Clinical trial NCT06172946: Effect of Powerbreath Versus Transcutaneous Electrical Diaphragmatic Stimulation on The Severity of Copd
Official title: Effect of Inspiratory Muscle Training Versus Transcutaneous Electrical Diaphragmatic Stimulation on The Severity of Copd
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 60
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The COPD Assessment Test (CAT)
timeFrame: COPD Assessment Test will be measured at baseline, and it will be measured again after eight weeks
Secondary outcomes:
measure: Pulmonary function: By Spirometry Device:
timeFrame: Pulmonary function: By Spirometry Device: forced vital capacity will be measured at baseline, and it will be measured again after eight weeks
measure: Pulmonary function: By Spirometry Device:
timeFrame: 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
measure: Pulmonary function: By Spirometry Device:
timeFrame: 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
measure: Pulmonary function: By Spirometry Device:
timeFrame: Pulmonary function: By Spirometry Device: forced expiratory flow will be measured at baseline, and it will be measured again after eight weeks
measure: Diaphragmatic Thickness: By Ultrasonography:
timeFrame: Diaphragmatic Thickness: By Ultrasonography:will be measured at baseline, and it will be measured again after eight weeks
measure: Measuring functional capacity: By Six-minute walk test (6MWT):
timeFrame: Measuring functional capacity: By Six-minute walk test (6MWT)::will be measured at baseline, and it will be measured again after eight weeks
measure: Modified Medical Research Council dyspnea scale (mMRC dyspnea scale):
timeFrame: Modified Medical Research Council dyspnea scale (mMRC dyspnea scale):will be measured at baseline, and it will be measured again after eight weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: