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Electrostimulation, Skeletal Muscle Function, and Exercise Capacity in Chronic Obstructive Pulmonary Disease (COPD) (ESTIM)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Electrostimulation
Sham stimulation
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic Obstructive Pulmonary Disease (COPD), Electrostimulation, Muscle function, Exercise ventilation, Anabolism/catabolism pathway

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COPD
  • FEV1 < 60% predicted value and FEV1/ FVC < 70%
  • 6-minute walking distance < 400 m

Exclusion Criteria:

  • Patients suffering from cardiovascular, neurological, skeletal muscle, or any other condition that could alter their capacity to perform the exercise test
  • Patients taking systemic corticosteroids on a daily basis (patients having received systemic steroids for the treatment of up to two exacerbations in the preceding year and those on inhaled steroids will be allowed)
  • Patients with room air PaO2 < 60 mm Hg will be excluded.

Sites / Locations

  • Hôpital Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ES

Sham ES

Arm Description

Electrostimulation

Sham stimulation

Outcomes

Primary Outcome Measures

Change in the strength of the quadriceps over the 6-week electrostimulation program.

Secondary Outcome Measures

Ventilation at iso-time during an endurance shuttle walkMuscle
hypertrophying/atrophying pathways
Muscle aerobic capacity: fibre-typing, oxydative enzymes, muscle capillarization

Full Information

First Posted
April 2, 2009
Last Updated
October 9, 2012
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT00874965
Brief Title
Electrostimulation, Skeletal Muscle Function, and Exercise Capacity in Chronic Obstructive Pulmonary Disease (COPD)
Acronym
ESTIM
Official Title
Study of the Benefits of Lower Limb Electrostimulation Training on Muscular Parameters and Minute Ventilation During Exercise in Severe and Deconditioned COPD Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study was designed to test the following hypothesis: The benefit of electrostimulation training will be greater than sham stimulation training in term of muscle strength and mass (muscle hypertrophy), exercise tolerance, reduction of ventilation during exercise and quality of life in COPD patients
Detailed Description
Background: Because it has little impact on ventilatory requirements and dyspnea, muscle electrostimulation appears as a promising alternative to general physical reconditioning in advanced COPD and its feasibility has been confirmed in this population. However, the physiological mechanisms underlying the proposed benefits of electrostimulation training have not been explored. Objective: To evaluate in COPD patients the physiological mechanisms of changes in exercise tolerance after electrostimulation training. Method: We propose to conduct a controlled, randomized and double blind clinical trial comparing the efficacy of muscle electrostimulation training of the lower limbs to sham training in 24 patients with COPD. Patients are included in either 6 weeks of electrostimulation training (active treatment group) or 6 weeks of sham electrostimulation. Before and after training, patients perform endurance shuttle walking test, muscle function testing, muscle biopsy, blood sampling and health-related quality of life questionnaire. Planning analysis: The main outcome will be change in the strength of the quadriceps over the 6-week electrostimulation program. The other end-points will be mid-thigh and calf muscle cross-sectional area, lower limb muscle endurance, ventilation, dyspnea, leg fatigue, operational lung volumes at iso-time and walking time during an endurance shuttle walk, muscle hypertrophying/atrophying pathways and muscle aerobic capacity. For each group, pre- and post-training comparisons will be made using a repeated measures design. The magnitude of the pre- and post-training changes will also compared between both groups with a two-way ANOVA (group, training effect) with repeated measures on the second factor (training effect). A p value < 0.05 will be considered statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic Obstructive Pulmonary Disease (COPD), Electrostimulation, Muscle function, Exercise ventilation, Anabolism/catabolism pathway

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ES
Arm Type
Active Comparator
Arm Description
Electrostimulation
Arm Title
Sham ES
Arm Type
Placebo Comparator
Arm Description
Sham stimulation
Intervention Type
Device
Intervention Name(s)
Electrostimulation
Intervention Description
50Hz; 0.4 ms; 30 min; 5 times / week
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
30 min; 5 times / week
Primary Outcome Measure Information:
Title
Change in the strength of the quadriceps over the 6-week electrostimulation program.
Time Frame
6 to 8 weeks
Secondary Outcome Measure Information:
Title
Ventilation at iso-time during an endurance shuttle walkMuscle
Time Frame
6 to 8 weeks
Title
hypertrophying/atrophying pathways
Time Frame
6 to 8 weeks
Title
Muscle aerobic capacity: fibre-typing, oxydative enzymes, muscle capillarization
Time Frame
6 to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COPD FEV1 < 60% predicted value and FEV1/ FVC < 70% 6-minute walking distance < 400 m Exclusion Criteria: Patients suffering from cardiovascular, neurological, skeletal muscle, or any other condition that could alter their capacity to perform the exercise test Patients taking systemic corticosteroids on a daily basis (patients having received systemic steroids for the treatment of up to two exacerbations in the preceding year and those on inhaled steroids will be allowed) Patients with room air PaO2 < 60 mm Hg will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Maltais, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Laval
City
Quebec city
State/Province
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22116795
Citation
Vivodtzev I, Debigare R, Gagnon P, Mainguy V, Saey D, Dube A, Pare ME, Belanger M, Maltais F. Functional and muscular effects of neuromuscular electrical stimulation in patients with severe COPD: a randomized clinical trial. Chest. 2012 Mar;141(3):716-725. doi: 10.1378/chest.11-0839. Epub 2011 Nov 23.
Results Reference
derived

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Electrostimulation, Skeletal Muscle Function, and Exercise Capacity in Chronic Obstructive Pulmonary Disease (COPD)

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