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

NCT ID: NCT02656667

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-08
• Study Completion Date: 2019-03-21

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 .

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

neuromuscular electrical stimulation

conventional pulmonary rehabilitation including exercise training on treadmill and neuromuscular electrical stimulation with a medical device for quadriceps muscle strengthening

Group Type: EXPERIMENTAL

neuromuscular electrical stimulation

Intervention Type: DEVICE

quadriceps strenghthening with neuromuscular electrical stimulation (medical device)

Conventional pulmonary rehabilitation

Intervention Type: OTHER

excercise training on treadmill

cycle ergometer training

conventional pulmonary rehabilitation including exercise training on treadmill and quadriceps strenghthening on cycle-ergometer

Group Type: EXPERIMENTAL

cycle ergometer training

Intervention Type: DEVICE

quadriceps strenghthening with cycle ergometer training

Conventional pulmonary rehabilitation

Intervention Type: OTHER

excercise training on treadmill

Interventions

neuromuscular electrical stimulation

quadriceps strenghthening with neuromuscular electrical stimulation (medical device)

Intervention Type: DEVICE

cycle ergometer training

quadriceps strenghthening with cycle ergometer training

Intervention Type: DEVICE

Conventional pulmonary rehabilitation

excercise training on treadmill

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis Couturaud, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Brest

Locations

Centre des maladies respiratoires et allergiques - Les Acacias

Briançon, France, France

CH de Morlaix

Morlaix, France, France

Countries

France

References

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.

Reference Type: RESULT

PMID: 35404157 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

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.

View Document

Document Type: Clinical Study Report

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.

View Document

Document Type: Clinical Study Report

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.

View Document

Document Type: Clinical Study Report

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.

View Document

Other Identifiers

ESNM (RB 15.058)

Identifier Type: -

Identifier Source: org_study_id