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

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ClinicalTrials.gov Identifier: NCT02656667
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
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 .

Condition or disease Intervention/treatment Phase
COPD Device: neuromuscular electrical stimulation Device: cycle ergometer training Other: Conventional pulmonary rehabilitation Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program
Actual Study Start Date : June 8, 2016
Actual Primary Completion Date : March 21, 2019
Actual Study Completion Date : March 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: neuromuscular electrical stimulation
conventional pulmonary rehabilitation including exercise training on treadmill and neuromuscular electrical stimulation with a medical device for quadriceps muscle strengthening
Device: neuromuscular electrical stimulation
quadriceps strenghthening with neuromuscular electrical stimulation (medical device)

Other: Conventional pulmonary rehabilitation
excercise training on treadmill

Experimental: cycle ergometer training
conventional pulmonary rehabilitation including exercise training on treadmill and quadriceps strenghthening on cycle-ergometer
Device: cycle ergometer training
quadriceps strenghthening with cycle ergometer training

Other: Conventional pulmonary rehabilitation
excercise training on treadmill




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656667


Locations
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France
Centre des maladies respiratoires et allergiques - Les Acacias
Briançon, France, 05107
CH de Morlaix
Morlaix, France, 29672
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Francis Couturaud, MD, PhD University Hospital, Brest

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 22116795
Vivodtzev I, Debigaré R, Gagnon P, and al. Vivodtzev I, Debigaré R, Gagnon P, Mainguy V, Saey D, Dubé A, Paré MÈ, Bélanger M, Maltais F. Functional and muscular effects of neuromuscular electrical stimulation in patients with severe COPD: a randomized clinical trial. Chest. 2012 Mar;141(3):716-25.
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 24418570
Vieira PJ, Chiappa AM, Cipriano G Jr, Umpierre D, Arena R, Chiappa GR. Neuromuscular electrical stimulation improves clinical and physiological function in COPD patients.Respir Med. 2014 Apr;108(4):609-20.
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 23440837
Maddocks M, Gao W, Higginson IJ, Wilcock A.Neuromuscular electrical stimulation for muscle weakness in adults with advanced disease. Cochrane Database Syst Rev. 2013 Jan 31;1.
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 16806873
Ozalevli S, Ozden A, Itil O, Akkoclu A. Comparison of the Sit-to-Stand Test with 6 min walk test in patients with chronic obstructive pulmonary disease. Respir Med 2007;101(2):286-93.

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02656667     History of Changes
Other Study ID Numbers: ESNM (RB 15.058)
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Brest:
COPD pulmonary rehabilitation
neuromuscular electrical stimulation
sit to stand test COPD
quadriceps strengthening