Chronic Obstructive Pulmonary Disease
Conditions
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.
Interventions
DEVICEpowerbreath
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 (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)
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
45 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function: By Spirometry Device: | Pulmonary function: By Spirometry Device: forced vital capacity will be measured at baseline, and it will be measured again after eight weeks | • Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced vital capacity (FVC) |
| 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) |
| 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) |
| 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) |
Countries
Egypt
Outcome results
None listed