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Completed

NCT Number: NCT02656667

Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program

The aim of this study is to evaluate the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer as part of pulmonary rehabilitation program , in patients with severe or very severe COPD , according to GOLD with BODE index ≥ 5 .

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre des maladies respiratoires et allergiques - Les Acacias, Briançon, France

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About this study

It's a prospective ,multicentre,randomised, single-blind study which compare the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer training as part of pulmonary rehabilitation program.

The program lasts from 3 to 4 weeks. 102 patients will included, diagnosed with COPD stages GOLD III and IV, and BODE index ≥ 5.

The commun program: training protocol performed on treadmill,quadriceps resistance training,patient therapeutic education,collective gymnastics,relaxation, session psychological care, smoking cessation program and nutritional management if necessary.

The primary criterion is the one minute sit to stand test.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with COPD stage 3 or 4, with BODE index ≥ 5
  • Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix or in the center "Les Acacias" of briançon, with a 3 at 4 weeks pulmonary rehabilitation course;

Exclusion criteria

  • FEV ≥ 50%
  • Pneumonectomy, Lobectomy less than 6 months
  • Contraindications to muscle electrostimulation quadriceps
  • Absence of written consent
  • Inability to follow the respiratory rehabilitation program in its entirety
  • People equipped with electronic devices such as pacemakers and intracardiac defibrillators
  • Skin lesions and infectious foci on the electrode placement area.

Treatment and study plan

Neuromuscular Electrical Stimulation

Device

quadriceps strenghthening with neuromuscular electrical stimulation (medical device)

cycle ergometer training

Device

quadriceps strenghthening with cycle ergometer training

Conventional pulmonary rehabilitation

Other

excercise training on treadmill

Primary outcomes

  1. functional capacity of the lower limb muscles

    Time frame: 21 - 4 days / +7 days

    Measure of the functional capacity of the lower limb muscles with the "1 minute Sit To Stand Test "

Secondary outcomes

  1. Maximal isometric voluntary quadriceps strength assessment

    Time frame: 21 - 4 days / +7 days

    Quadriceps strength assessment with handheld dynamometer

  2. isometric voluntary quadriceps endurance assessment

    Time frame: 21 - 4 days / +7 days

    Measure of isometric voluntary quadriceps endurance assessment with handheld dynamometer

  3. assessment of exercise capacity

    Time frame: 21 - 4 days / +7 days

    Six minute walking test for assessing exercise capacity

  4. Quality of Life Assessment

    Time frame: 21 - 4 days / +7 days

    COPD assessment test for assessing quality of life

  5. Dyspnea Assessment with Borg scale

    Time frame: 21 - 4 days / +7 days

    Measure of dyspnea with Borg scale at the end of the six minute walking test

  6. Dyspnea Assessment with MRC Scale

    Time frame: 21 - 4 days / +7 days

    Measure of dyspnea with Medical Research Council Dyspnea Scale

  7. Dyspnea Assessment with Dyspnea 12 questionnary

    Time frame: 21 - 4 days / +7 days

    Measure of dyspnea with Dyspnea 12 questionnary

  8. Inspiratory capacity (in litres) by spirometry

    Time frame: 21 - 4 days / +7 days

    Measure of inspiratory capacity (in litres) by spirometry

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: ESNM

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 15, 2016
Registry last updated
Dec 3, 2025

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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