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

NCT06172946 | Completed FDA Device

• 1 other identifier: P.T.REC/012/004626
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• The COPD Assessment Test (CAT)

  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)

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

Secondary Outcomes (7)

• Pulmonary function: By Spirometry Device:

  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:

  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:

  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:

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

• Diaphragmatic Thickness: By Ultrasonography:

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

Study Arms (2)

INSPIRATORY MUSCLE TRAINING

EXPERIMENTAL

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)

Device: powerbreath

TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION

ACTIVE COMPARATOR

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)

Device: TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION

Interventions

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)

INSPIRATORY MUSCLE TRAINING

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)

TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11432, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of physical therapy

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 15, 2023
• Study Start: December 12, 2023
• Primary Completion: March 25, 2024
• Study Completion: January 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

EG (1)