Clinical trial NCT02171377: Quadricipital Electrical Stimulation in COPD Patients Rehabilitation
Official title: Quadricipital Electrical Stimulation in COPD Patients Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
electrical stimulation
Rehabilitation
exercise test
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Quadricipital electrical stimulation added to respiratory rehabilitation in COPD patients.

Quadricipital electrical stimulation (ES) in chronic obstructive pulmonary disease (COPD) patients has been demonstrated to improve both dyspnea and physical status. The aim of our study is to demonstrate that ES added to respiratory rehabilitation program induces a greater improvement on exercise tolerance in such patients.

Design : 160 patients with severe COPD will be randomly assigned to 2 groups : either rehabilitation program (group 1), either ES and rehabilitation program (group 2). In both groups, rehabilitation program comprises endurance training, 18 - 24 sessions (6 - 8 weeks), health education, global muscular strengthening. In group 2, bilateral quadricipital electrical stimulation 30 min sessions is added 5 days / week.

Subjects : COPD patients with FEV1 \< 60% pred, FEV1/VC \< 70%, and TLC \> 80%, with dyspnea, in stable conditions, and 18 \> BMI \< 35 kg/m² .

Intervention : 6 min walking distance, incremental exercise test data (aerobic capacity, work rate, ventilatory threshold), physical activity with activity monitor, health related quality of life will be determined before and after training.

Abbreviations : FEV1 = forced expiratory volume in 1 sec; VC = vital capacity; TLC = total lung capacity; BMI = body mass index.


Eligibility criteria: Inclusion Criteria:

* Subjects : COPD patients with FEV1 \< 60% pred, FEV1/VC \< 70%, and TLC \> 80%, with dyspnea, in stable conditions, and 18 \> BMI \< 35 kg/m²

Exclusion Criteria:

* BMI 18 \< or \> 35 kg/m²
* Pregnant women
* peripheral neuropathy
* cardio respiratory incremental test contra-indication
* evolutive cancer
* cardiac or cerebral pace maker, implanted cardio defibrillator
* no informed consent given

Primary outcomes:
measure: 6 minute walking distance
timeFrame: From 6 to 8 weeks
Secondary outcomes:
measure: incremental cardio pulmonary exercise test
timeFrame: From 6 to 8 weeks
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
References:
citation: Bonnevie T, Gravier FE, Debeaumont D, Viacroze C, Muir JF, Cuvelier A, Netchitailo M, Roy AL, Quieffin J, Marques MH, Medrinal C, Dupuis J, Tardif C. Home-based Neuromuscular Electrical Stimulation as an Add-on to Pulmonary Rehabilitation Does Not Provide Further Benefits in Patients With Chronic Obstructive Pulmonary Disease: A Multicenter Randomized Trial. Arch Phys Med Rehabil. 2018 Aug;99(8):1462-1470. doi: 10.1016/j.apmr.2018.01.024. Epub 2018 Feb 16.