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

NCT ID: NCT06172946

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-12
• Study Completion Date: 2025-01-01

Brief 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).

Detailed 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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

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

Study Groups

INSPIRATORY MUSCLE TRAINING

Power Breathe:

(3times/week for 8 weeks) The patient should inhale and exhale through the mouthpiece 30 times maximum. The training load is adjustable and should be set at a level appropriate for the patient to effectively train the inspiratory muscles. (Lázaro et al., 2021)

Group Type: EXPERIMENTAL

powerbreath

Intervention Type: 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

Transcutaneous electrical Diaphragmatic Stimulation(TEDS):

(3times/week for 8 weeks) During each session, rectangular electrodes were placed on the parasternal region beside the xiphoid process; the sixth and seventh intercostal spaces in line with the mid-axillary line. The electrical current is pulsed, biphasic and symmetric, with the following parameters: frequency of 30 Hertz; 0.4ms phase width, rise time of 0.7 seconds; respiratory rate of 14 rpm; intensity is the minimum necessary to obtain diaphragm muscle contraction. TEDS intensity was gradually increased until visible muscle contraction was observed. (Hsin et al., 2022)

Group Type: ACTIVE_COMPARATOR

TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION

Intervention Type: 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)

Interventions

powerbreath

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)

Intervention Type: DEVICE

TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION

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)

Intervention Type: DEVICE

Eligibility Criteria

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 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 recent lung surgery, recent pulmonary embolism, history of recurrent spontaneous pneumothorax, 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mohamed El-Moatasem Mohamed

lecturer of physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004626

Identifier Type: -

Identifier Source: org_study_id