Quadricipital Electrical Stimulation in COPD Patients Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 2 : quadricipital electrical stimulation

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

Group Type EXPERIMENTAL

group 2 : quadricipital electrical stimulation

Intervention Type DEVICE

bilateral quadricipital electrical stimulation 5 sessions a week, (6 - 8 weeks)

muscular electrical stimulation

Intervention Type DEVICE

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

Group 1 : Pulmonary rehabilitation

Pulmonary rehabilitation 3 to 5 times per week, 8 weeks

Group Type ACTIVE_COMPARATOR

pulmonary rehabilitation

Intervention Type OTHER

exercise training, 3 to 5 times per week, 8 weeks

pulmonary rehabilitation

Intervention Type OTHER

exercise training, 45 min, 3 to 5 times per week, 8 weeks

Interventions

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group 2 : quadricipital electrical stimulation

bilateral quadricipital electrical stimulation 5 sessions a week, (6 - 8 weeks)

Intervention Type DEVICE

pulmonary rehabilitation

exercise training, 3 to 5 times per week, 8 weeks

Intervention Type OTHER

muscular electrical stimulation

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

Intervention Type DEVICE

pulmonary rehabilitation

exercise training, 45 min, 3 to 5 times per week, 8 weeks

Intervention Type OTHER

Other Intervention Names

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Mi-Theta-Pro device (Compex medical SA ; CH - 1024 Ecublens); reference 498000 ; serial number WB100000. exercise training

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No