Quadricipital Electrical Stimulation in COPD Patients Rehabilitation (Reha-Res)

University Hospital, Rouen

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: pulmonary rehabilitation; Device: group 2 : quadricipital electrical stimulation; Device: muscular electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02171377

2009/091/HP

2009-A00665-52 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Group 2 : quadricipital electrical stimulation

Experimental group

Description:

stimulation in addition to rehabilitation (30 min bilateral quadricipital electrical stimulation pd, 5 days per week, 8 weeks)

Treatment:

Device: muscular electrical stimulation

Device: group 2 : quadricipital electrical stimulation

Group 1 : Pulmonary rehabilitation

Active Comparator group

Description:

Pulmonary rehabilitation 3 to 5 times per week, 8 weeks

Treatment:

Other: pulmonary rehabilitation

Other: pulmonary rehabilitation