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

Study of the Benefits of Lower Limb Electrostimulation Training on Muscular Parameters and Minute Ventilation During Exercise in Severe and Deconditioned COPD Patients.

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: Electrostimulation; Device: Sham stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Quebec city, Quebec, Canada, G1V4G5
      • Hopital Laval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the strength of the quadriceps over the 6-week electrostimulation program.	6 to 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Ventilation at iso-time during an endurance shuttle walkMuscle	6 to 8 weeks
hypertrophying/atrophying pathways	6 to 8 weeks
Muscle aerobic capacity: fibre-typing, oxydative enzymes, muscle capillarization	6 to 8 weeks

Collaborators and Investigators

• Sponsor: Laval University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: April 2, 2009
• First Submitted That Met QC Criteria: April 2, 2009
• First Posted (Estimate): April 3, 2009

Study Record Updates

• Last Update Posted (Estimate): October 10, 2012
• Last Update Submitted That Met QC Criteria: October 9, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Muscle function; Chronic Obstructive Pulmonary Disease (COPD); Electrostimulation; Exercise ventilation; Anabolism/catabolism pathway
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CER20105