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

Cairo University (CU)

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: powerbreath; Device: TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION

Study type: Interventional

Funder types: Other

Identifiers

NCT06172946

P.T.REC/012/004626

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

INSPIRATORY MUSCLE TRAINING

Experimental group

Description:

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)

Treatment:

Device: powerbreath

TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION

Active Comparator group

Description:

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)

Treatment:

Device: TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION