Tolerance to Electrostimulation in COPD Patients (TOES)

June 9, 2010 updated by: Laval University

Investigation of Clinical Tolerance, Cardio-respiratory Response and Muscle Fatigue During Electrostimulation

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).

Study Overview

Status

Completed

Conditions

COPD

Intervention / Treatment

Device: Neuromuscular Electrical stimulator (Cefar rehab 4 pro)

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Quebec
  - Quebec City, Quebec, Canada, G1V4G5
    - Hopital Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Screening
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tolerance to ES = Change in ES intensity between session 2 and 3 (delta intensity) Time Frame: 1 week	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Cardiorespiratory response during ES Time Frame: 1 week	1 week
Muscle fatigue after ES Time Frame: 1 week	1 week
Body composition Time Frame: 1 week	1 week
Perception of pain at session 2 (symptoms on Visual Analogic Scale) Time Frame: 1 week	1 week
Plasmatic proteins after ES Time Frame: 1 week	1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Vivodtzev I, Rivard B, Gagnon P, Mainguy V, Dube A, Belanger M, Jean B, Maltais F. Tolerance and physiological correlates of neuromuscular electrical stimulation in COPD: a pilot study. PLoS One. 2014 May 9;9(5):e94850. doi: 10.1371/journal.pone.0094850. eCollection 2014.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)