Breather Trainer Versus Pulmonary Rehabilitation on Cardiopulmonary Efficiency

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05382780
• Other study ID #: Eman_Rashad_PhD_2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: May 2022
• Source: Horus University
• Contact: Eman Rashad, Assistant lecturer
• Phone: +201011431165
• Email: eali[@]horus.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: November 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 40 Years

Eligibility

Inclusion Criteria:

1. SPO2 = 93%

2. Their age ranges from 30-40 years old.

3. COPD patients GOLD1 (Mild FEV1=80% predicted) and GOLD2 (Moderate 50% =FEV1<80%predicted) (Manian, 2019)

4. patients diagnosed as post COVID-19 Pneumonia between 3 and 6 Months ago with CT scan and PCR testing.

5. Their body mass index (BMI) ranged from 20 to 29.9kg/m2.

6. Stable medical cases with dyspnea Exclusion Criteria:

Patients who will meet one of the following criteria will be excluded from the study:

1. patients with cardiac problems e.g. atrial fibrillation, left bundle-branch block, heart failure.

2. Sever cases of COPD (FEV1/FVC< 50%)

3. Mitral or aortic valvular disease, pericardial effusion.

4. Recent myocardial infarction.

Related Conditions & MeSH terms

• COPD
• COVID-19

Intervention

Other:
• The breather respiratory muscle trainer
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.
• Diaphragmatic and localized breathing exercises
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
• interval aerobic training and respiratory training
mild intensity interval aerobic training and respiratory training on treadmill

Locations

Country	Name	City	State
Egypt	Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt	Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Horus University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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