Combined Neuromuscular Electrical Stimulation for Quadriceps and Triceps During Pulmonary Rehabilitation in COPD (COMBIELEC)

Interest of Adding Neuromuscular Electrical Stimulation for Quadriceps Femoris and Triceps Surae Muscles to Pulmonary Rehabilitation in COPD : Randomized Clinical Trial

Patients with COPD frequently have muscle disorders. Pathogenic mechanisms generate significant pathophysiological changes in the locomotor muscles structure, leading to decreased strength, decreased endurance and limited exercise capacity.

Pulmonary rehabilitation is the first choice therapy and training overall lower limb endurance is a priority. Even if the effects of pulmonary rehabilitation are no longer to be demonstrated, it is still necessary to optimize the modalities of muscular strengthening. In fact, it is recommended to associate to this global endurance training a specific strengthening of the muscles of the lower limbs. Neuromuscular electrostimulation (NMES) is a muscular strengthening technique, but this method is not used in usual practice in pulmonary rehabilitation and often only the quadriceps are concerned. In a pulmonary rehabilitation program, including sessions of NMES of the quadriceps femoris and triceps surae could increase its effectiveness.

Recent studies suggest that NMES can improve muscle function, exercise tolerance, dyspnea and quality of life in COPD patients.

A pilot study compared the effects of the combined quadriceps femoris and triceps surae versus quadriceps alone. The final evaluation showed a greater improvement in exercise capacity in favour of the combined NMES group. Only two studies with small numbers of patients evaluated the effect of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation, with encouraging results in terms of functional gain. Further larger studies seem necessary to evaluate the effects of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation. The objective of the study is to show that combined quadriceps femoris and triceps surae NMES during a pulmonary rehabilitation program provides a more significant improvement in exercise capacity compared to a standard pulmonary rehabilitation program.

Study Overview

• Status: Recruiting
• Conditions: Asthma; Chronic Obstructive Pulmonary Disease Overlap Syndrome
• Intervention / Treatment: Device: Neuromuscular Electrical Stimulation; Device: Sham Neuromuscular Electrical Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 266
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Loïc Peran; Phone Number: 02 98 62 61 60; Email: lperan@ch-morlaix.fr
• Study Contact Backup: Name: Marc BEAUMONT; Phone Number: 02 98 62 61 60; Email: mbeaumont@ch-morlaix.fr

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • CHU La Cavale Blanche
    • Contact: Francis COUTURAUD, PHD; Phone Number: 02 98 22 33 33; Email: francis.couturaud@chu-brest.fr
    • Contact: Christophe GUT-GOBERT, PHD; Phone Number: 02 98 34 73 65; Email: chritophe.gut-gobert@chu-brest.fr

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patient with COPD stages 2 to 4 (A to D) admitted to the Pulmonary Rehabilitation Department of the "Centre Hospitalier des Pays de Morlaix" or the "CHRU of Brest".
• Patient aged 18 years or older.
• Patient able to consent and having signed a consent form.

Exclusion Criteria:

• Patient with a history of pneumonectomy, lobectomy dated less than 6 months old
• Patient with an inability to complete a respiratory rehabilitation program in its entirety
• Patient under guardianship or curatorship
• Person equipped with electronic devices such as pacemakers and intracardiac defibrillators.
• Skin lesions and infectious foci on the area where the electrodes.
• Pregnant or breastfeeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group (EG); Randomized intervention in the NMES (GE) group: Patients in the NMES group will receive, in addition to conventional rehabilitation, combined quadriceps femoris and triceps surae NMES. Detail of the NMES : Stimulation is performed in a semi-seated position, biphasic current, 8 channels in total (possibility of 16 electrodes).; One device per lower limb of each patient is necessary: 4 electrodes are placed on the quadriceps and 4 electrodes on the triceps, on each lower limb.; Stimulation frequency: 50hz.; Pulse duration: 400 μs.; Contraction time: 6 seconds.; Rest time: 6 seconds.; The intensity must generate a visible muscular contraction and must be well supported. by the patient.; The voluntary contraction accompanies the electrical stimulation.; Surface electrode 50 × 50 mm.	Device: Neuromuscular Electrical Stimulation; Standart pulmonary rehabilitation with combined quadriceps and triceps surae ESNM using two identical electrotherapy devices allowing simultaneous stimulation of the quadriceps and triceps (EG group).
Sham Comparator: Control group (CG); Patients in the control group (GC) will receive, in addition to the classical rehabilitation, the combined sham NMES of the quadriceps femoris and triceps surae. Detail of the NMES : It is carried out 5 times a week for 4 weeks, supervised by a physiotherapist.; The device used will be the same as in the EG group.; Stimulation is performed in a semi-seated position, biphasic current, 8 channels in total (16 electrodes can be used).; One device per lower limb of each patient is required: 4 electrodes are placed on the quadriceps and 4 electrodes on the triceps, on each lower limb.; Stimulation frequency: 5hz.; Pulse duration: 100 μs.; Contraction time: 6 seconds.; Rest time: 6 seconds.; The intensity must generate a visible muscle contraction and must be well supported by the patient.; The voluntary contraction accompanies the electrical stimulation.; Surface electrode 50 × 50 mm.	Device: Sham Neuromuscular Electrical Stimulation; Standart pulmonary rehabilitation with combined sham NMES of the quadriceps and triceps surae performed using two identical electrotherapy devices allowing simultaneous stimulation of the quadriceps and triceps (CG group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking distance change	Assessment of the walking distance (in meters) covered during the 6-minute walking test before and after rehabilitation (between D0 and D28± 4 days). The main endpoint is the change (in meters) between Day 0 and Day 28.	Day 0 and Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal isometric voluntary quadriceps strengh	Maximal isometric voluntary quadriceps strengh assessment (in newton) with handheld dynamometer	Day 0 and Day 28
Maximal isometric voluntary endurance change	Maximal isometric voluntary endurance assessment with handheld dynamometer	Day 0 and Day 28
Maximal isometric voluntary triceps surae strengh change	Maximal isometric voluntary triceps surae strengh assessment (in newton) with dynamometer type MICROFET 2 before and after rehabilitation.	Day 0 and Day 28
Exercise capacity change with the 1 min sit to stand test	Exercise capacity assessment during the 1 min sit to stand test before and after rehabilitation.	Day 0 and Day 28
Exercise capacity change with the 6 min step test	Exercise capacity assessment during the 6 min step test before and after rehabilitation.	Day 0 and Day 28
Exercise capacity change with the incremental shuttle test	Exercise capacity assessment during the incremental shuttle test before and after rehabilitation.	Day 0 and Day 28
Exercise capacity change with the endurance shuttle walk test	Exercise capacity assessment during the endurance shuttle walk test before and after rehabilitation. before and after rehabilitation.	Day 0 and Day 28
Dyspnea change during the 6-minute walking test	Dyspnea assessment at the end of the 6-minute walking test, with the Borg scale, before and after rehabilitation	Day 0 and Day 28
Dyspnea change during the 6-minute walking test	Dyspnea assessment at the end of the 6-minute walking test, with the Multidimensional dyspnea profile questionnaire, before and after rehabilitation	Day 0 and Day 28
Isotime dyspnea change with the endurance shuttle walk test	Isotime dyspnea assessment during the endurance shuttle walk test, using Borg scale after rehabilitation.	Day 28
Dyspnea change with the mMRC (modified Medical Research Council) scale	Assessment of dyspnea with the mMRC scale (min : 0 ; max : 4), before and after rehabilitation.	Day 0 and Day 28
Dyspnea change with the LCADL (London Chest Activity of Daily Living) questionnaire	Assessment of dyspnea with the LCADL questionnaire (better score : 0; worse score: 5), before and after rehabilitation.	Day 0 and Day 28
Dyspnea change with the Dyspnea-12 questionnaire	Assessment of dyspnea with the Dyspnea-12 questionnaire, before and after rehabilitation.	Day 0 and Day 28
Quality of life change with the St George's Respiratory Questionnaire	Quality of life assessment with the St George's Respiratory Questionnaire, before and after rehabilitation.	Day 0 and Day 28
Quality of life change with the CAT (COPD Assessment Test) Questionnaire	Quality of life assessment with COPD Assessment Test (better : 0; worse : 5), before and after rehabilitation.	Day 0 and Day 28
Fear of fall change with the FES (Falls Efficacy Scale) questionnaire	Fear of fall (FES-I Questionnaire) assessment (better : 1; worse : 4), before and after rehabilitation.	Day 0 and Day 28
Anxiety disorder change	Anxiety disorder assessment (HAD questionnaire) (better : 0; worse : 3) before and after rehabilitation.	Day 0 and Day 28
Depressive disorder change	Depressive disorder assessment (HAD questionnaire) (better : 0; worse : 3) before and after rehabilitation.	Day 0 and Day 28
Non fat mass index change	Assessment of the non fat mass index with impedancemetry , before and after rehabilitation.	Day 0 and Day 28
Self esteem change	Self esteem assessment with PSI-6 (Physical Self Inventory) questionnaire (worse :0 ; better :10)	Day 0 and Day 28

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Estimated): November 6, 2025
• Study Completion (Estimated): November 6, 2025

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: COPD; Neuromuscular Electrical Stimulation; Pulmonary Rehabilitation; Muscular Strengthening
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 29BRC20.0249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No