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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marthe Bélanger, Laval University
ClinicalTrials.gov Identifier:
NCT00874965
First received: April 2, 2009
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD)
 Device: Electrostimulation
Device: Sham stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:
  • Change in the strength of the quadriceps over the 6-week electrostimulation program. [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ventilation at iso-time during an endurance shuttle walkMuscle [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]
  • hypertrophying/atrophying pathways [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]
  • Muscle aerobic capacity: fibre-typing, oxydative enzymes, muscle capillarization [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: December 2006
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ES
Electrostimulation
 Device: Electrostimulation
50Hz; 0.4 ms; 30 min; 5 times / week
Placebo Comparator: Sham ES
Sham stimulation
 Device: Sham stimulation
30 min; 5 times / week

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.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874965

Locations
Canada, Quebec
Hôpital Laval
Quebec city, Quebec, Canada, G1V4G5
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: François Maltais, MD Laval University
  More Information

No publications provided by Laval University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marthe Bélanger, Professionnel de recherche, Laval University
ClinicalTrials.gov Identifier: NCT00874965     History of Changes
Other Study ID Numbers: CER20105
Study First Received: April 2, 2009
Last Updated: October 9, 2012
Health Authority: Canada: Health Canada

Keywords provided by Laval University:
Chronic Obstructive Pulmonary Disease (COPD)
Electrostimulation
Muscle function
Exercise ventilation
Anabolism/catabolism pathway

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013