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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
group 2 : quadricipital electrical stimulation
pulmonary rehabilitation
muscular electrical stimulation
pulmonary rehabilitation
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, electrical stimulation, Rehabilitation, exercise test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rouen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 2 : quadricipital electrical stimulation

Group 1 : Pulmonary rehabilitation

Arm Description

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

Pulmonary rehabilitation 3 to 5 times per week, 8 weeks

Outcomes

Primary Outcome Measures

6 minute walking distance

Secondary Outcome Measures

incremental cardio pulmonary exercise test
Aerobic capacity, maximal achieved work rate, ventilatory threshold

Full Information

First Posted
October 11, 2010
Last Updated
August 29, 2017
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT02171377
Brief Title
Quadricipital Electrical Stimulation in COPD Patients Rehabilitation
Acronym
Reha-Res
Official Title
Quadricipital Electrical Stimulation in COPD Patients Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, electrical stimulation, Rehabilitation, exercise test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 2 : quadricipital electrical stimulation
Arm Type
Experimental
Arm Description
stimulation in addition to rehabilitation (30 min bilateral quadricipital electrical stimulation pd, 5 days per week, 8 weeks)
Arm Title
Group 1 : Pulmonary rehabilitation
Arm Type
Active Comparator
Arm Description
Pulmonary rehabilitation 3 to 5 times per week, 8 weeks
Intervention Type
Device
Intervention Name(s)
group 2 : quadricipital electrical stimulation
Intervention Description
bilateral quadricipital electrical stimulation 5 sessions a week, (6 - 8 weeks)
Intervention Type
Other
Intervention Name(s)
pulmonary rehabilitation
Intervention Description
exercise training, 3 to 5 times per week, 8 weeks
Intervention Type
Device
Intervention Name(s)
muscular electrical stimulation
Other Intervention Name(s)
Mi-Theta-Pro device (Compex medical SA ; CH - 1024 Ecublens); reference 498000 ; serial number WB100000.
Intervention Description
Bilateral quadricipital electrical stimulation 30 min, 5 times per week, 8 weeks,in addition to pulmonary rehabilitation
Intervention Type
Other
Intervention Name(s)
pulmonary rehabilitation
Other Intervention Name(s)
exercise training
Intervention Description
exercise training, 45 min, 3 to 5 times per week, 8 weeks
Primary Outcome Measure Information:
Title
6 minute walking distance
Time Frame
From 6 to 8 weeks
Secondary Outcome Measure Information:
Title
incremental cardio pulmonary exercise test
Description
Aerobic capacity, maximal achieved work rate, ventilatory threshold
Time Frame
From 6 to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29457998
Citation
Bonnevie T, Gravier FE, Debeaumont D, Viacroze C, Muir JF, Cuvelier A, Netchitailo M, Roy AL, Quieffin J, Marques MH, Medrinal C, Dupuis J, Tardif C. Home-based Neuromuscular Electrical Stimulation as an Add-on to Pulmonary Rehabilitation Does Not Provide Further Benefits in Patients With Chronic Obstructive Pulmonary Disease: A Multicenter Randomized Trial. Arch Phys Med Rehabil. 2018 Aug;99(8):1462-1470. doi: 10.1016/j.apmr.2018.01.024. Epub 2018 Feb 16.
Results Reference
derived

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Quadricipital Electrical Stimulation in COPD Patients Rehabilitation

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