NCT02656667

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

June 8, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2019

Completed
Last Updated

December 3, 2025

Status Verified

April 1, 2019

Enrollment Period

2.8 years

First QC Date

January 6, 2016

Last Update Submit

November 26, 2025

Conditions

COPD

Keywords

COPD pulmonary rehabilitationneuromuscular electrical stimulationsit to stand test COPDquadriceps strengthening

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Maximal isometric voluntary quadriceps strength assessment

    21 - 4 days / +7 days

  • isometric voluntary quadriceps endurance assessment

    21 - 4 days / +7 days

  • assessment of exercise capacity

    21 - 4 days / +7 days

  • Quality of Life Assessment

    21 - 4 days / +7 days

  • Dyspnea Assessment with Borg scale

    21 - 4 days / +7 days

  • +3 more secondary outcomes

Study Arms (2)

neuromuscular electrical stimulation

EXPERIMENTAL

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

Device: neuromuscular electrical stimulationOther: Conventional pulmonary rehabilitation

cycle ergometer training

EXPERIMENTAL

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

Device: cycle ergometer trainingOther: Conventional pulmonary rehabilitation

Interventions

neuromuscular electrical stimulationDEVICE

quadriceps strenghthening with neuromuscular electrical stimulation (medical device)

neuromuscular electrical stimulation
cycle ergometer trainingDEVICE

quadriceps strenghthening with cycle ergometer training

cycle ergometer training
Conventional pulmonary rehabilitationOTHER

excercise training on treadmill

cycle ergometer trainingneuromuscular electrical stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre des maladies respiratoires et allergiques - Les Acacias

Briançon, France, 05107, France

Location

CH de Morlaix

Morlaix, France, 29672, France

Location

Related Publications (1)

  • 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.

    PMID: 35404157RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Francis Couturaud, MD, PhD

    University Hospital, Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 15, 2016

Study Start

June 8, 2016

Primary Completion

March 21, 2019

Study Completion

March 21, 2019

Last Updated

December 3, 2025

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Clinical Study Report (22116795)Access
Clinical Study Report (24418570)Access
Clinical Study Report (23440837)Access
Clinical Study Report (16806873)Access

Locations

FR(2)