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Clinical Trials/NCT06172946
NCT06172946
Completed
Not Applicable

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

Cairo University1 site in 1 country60 target enrollmentDecember 12, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Cairo University
Enrollment
60
Locations
1
Primary Endpoint
The COPD Assessment Test (CAT)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 12, 2023
End Date
January 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alaa Mohamed El-Moatasem Mohamed

lecturer of physical therapy

Cairo University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

The COPD Assessment Test (CAT)

Time Frame: 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 Outcomes

  • 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)
  • 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)
  • 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)

Study Sites (1)

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