Quadricipital Electrical Stimulation in COPD Patients Rehabilitation

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: muscular electrical stimulation; Other: pulmonary rehabilitation

• Registration Number: NCT02171377
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2010-10
• Study First Submitted: 2010-10-11
• Study Completion: 2013-12
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-24
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 : quadricipital electrical stimulation	muscular electrical stimulation	stimulation in addition to rehabilitation (30 min bilateral quadricipital electrical stimulation pd, 5 days per week, 8 weeks)
Group 1 : Pulmonary rehabilitation	pulmonary rehabilitation	Pulmonary rehabilitation 3 to 5 times per week, 8 weeks

Primary Outcome Measures

Name	Time	Method
6 minute walking distance	From 6 to 8 weeks

Secondary Outcome Measures

Name	Time	Method
incremental cardio pulmonary exercise test	From 6 to 8 weeks	Aerobic capacity, maximal achieved work rate, ventilatory threshold

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France