Clinical trial NCT02656667: Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program
Official title: Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD pulmonary rehabilitation
neuromuscular electrical stimulation
sit to stand test COPD
quadriceps strengthening
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: functional capacity of the lower limb muscles
timeFrame: 21 - 4 days / +7 days
Secondary outcomes:
measure: Maximal isometric voluntary quadriceps strength assessment
timeFrame: 21 - 4 days / +7 days
measure: isometric voluntary quadriceps endurance assessment
timeFrame: 21 - 4 days / +7 days
measure: assessment of exercise capacity
timeFrame: 21 - 4 days / +7 days
measure: Quality of Life Assessment
timeFrame: 21 - 4 days / +7 days
measure: Dyspnea Assessment with Borg scale
timeFrame: 21 - 4 days / +7 days
measure: Dyspnea Assessment with MRC Scale
timeFrame: 21 - 4 days / +7 days
measure: Dyspnea Assessment with Dyspnea 12 questionnary
timeFrame: 21 - 4 days / +7 days
measure: Inspiratory capacity (in litres) by spirometry
timeFrame: 21 - 4 days / +7 days
Other outcomes:
Locations:
city: Briançon
country: France
facility: Centre des maladies respiratoires et allergiques - Les Acacias
city: Morlaix
country: France
facility: CH de Morlaix
Study officials:
affiliation: University Hospital, Brest
name: Francis Couturaud, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: