronic devices such as pacemakers and intracardiac defibrillators
• Skin lesions and infectious foci on the electrode placement area.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
neuromuscular electrical stimulation	neuromuscular electrical stimulation	conventional pulmonary rehabilitation including exercise training on treadmill and neuromuscular electrical stimulation with a medical device for quadriceps muscle strengthening
cycle ergometer training	cycle ergometer training	conventional pulmonary rehabilitation including exercise training on treadmill and quadriceps strenghthening on cycle-ergometer
neuromuscular electrical stimulation	Conventional pulmonary rehabilitation	conventional pulmonary rehabilitation including exercise training on treadmill and neuromuscular electrical stimulation with a medical device for quadriceps muscle strengthening
cycle ergometer training	Conventional pulmonary rehabilitation	conventional pulmonary rehabilitation including exercise training on treadmill and quadriceps strenghthening on cycle-ergometer

Primary Outcome Measures

Name	Time	Method
functional capacity of the lower limb muscles	21 - 4 days / +7 days	Measure of the functional capacity of the lower limb muscles with the "1 minute Sit To Stand Test "

Secondary Outcome Measures

Name	Time	Method
isometric voluntary quadriceps endurance assessment	21 - 4 days / +7 days	Measure of isometric voluntary quadriceps endurance assessment with handheld dynamometer
Maximal isometric voluntary quadriceps strength assessment	21 - 4 days / +7 days	Quadriceps strength assessment with handheld dynamometer
Dyspnea Assessment with MRC Scale	21 - 4 days / +7 days	Measure of dyspnea with Medical Research Council Dyspnea Scale
assessment of exercise capacity	21 - 4 days / +7 days	Six minute walking test for assessing exercise capacity
Quality of Life Assessment	21 - 4 days / +7 days	COPD assessment test for assessing quality of life
Dyspnea Assessment with Borg scale	21 - 4 days / +7 days	Measure of dyspnea with Borg scale at the end of the six minute walking test
Dyspnea Assessment with Dyspnea 12 questionnary	21 - 4 days / +7 days	Measure of dyspnea with Dyspnea 12 questionnary
Inspiratory capacity (in litres) by spirometry	21 - 4 days / +7 days	Measure of inspiratory capacity (in litres) by spirometry

Trial Locations

Locations (2)

Centre des maladies respiratoires et allergiques - Les Acacias; 🇫🇷 Briançon, France

CH de Morlaix; 🇫🇷 Morlaix, France