Breather Trainer Versus Pulmonary Rehabilitation on Cardiopulmonary Efficiency

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19; COPD
• Intervention / Treatment: Other: The breather respiratory muscle trainer; Other: interval aerobic training and respiratory training; Other: Diaphragmatic and localized breathing exercises

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eman Rashad, Assistant lecturer; Phone Number: +201011431165; Email: eali@horus.edu.eg

Study Locations

• Egypt
  • Damietta, Egypt
    • Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The breather respiratory muscle trainer group; 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; 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.; Other: interval aerobic training and respiratory training; mild intensity interval aerobic training and respiratory training on treadmill
Experimental: Diaphragmatic and localized breathing exercises group; 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: interval aerobic training and respiratory training; mild intensity interval aerobic training and respiratory training on treadmill; Other: 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

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

Collaborators and Investigators

• Sponsor: Horus University
• Investigators: Principal Investigator: Eman Rashad, Assistant lecturer, Horus University in Egypt

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): October 15, 2022
• Study Completion (Anticipated): November 15, 2022

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Eman_Rashad_PhD_2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No