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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effect of Inspiratory Muscle Training Versus Transcutaneous Electrical Diaphragmatic Stimulation on The Severity of Copd

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172946
• Other study ID #: P.T.REC/012/004626
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2023
• Est. completion date: April 2024

Study information

• Verified date: December 2023
• Source: Cairo University
• Contact: Alaa El-moatasem, lecturer
• Phone: 01006625054
• Email: alaamotasem[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• 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)
• 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)

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pulmonary function: By Spirometry Device:	• Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced vital capacity (FVC)	Pulmonary function: By Spirometry Device: forced vital capacity will be measured at baseline, and it will be measured again after eight weeks
Secondary	Pulmonary function: By Spirometry Device:	• Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced expiratory volume in one second (FEV1)	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
Secondary	Pulmonary function: By Spirometry Device:	• Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced expiratory volume in one second/forced expiratory volume (FEV1/FVC)	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
Secondary	Pulmonary function: By Spirometry Device:	• Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced expiratory floe(FEF25-75%)	Pulmonary function: By Spirometry Device: forced expiratory flow will be measured at baseline, and it will be measured again after eight weeks
Secondary	Diaphragmatic Thickness: By Ultrasonography:	• Diaphragmatic Thickness: By Ultrasonography: provides a simple and non-invasive means of assessing diaphragmatic function. (Boussuges et al., 2020)	Diaphragmatic Thickness: By Ultrasonography:will be measured at baseline, and it will be measured again after eight weeks
Secondary	Measuring functional capacity: By Six-minute walk test (6MWT):	• 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)	Measuring functional capacity: By Six-minute walk test (6MWT)::will be measured at baseline, and it will be measured again after eight weeks
Secondary	Modified Medical Research Council dyspnea scale (mMRC dyspnea scale):	• 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)	Modified Medical Research Council dyspnea scale (mMRC dyspnea scale):will be measured at baseline, and it will be measured again after eight weeks