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.
1 other identifier
interventional
23
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 2, 2009
CompletedFirst Posted
Study publicly available on registry
April 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedOctober 10, 2012
October 1, 2012
2.4 years
April 2, 2009
October 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the strength of the quadriceps over the 6-week electrostimulation program.
6 to 8 weeks
Secondary Outcomes (3)
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
Study Arms (2)
ES
ACTIVE COMPARATORElectrostimulation
Sham ES
PLACEBO COMPARATORSham stimulation
Interventions
Eligibility Criteria
You may qualify if:
- COPD
- FEV1 \< 60% predicted value and FEV1/ FVC \< 70%
- minute walking distance \< 400 m
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
Study Sites (1)
Hôpital Laval
Québec, Quebec, G1V4G5, Canada
Related Publications (1)
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.
PMID: 22116795DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François Maltais, MD
Laval University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professionnel de recherche
Study Record Dates
First Submitted
April 2, 2009
First Posted
April 3, 2009
Study Start
December 1, 2006
Primary Completion
May 1, 2009
Study Completion
June 1, 2009
Last Updated
October 10, 2012
Record last verified: 2012-10