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Completed

NCT Number: NCT00809120

Tolerance to Electrostimulation in COPD Patients

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).

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Laval

Québec, Quebec, G1V4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular Electrical stimulator (Cefar rehab 4 pro)

Device

50Hz 30 min 7 sessions

Other names: NMES

Primary outcomes

  1. Tolerance to ES = Change in ES intensity between session 2 and 3 (delta intensity)

    Time frame: 1 week

Secondary outcomes

  1. Cardiorespiratory response during ES

    Time frame: 1 week

  2. Muscle fatigue after ES

    Time frame: 1 week

  3. Body composition

    Time frame: 1 week

  4. Perception of pain at session 2 (symptoms on Visual Analogic Scale)

    Time frame: 1 week

  5. Plasmatic proteins after ES

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Acronym: TOES

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 17, 2008
Registry last updated
Jun 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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