Quadricipital Electrical Stimulation in COPD Patients Rehabilitation

Chronic Obstructive Pulmonary Disease Clinical Trial

— Reha-Res  

Official title:

Quadricipital Electrical Stimulation in COPD Patients Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02171377
• Other study ID #: 2009/091/HP
• Secondary ID: 2009-A00665-52
• Status: Completed
• Phase: N/A
• First received: October 11, 2010
• Last updated: August 29, 2017
• Start date: August 2010
• Est. completion date: December 2013

Study information

• Verified date: August 2017
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2013
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• group 2 : quadricipital electrical stimulation
bilateral quadricipital electrical stimulation 5 sessions a week, (6 - 8 weeks)

Other:
• pulmonary rehabilitation
exercise training, 3 to 5 times per week, 8 weeks

Device:
• muscular electrical stimulation
Bilateral quadricipital electrical stimulation 30 min, 5 times per week, 8 weeks,in addition to pulmonary rehabilitation

Other:
• pulmonary rehabilitation
exercise training, 45 min, 3 to 5 times per week, 8 weeks

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walking distance		From 6 to 8 weeks
Secondary	incremental cardio pulmonary exercise test	Aerobic capacity, maximal achieved work rate, ventilatory threshold	From 6 to 8 weeks