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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04684966
Other study ID # 29BRC20.0249
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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