Clinical trial NCT04684966: Combined Neuromuscular Electrical Stimulation for Quadriceps and Triceps During Pulmonary Rehabilitation in COPD
Official title: Interest of Adding Neuromuscular Electrical Stimulation for Quadriceps Femoris and Triceps Surae Muscles to Pulmonary Rehabilitation in COPD : Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease Overlap Syndrome
Asthma
Keywords: Pulmonary Rehabilitation
Neuromuscular Electrical Stimulation
COPD
Muscular Strengthening
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Walking distance change
timeFrame: Day 0 and Day 28
Secondary outcomes:
measure: Maximal isometric voluntary quadriceps strengh
timeFrame: Day 0 and Day 28
measure: Maximal isometric voluntary endurance change
timeFrame: Day 0 and Day 28
measure: Maximal isometric voluntary triceps surae strengh change
timeFrame: Day 0 and Day 28
measure: Exercise capacity change with the 1 min sit to stand test
timeFrame: Day 0 and Day 28
measure: Exercise capacity change with the 6 min step test
timeFrame: Day 0 and Day 28
measure: Exercise capacity change with the incremental shuttle test
timeFrame: Day 0 and Day 28
measure: Exercise capacity change with the endurance shuttle walk test
timeFrame: Day 0 and Day 28
measure: Dyspnea change during the 6-minute walking test
timeFrame: Day 0 and Day 28
measure: Dyspnea change during the 6-minute walking test
timeFrame: Day 0 and Day 28
measure: Isotime dyspnea change with the endurance shuttle walk test
timeFrame: Day 28
measure: Dyspnea change with the mMRC (modified Medical Research Council) scale
timeFrame: Day 0 and Day 28
measure: Dyspnea change with the LCADL (London Chest Activity of Daily Living) questionnaire
timeFrame: Day 0 and Day 28
measure: Dyspnea change with the Dyspnea-12 questionnaire
timeFrame: Day 0 and Day 28
measure: Quality of life change with the St George's Respiratory Questionnaire
timeFrame: Day 0 and Day 28
measure: Quality of life change with the CAT (COPD Assessment Test) Questionnaire
timeFrame: Day 0 and Day 28
measure: Fear of fall change with the FES (Falls Efficacy Scale) questionnaire
timeFrame: Day 0 and Day 28
measure: Anxiety disorder change
timeFrame: Day 0 and Day 28
measure: Depressive disorder change
timeFrame: Day 0 and Day 28
measure: Non fat mass index change
timeFrame: Day 0 and Day 28
measure: Self esteem change
timeFrame: Day 0 and Day 28
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU La Cavale Blanche
Study officials:
References: