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

NCT ID: NCT04684966

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-08
• Study Completion Date: 2024-12-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type: 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).

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.

Group Type: SHAM_COMPARATOR

Sham Neuromuscular Electrical Stimulation

Intervention Type: 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)

Interventions

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).

Intervention Type: 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)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU La Cavale Blanche

Brest, France, France

Countries

France

Other Identifiers

29BRC20.0249

Identifier Type: -

Identifier Source: org_study_id