Breather Trainer Versus Pulmonary Rehabilitation on Cardiopulmonary Efficiency

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the difference between The Breather respiratory muscle trainer and pulmonary rehabilitation in patients with COPD post COVID-19.

Detailed Description
-----------------
The main concern in post COVID-19 patients is the involvement of respiratory system and cardiovascular system which may result in dyspnea, low blood oxygen saturation, and decrease cardiopulmonary efficiency. In cases of post COVID-19 patients with COPD their state is deconditioned and more critical than normal to be either in the zone of progression or regression or stability as the studies showed that handling of these cases during (3-6 months post-COVID) will prevent these symptoms from becoming permanent.

Official Title
-----------------
Effect of Breather Trainer Versus Pulmonary Rehabilitation on Cardiopulmonary Efficiency in Patients With COPD Post COVID-19

Conditions
-----------------
COVID-19, COPD

Intervention / Treatment
-----------------
* Other: The breather respiratory muscle trainer
* Other: Diaphragmatic and localized breathing exercises
* Other: interval aerobic training and respiratory training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SPO2 ≥ 93% Their age ranges from 30-40 years old. COPD patients GOLD1 (Mild FEV1≥80% predicted) and GOLD2 (Moderate 50% ≤FEV1<80%predicted) (Manian, 2019) patients diagnosed as post COVID-19 Pneumonia between 3 and 6 Months ago with CT scan and PCR testing. Their body mass index (BMI) ranged from 20 to 29.9kg/m2. Stable medical cases with dyspnea Exclusion Criteria: Patients who will meet one of the following criteria will be excluded from the study: patients with cardiac problems e.g. atrial fibrillation, left bundle-branch block, heart failure. Sever cases of COPD (FEV1/FVC< 50%) Mitral or aortic valvular disease, pericardial effusion. Recent myocardial infarction.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The breather respiratory muscle trainer group<br>40 patients (20 males and 20 females) will receive The breather respiratory muscle trainer for 30 minutes and mild interval aerobic training and respiratory training on treadmill 3 times / week for 12 weeks. | Other: The breather respiratory muscle trainer<br>* The breather respiratory muscle training device is a high quality and effective trainer designed to specifically train the inspiratory and expiratory muscles in one same breathing action. The device allows for adjustable levels of resistance using easy-to-read dials, which allows you to adjust the device to the settings you require. The inhale settings allow for adjustment 1-6 with 1 being the easiest and 6 being the hardest, while the exhale settings allow for adjustment 1-5, where 1 in the easiest and 5 the hardest.<br>Other: interval aerobic training and respiratory training<br>* mild intensity interval aerobic training and respiratory training on treadmill<br>|
| Experimental: Diaphragmatic and localized breathing exercises group<br>40 patients (20 males and 20 females) will receive diaphragmatic and localized breathing exercises ( especially Middle & Lower segments) and mild intensity interval aerobic training and respiratory training on treadmill 3 times / week for 12 weeks, | Other: Diaphragmatic and localized breathing exercises<br>* A. Diaphragmatic breathing exercises: Exercise will be performed as prescribed in the clinical guidelines for 5-10 minutes about 3-4 times per day. B. Localized Breathing: Exercise will be performed as prescribed in the clinical guidelines for 5-10 minutes about 3-4 times per day. C. Mild Interval training exercise<br>Other: interval aerobic training and respiratory training<br>* mild intensity interval aerobic training and respiratory training on treadmill<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of change in Physical Fitness Index (PFI) | To assess the change in Physical Fitness Index (PFI) By using Modified Harvard Step Test (HST): The test will be done on a step height of 33 cm height. PFI was calculated by using following formula | at baseline and 3 months of intervention | 
| Assessment of change in Rate Pressure Product | To assess the change in Rate Pressure Product. First, the baseline heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be recorded, by an aneroid sphygmomanometer. HR will be constantly displayed on pulse oximetry. The rate-pressure product (RPP) = HR X SBP | at baseline and 3 months of intervention | 
| Assessment of change in Forced vital capacity | To assess the change in Forced vital capacity (FVC) by spirometry. The unit of measure is liters. | at baseline and 3 months of intervention | 
| Assessment of change in Forced expiratory volume in the first one second | To assess the change in Forced expiratory volume in the first one second (FEV1) by spirometry. The unit of measure is liters. | at baseline and 3 months of intervention | 
| Assessment of change in Ratio of forced expiratory volume in the first one second to the forced vital capacity of lungs | To assess the change in the ratio of forced expiratory volume in the first one second to the forced vital capacity of lungs (FEV1/FVC) by spirometry. The unit of measure is the ratio. | at baseline and 3 months of intervention | 
| Assessment of change in Maximum voluntry ventilation | To assess the change in the maximum voluntary ventilation (MVV) by spirometry. The unit of measure is the liters/ minute. | at baseline and 3 months of intervention | 
| Assessment of change in Forced vital capacity expressed as percentage of the predicted FVC | To assess the change in the Forced vital capacity expressed as a percentage of the predicted FVC (FVC%) by spirometry. The unit of measure is the liters. | at baseline and 3 months of intervention | 
| Assessment of change in Forced expiratory volume in the first one second expressed as percentage of the predicted FEV1 | To assess the change in the Forced expiratory volume in the first one second expressed as a percentage of the predicted FEV1 (FEV1%) by spirometry. The unit of measure is the liters. | at baseline and 3 months of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of change in Oxygen saturation | To assess the change in the Oxygen saturation using pulse oximeter device. | at baseline and 3 months of intervention |