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NCT Number: NCT04684966

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU La Cavale Blanche

Brest, France, 29200

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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)

Primary outcomes

  1. Walking distance change

    Time frame: Day 0 and Day 28

    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.

Secondary outcomes

  1. Maximal isometric voluntary quadriceps strengh

    Time frame: Day 0 and Day 28

    Maximal isometric voluntary quadriceps strengh assessment (in newton) with handheld dynamometer

  2. Maximal isometric voluntary endurance change

    Time frame: Day 0 and Day 28

    Maximal isometric voluntary endurance assessment with handheld dynamometer

  3. Maximal isometric voluntary triceps surae strengh change

    Time frame: Day 0 and Day 28

    Maximal isometric voluntary triceps surae strengh assessment (in newton) with dynamometer type MICROFET 2 before and after rehabilitation.

  4. Exercise capacity change with the 1 min sit to stand test

    Time frame: Day 0 and Day 28

    Exercise capacity assessment during the 1 min sit to stand test before and after rehabilitation.

  5. Exercise capacity change with the 6 min step test

    Time frame: Day 0 and Day 28

    Exercise capacity assessment during the 6 min step test before and after rehabilitation.

  6. Exercise capacity change with the incremental shuttle test

    Time frame: Day 0 and Day 28

    Exercise capacity assessment during the incremental shuttle test before and after rehabilitation.

  7. Exercise capacity change with the endurance shuttle walk test

    Time frame: Day 0 and Day 28

    Exercise capacity assessment during the endurance shuttle walk test before and after rehabilitation.

    before and after rehabilitation.

  8. Dyspnea change during the 6-minute walking test

    Time frame: Day 0 and Day 28

    Dyspnea assessment at the end of the 6-minute walking test, with the Borg scale, before and after rehabilitation

  9. Dyspnea change during the 6-minute walking test

    Time frame: Day 0 and Day 28

    Dyspnea assessment at the end of the 6-minute walking test, with the Multidimensional dyspnea profile questionnaire, before and after rehabilitation

  10. Isotime dyspnea change with the endurance shuttle walk test

    Time frame: Day 28

    Isotime dyspnea assessment during the endurance shuttle walk test, using Borg scale after rehabilitation.

  11. Dyspnea change with the mMRC (modified Medical Research Council) scale

    Time frame: Day 0 and Day 28

    Assessment of dyspnea with the mMRC scale (min : 0 ; max : 4), before and after rehabilitation.

  12. Dyspnea change with the LCADL (London Chest Activity of Daily Living) questionnaire

    Time frame: Day 0 and Day 28

    Assessment of dyspnea with the LCADL questionnaire (better score : 0; worse score: 5), before and after rehabilitation.

  13. Dyspnea change with the Dyspnea-12 questionnaire

    Time frame: Day 0 and Day 28

    Assessment of dyspnea with the Dyspnea-12 questionnaire, before and after rehabilitation.

  14. Quality of life change with the St George's Respiratory Questionnaire

    Time frame: Day 0 and Day 28

    Quality of life assessment with the St George's Respiratory Questionnaire, before and after rehabilitation.

  15. Quality of life change with the CAT (COPD Assessment Test) Questionnaire

    Time frame: Day 0 and Day 28

    Quality of life assessment with COPD Assessment Test (better : 0; worse : 5), before and after rehabilitation.

  16. Fear of fall change with the FES (Falls Efficacy Scale) questionnaire

    Time frame: Day 0 and Day 28

    Fear of fall (FES-I Questionnaire) assessment (better : 1; worse : 4), before and after rehabilitation.

  17. Anxiety disorder change

    Time frame: Day 0 and Day 28

    Anxiety disorder assessment (HAD questionnaire) (better : 0; worse : 3) before and after rehabilitation.

  18. Depressive disorder change

    Time frame: Day 0 and Day 28

    Depressive disorder assessment (HAD questionnaire) (better : 0; worse : 3) before and after rehabilitation.

  19. Non fat mass index change

    Time frame: Day 0 and Day 28

    Assessment of the non fat mass index with impedancemetry , before and after rehabilitation.

  20. Self esteem change

    Time frame: Day 0 and Day 28

    Self esteem assessment with PSI-6 (Physical Self Inventory) questionnaire (worse :0 ; better :10)

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: COMBIELEC

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 28, 2020
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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