Tolerance to Electrostimulation in COPD Patients

COPD Clinical Trial

— TOES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809120
• Other study ID #: CER20357
• Status: Completed
• Phase: N/A
• First received: December 16, 2008
• Last updated: June 9, 2010
• Start date: December 2008
• Est. completion date: August 2009

Study information

• Verified date: September 2008
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• Neuromuscular Electrical stimulator (Cefar rehab 4 pro)
50Hz 30 min 7 sessions

Locations

Country	Name	City	State
Canada	Hôpital Laval	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance to ES = Change in ES intensity between session 2 and 3 (delta intensity)		1 week	No
Secondary	Cardiorespiratory response during ES		1 week	No
Secondary	Muscle fatigue after ES		1 week	No
Secondary	Body composition		1 week	No
Secondary	Perception of pain at session 2 (symptoms on Visual Analogic Scale)		1 week	No
Secondary	Plasmatic proteins after ES		1 week	No