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

Last updated: February 15, 2025
Sponsor: Cairo University
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

powerbreath

TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION

Clinical Study ID

NCT06172946
P.T.REC/012/004626
  • Ages 45-65
  • Male

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient selection will be according to the following criteria:

  1. Male patients diagnosed with stage 2&3 COPD.

  2. All patients are under full medical control.

  3. Their ages will range from forty-five to sixty-five years.

  4. Patients with BMI from 25-29.9 kg/m2

Exclusion

Exclusion Criteria:

  • Patients with the following criteria will be excluded from the study:

  1. Lack of language or cognitive abilities to fill out questionnaire.

  2. Patients with cardiac pacemaker.

  3. Contraindications for inspiratory muscle training (e.g. a history of recentlung surgery, recent pulmonary embolism, history of recurrent spontaneouspneumothorax, other serious lung disease).

  4. Existing arterial aneurysm.

  5. Clinical signs of unstable cardiac event (eg. congestive heart failure).

  6. Patients with malignant disease.

  7. Acute COPD exacerbation within the last 4 weeks.

  8. Any need for supplemental oxygen.

  9. Patients with Gastro-esophageal reflux disease.

  10. Patients with active Hemoptysis.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: powerbreath
Phase:
Study Start date:
December 12, 2023
Estimated Completion Date:
January 01, 2025

Study Description

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.

Connect with a study center

  • Cairo University

    Cairo, 11432
    Egypt

    Site Not Available

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