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

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 .

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Device: neuromuscular electrical stimulation; Other: Conventional pulmonary rehabilitation; Device: cycle ergometer training

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • France
    • Briançon, France, France, 05107
      • Centre des maladies respiratoires et allergiques - Les Acacias
    • Morlaix, France, France, 29672
      • CH de Morlaix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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	Other: Conventional pulmonary rehabilitation; excercise training on treadmill; Device: cycle ergometer training; quadriceps strenghthening with cycle ergometer training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Francis Couturaud, MD, PhD, University Hospital, Brest

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2016
• Primary Completion (Actual): March 21, 2019
• Study Completion (Actual): March 21, 2019

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (Estimated): January 15, 2016

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: neuromuscular electrical stimulation; COPD pulmonary rehabilitation; sit to stand test COPD; quadriceps strengthening
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ESNM (RB 15.058)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Clinical Study Report
   Information identifier: 22116795
   Information comments: 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.
2. Clinical Study Report
   Information identifier: 24418570
   Information comments: 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.
3. Clinical Study Report
   Information identifier: 23440837
   Information comments: 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.
4. Clinical Study Report
   Information identifier: 16806873
   Information comments: 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.