Tolerance to Electrostimulation in COPD Patients - Full Text View

Sponsored by:	Laval University
Information provided by:	Laval University
ClinicalTrials.gov Identifier:	NCT00809120

Purpose

The study was designed to test the following hypothesis

Patients with high cardio-respiratory response to electrostimulation (ES), high perception of pain during ES and high ES-induced muscle fatigue, have low tolerance to ES (more difficulties to increase intensity during training).

Condition	Intervention
COPD	Device: Neuromuscular Electrical stimulator

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Investigation of Clinical Tolerance, Cardio-Respiratory Response and Muscle Fatigue During Electrostimulation

Further study details as provided by Laval University:

Primary Outcome Measures:

Tolerance to ES = Change in ES intensity between session 2 and 3 (delta intensity) [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cardiorespiratory response during ES [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Muscle fatigue after ES [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Body composition [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Perception of pain at session 2 (symptoms on Visual Analogic Scale) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Plasmatic proteins after ES [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment:	21
Study Start Date:	December 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

50Hz 30 min 7 sessions

Detailed Description:

Background: Muscle electrostimulation (ES) appears as a promising alternative to general physical reconditioning in advanced COPD and its feasibility has been confirmed in this population. However, patients are not equal in tolerance to ES. Certain patients are not able to increase ES intensity during training, limiting its benefits. Furthermore, little is known about the effect of one ES training session on cardio-respiratory response, muscle fatigue and systemic inflammation in COPD patients.

Objective: To evaluate the tolerance to ES in COPD patients and to identify the physiological parameters involved in ES tolerance.

Method: We propose to conduct a prospective study including 21 COPD patients of different pulmonary severity (7 in each group of GOLD II, III and IV).

Patients will be evaluated 3 times: at day 1, day 2 and day 9. In the first session, patients will be initiated to ES and evaluated in walking distance.

In the second session, patients will become autonomous with ES and they will be evaluated in muscle strength and body composition. In the third session, cardio-respiratory measurements will be performed during ES and patients will be evaluated in muscle strength and systemic inflammation (blood sampling) before and after ES. Between the 2d and the 3d sessions, patients will have to perform 5 ES sessions at home (from day 3 to day 8). Tolerance (symptoms assessed with visual analogical scale (VAS)) and intensity of ES will be measured during each ES session.

Planning analysis: The main outcome will be the change in ES intensity between session 2 and 3 (delta intensity). The other end-points will be minute ventilation, heart rate, VO2 and SaO2 during ES, but also change in ES tolerance (VAS) during ES at equal ES intensity, leg muscle fatigue after ES, body composition and changes in plasmatic proteins after ES. Simple and multiple regressions analysis will be done between delta intensity and

1/cardio-respiratory response during ES, 2/muscle fatigue after ES, 3/body composition, 4/perception of pain at session 2 (VAS), 5/changes in plasmatic proteins after ES.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is diagnosed with COPD.
40 years-old and older
Currently or previously smoking with a smoking history of at least 10 pack-years
Subject understands and is able to read and write French or English

Exclusion Criteria:

absence of neuromuscular pathology
absence of vascular pathology
absence of dermatosis on legs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809120

Contacts

Contact: François Maltais, MD	4186564747	Francois.maltais@med.ulaval.ca
Contact: Isabelle Vivodtzev, PhD	4186568711 ext 3085	Isabelle.vivodtzev@crhl.ulaval.ca

Locations

Canada, Quebec
Hôpital Laval
Quebec City, Quebec, Canada, G1V4G5

Sponsors and Collaborators

Laval University

More Information

No publications provided

Responsible Party:	Laval University ( Dr François Maltais )
Study ID Numbers:	CER20357
Study First Received:	December 16, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00809120 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Laval University:

Electrostimulation
COPD
Tolerance
Muscle fatigue
Cardio-respiratory response

Study placed in the following topic categories:

Lung Diseases, Obstructive
Fatigue
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009