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

Asthma Clinical Trial

— COMBIELEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04684966
• Other study ID #: 29BRC20.0249
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2021
• Est. completion date: November 6, 2025

Study information

• Verified date: January 2024
• Source: University Hospital, Brest
• Contact: Loïc Peran
• Phone: 02 98 62 61 60
• Email: lperan[@]ch-morlaix.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: November 6, 2025
• Est. primary completion date: November 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease Overlap Syndrome
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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 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)

Locations

Country	Name	City	State
France	CHU La Cavale Blanche	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximal isometric voluntary quadriceps strengh	Maximal isometric voluntary quadriceps strengh assessment (in newton) with handheld dynamometer	Day 0 and Day 28
Secondary	Maximal isometric voluntary endurance change	Maximal isometric voluntary endurance assessment with handheld dynamometer	Day 0 and Day 28
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Dyspnea change with the Dyspnea-12 questionnaire	Assessment of dyspnea with the Dyspnea-12 questionnaire, before and after rehabilitation.	Day 0 and Day 28
Secondary	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
Secondary	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
Secondary	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
Secondary	Anxiety disorder change	Anxiety disorder assessment (HAD questionnaire) (better : 0; worse : 3) before and after rehabilitation.	Day 0 and Day 28
Secondary	Depressive disorder change	Depressive disorder assessment (HAD questionnaire) (better : 0; worse : 3) before and after rehabilitation.	Day 0 and Day 28
Secondary	Non fat mass index change	Assessment of the non fat mass index with impedancemetry , before and after rehabilitation.	Day 0 and Day 28
Secondary	Self esteem change	Self esteem assessment with PSI-6 (Physical Self Inventory) questionnaire (worse :0 ; better :10)	Day 0 and Day 28