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

COPD Clinical Trial

— ESNM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656667
• Other study ID #: ESNM (RB 15.058)
• Status: Completed
• Phase: N/A
• Start date: June 8, 2016
• Est. completion date: March 21, 2019

Study information

• Verified date: April 2019
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 21, 2019
• Est. primary completion date: March 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• neuromuscular electrical stimulation
quadriceps strenghthening with neuromuscular electrical stimulation (medical device)
• cycle ergometer training
quadriceps strenghthening with cycle ergometer training

Other:
• Conventional pulmonary rehabilitation
excercise training on treadmill

Locations

Country	Name	City	State
France	Centre des maladies respiratoires et allergiques - Les Acacias	Briançon
France	CH de Morlaix	Morlaix

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional capacity of the lower limb muscles	Measure of the functional capacity of the lower limb muscles with the "1 minute Sit To Stand Test "	21 - 4 days / +7 days
Secondary	Maximal isometric voluntary quadriceps strength assessment	Quadriceps strength assessment with handheld dynamometer	21 - 4 days / +7 days
Secondary	isometric voluntary quadriceps endurance assessment	Measure of isometric voluntary quadriceps endurance assessment with handheld dynamometer	21 - 4 days / +7 days
Secondary	assessment of exercise capacity	Six minute walking test for assessing exercise capacity	21 - 4 days / +7 days
Secondary	Quality of Life Assessment	COPD assessment test for assessing quality of life	21 - 4 days / +7 days
Secondary	Dyspnea Assessment with Borg scale	Measure of dyspnea with Borg scale at the end of the six minute walking test	21 - 4 days / +7 days
Secondary	Dyspnea Assessment with MRC Scale	Measure of dyspnea with Medical Research Council Dyspnea Scale	21 - 4 days / +7 days
Secondary	Dyspnea Assessment with Dyspnea 12 questionnary	Measure of dyspnea with Dyspnea 12 questionnary	21 - 4 days / +7 days
Secondary	Inspiratory capacity (in litres) by spirometry	Measure of inspiratory capacity (in litres) by spirometry	21 - 4 days / +7 days