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NCT Number: NCT06172946

Effect of Powerbreath Versus Transcutaneous Electrical Diaphragmatic Stimulation on The Severity of Copd

Chronic obstructive pulmonary disease (COPD) is a common and treatable disease characterized by progressive airflow limitation and tissue destruction. It is associated with structural lung changes due to chronic inflammation from prolonged exposure to noxious particles or gases most commonly cigarette smoke.

POWERbreathe device (POWER-breathe International Ltd., Southam, Warwickshire, UK) is an inspiratory muscle training and this device has recently shown benefits on pulmonary function. Also, the POWER-breathe® device's effects on the strength of the diaphragm muscle and minimize muscle weakness and wasting in COPD patients.

Neuromuscular electrical stimulation (NMES) is commonly used in physical therapy to increase muscle strength and promote muscle hypertrophy. NMES applied to respiratory rehabilitation is called transcutaneous electrical diaphragmatic stimulation (TEDS).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 11432, Egypt

About this study

sixty Patients will be assigned randomly into two equal groups with pre and post treatment protocol application.

Group A:

Thirty patients will be treated by power breathe along with their prescribed medication.

Group B:

Thirty patients will be treated by Transcutaneous electrical Diaphragmatic Stimulation (TEDS) along with their prescribed medication.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patient selection will be according to the following criteria:
  • Male patients diagnosed with stage 2&3 COPD.
  • All patients are under full medical control.
  • Their ages will range from forty-five to sixty-five years.
  • Patients with BMI from 25-29.9 kg/m2

Exclusion criteria

  • Patients with the following criteria will be excluded from the study:
  • Lack of language or cognitive abilities to fill out questionnaire.
  • Patients with cardiac pacemaker.
  • Contraindications for inspiratory muscle training (e.g. a history of recent lung surgery, recent pulmonary embolism, history of recurrent spontaneous pneumothorax, other serious lung disease).
  • Existing arterial aneurysm.
  • Clinical signs of unstable cardiac event (eg. congestive heart failure).
  • Patients with malignant disease.
  • Acute COPD exacerbation within the last 4 weeks.
  • Any need for supplemental oxygen.
  • Patients with Gastro-esophageal reflux disease.
  • Patients with active Hemoptysis.

Treatment and study plan

powerbreath

Device

Previous studies have confirmed the efficacy of implementing IMT as part of a RR program in a certain profile of patients with COPD, showing improvements in maximum inspiratory pressure, perception of well-being, and other respiratory diseases, and dyspnea during exercise. (Gandullo et al., 2022)

TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION

Device

Transcutaneous electrical diaphragmatic stimulation (TEDS) has been used to improve respiratory muscle strength in patients with respiratory muscle weakness. A previous study reported that patients with chronic obstructive pulmonary disease (COPD) showed increased lung volume and oxygen saturation after a single session of TEDS. (Hsin et al., 2022)

Primary outcomes

  1. The COPD Assessment Test (CAT)

    Time frame: COPD Assessment Test will be measured at baseline, and it will be measured again after eight weeks

    The COPD Assessment Test(CAT) is validated questionnaire consisting of eight items, which evaluate the most burdensome symptoms and limitations of the patients. The score for each item ranges from 0 to 5 and the total score (0-40)

Secondary outcomes

  1. Pulmonary function: By Spirometry Device:

    Time frame: Pulmonary function: By Spirometry Device: forced vital capacity will be measured at baseline, and it will be measured again after eight weeks

    • Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced vital capacity (FVC)

  2. Pulmonary function: By Spirometry Device:

    Time frame: Pulmonary function: By Spirometry Device: forced expiratory volume in one second will be measured at baseline, and it will be measured again after eight weeks

    • Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced expiratory volume in one second (FEV1)

  3. Pulmonary function: By Spirometry Device:

    Time frame: Pulmonary function: By Spirometry Device: forced expiratory volume in one second/forced expiratory volume will be measured at baseline, and it will be measured again after eight weeks

    • Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced expiratory volume in one second/forced expiratory volume (FEV1/FVC)

  4. Pulmonary function: By Spirometry Device:

    Time frame: Pulmonary function: By Spirometry Device: forced expiratory flow will be measured at baseline, and it will be measured again after eight weeks

    • Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced expiratory floe(FEF25-75%)

  5. Diaphragmatic Thickness: By Ultrasonography:

    Time frame: Diaphragmatic Thickness: By Ultrasonography:will be measured at baseline, and it will be measured again after eight weeks

    • Diaphragmatic Thickness: By Ultrasonography: provides a simple and non-invasive means of assessing diaphragmatic function. (Boussuges et al., 2020)

  6. Measuring functional capacity: By Six-minute walk test (6MWT):

    Time frame: Measuring functional capacity: By Six-minute walk test (6MWT)::will be measured at baseline, and it will be measured again after eight weeks

    • Measuring functional capacity: By Six-minute walk test (6MWT): is a self paced submaximal field exercise test , It will be performed according to the standard procedure is administered in a 30 meter hallway. (Launois et al., 2012 and ATS statement2002)

  7. Modified Medical Research Council dyspnea scale (mMRC dyspnea scale):

    Time frame: Modified Medical Research Council dyspnea scale (mMRC dyspnea scale):will be measured at baseline, and it will be measured again after eight weeks

    • Dyspnea: By Modified Medical Research Council dyspnea scale (mMRC dyspnea scale): It is a 5 point scale based on degrees of variable physical activities that precipitate dyspnea with a score ranging from 0 to 4. (Richards, 2017)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Inspiratory Muscle Training Versus Transcutaneous Electrical Diaphragmatic Stimulation on The Severity of Copd

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 15, 2023
Registry last updated
Feb 18, 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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