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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 .
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neuromuscular electrical stimulation | Experimental | conventional pulmonary rehabilitation including exercise training on treadmill and neuromuscular electrical stimulation with a medical device for quadriceps muscle strengthening |
|
| cycle ergometer training | Experimental | conventional pulmonary rehabilitation including exercise training on treadmill and quadriceps strenghthening on cycle-ergometer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neuromuscular electrical stimulation | Device | quadriceps strenghthening with neuromuscular electrical stimulation (medical device) |
|
| Measure | Description | Time Frame |
|---|---|---|
| functional capacity of the lower limb muscles | Measure of the functional capacity of the lower limb muscles with the "1 minute Sit To Stand Test " | 21 - 4 days / +7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal isometric voluntary quadriceps strength assessment | Quadriceps strength assessment with handheld dynamometer | 21 - 4 days / +7 days |
| isometric voluntary quadriceps endurance assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis Couturaud, MD, PhD | University Hospital, Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre des maladies respiratoires et allergiques - Les Acacias | Briançon | France | 05107 | France | ||
| CH de Morlaix |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35404157 | Result | Peran L, Beaumont M, Le Ber C, Le Mevel P, Berriet AC, Nowak E, Consigny M, Couturaud F. Effect of neuromuscular electrical stimulation on exercise capacity in patients with severe chronic obstructive pulmonary disease: A randomised controlled trial. Clin Rehabil. 2022 Aug;36(8):1072-1082. doi: 10.1177/02692155221091802. Epub 2022 Apr 11. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| 22116795 | Clinical Study Report | View IPD |
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| cycle ergometer training | Device | quadriceps strenghthening with cycle ergometer training |
|
| Conventional pulmonary rehabilitation | Other | excercise training on treadmill |
|
Measure of isometric voluntary quadriceps endurance assessment with handheld dynamometer
| 21 - 4 days / +7 days |
| assessment of exercise capacity | Six minute walking test for assessing exercise capacity | 21 - 4 days / +7 days |
| Quality of Life Assessment | COPD assessment test for assessing quality of life | 21 - 4 days / +7 days |
| Dyspnea Assessment with Borg scale | Measure of dyspnea with Borg scale at the end of the six minute walking test | 21 - 4 days / +7 days |
| Dyspnea Assessment with MRC Scale | Measure of dyspnea with Medical Research Council Dyspnea Scale | 21 - 4 days / +7 days |
| Dyspnea Assessment with Dyspnea 12 questionnary | Measure of dyspnea with Dyspnea 12 questionnary | 21 - 4 days / +7 days |
| Inspiratory capacity (in litres) by spirometry | Measure of inspiratory capacity (in litres) by spirometry | 21 - 4 days / +7 days |
| Morlaix |
| France |
| 29672 |
| France |
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. |
| 24418570 | Clinical Study Report | View IPD | 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. |
| 23440837 | Clinical Study Report | View IPD | 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. |
| 16806873 | Clinical Study Report | View IPD | 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. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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