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

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: powerbreath; Device: TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION

• Registration Number: NCT06172946
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-03
• Study Start: 2023-12-12
• Study First Submitted QC: 2023-12-13
• Last Update Submitted: 2023-12-13
• Study First Posted: 2023-12-15
• Last Update Posted: 2023-12-15
• Primary Completion: 2024-03
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

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

  1. Male patients diagnosed with stage 3&4 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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INSPIRATORY MUSCLE TRAINING	powerbreath	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)
TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION	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)

Primary Outcome Measures

Name	Time	Method
The COPD Assessment Test (CAT)	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 Outcome Measures

Name	Time	Method
Measuring functional capacity: By Six-minute walk test (6MWT):	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)
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	• Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced expiratory floe(FEF25-75%)
Diaphragmatic Thickness: By Ultrasonography:	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)
Modified Medical Research Council dyspnea scale (mMRC dyspnea scale):	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)

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt