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

NCT04684966 | Completed

• 1 other identifier: 29BRC20.0249
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease Overlap Syndrome; Asthma

Keywords

Pulmonary Rehabilitation; Neuromuscular Electrical Stimulation; COPD; Muscular Strengthening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Maximal isometric voluntary quadriceps strengh

  Day 0 and Day 28

• Maximal isometric voluntary endurance change

  Day 0 and Day 28

• Maximal isometric voluntary triceps surae strengh change

  Day 0 and Day 28

• Exercise capacity change with the 1 min sit to stand test

  Day 0 and Day 28

• Exercise capacity change with the 6 min step test

  Day 0 and Day 28

Study Arms (2)

Experimental group (EG)

EXPERIMENTAL

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

Control group (CG)

SHAM COMPARATOR

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

Interventions

Neuromuscular Electrical Stimulation DEVICE

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).

Experimental group (EG)

Sham Neuromuscular Electrical Stimulation DEVICE

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)

Control group (CG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU La Cavale Blanche

Brest, France, 29200, France

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 28, 2020
• Study Start: April 8, 2021
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

FR (1)