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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: COPD

Treatments: Device: neuromuscular electrical stimulation; Other: Conventional pulmonary rehabilitation; Device: cycle ergometer training

Study type: Interventional

Funder types: Other

Identifiers

NCT02656667

ESNM (RB 15.058)

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

neuromuscular electrical stimulation

Experimental group

Description:

conventional pulmonary rehabilitation including exercise training on treadmill and neuromuscular electrical stimulation with a medical device for quadriceps muscle strengthening

Treatment:

Other: Conventional pulmonary rehabilitation

Device: neuromuscular electrical stimulation

cycle ergometer training

Experimental group

Description:

conventional pulmonary rehabilitation including exercise training on treadmill and quadriceps strenghthening on cycle-ergometer

Treatment:

Other: Conventional pulmonary rehabilitation

Device: cycle ergometer training