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

August 29, 2017 updated by: University Hospital, Rouen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76031
        • Rouen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 2 : quadricipital electrical stimulation
stimulation in addition to rehabilitation (30 min bilateral quadricipital electrical stimulation pd, 5 days per week, 8 weeks)
Device: group 2 : quadricipital electrical stimulation
bilateral quadricipital electrical stimulation 5 sessions a week, (6 - 8 weeks)
Device: muscular electrical stimulation
Bilateral quadricipital electrical stimulation 30 min, 5 times per week, 8 weeks,in addition to pulmonary rehabilitation
Other Names:
  • Mi-Theta-Pro device (Compex medical SA ; CH - 1024 Ecublens); reference 498000 ; serial number WB100000.
Active Comparator: Group 1 : Pulmonary rehabilitation
Pulmonary rehabilitation 3 to 5 times per week, 8 weeks
Other: pulmonary rehabilitation
exercise training, 3 to 5 times per week, 8 weeks
Other: pulmonary rehabilitation
exercise training, 45 min, 3 to 5 times per week, 8 weeks
Other Names:
  • exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6 minute walking distance
Time Frame: From 6 to 8 weeks
From 6 to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incremental cardio pulmonary exercise test
Time Frame: From 6 to 8 weeks
Aerobic capacity, maximal achieved work rate, ventilatory threshold
From 6 to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 11, 2010

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/091/HP
  • 2009-A00665-52 (Registry Identifier: AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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