Breather Trainer Versus Pulmonary Rehabilitation on Cardiopulmonary Efficiency

Not Applicable

• Conditions: COPD; COVID-19
• Interventions: Other: Diaphragmatic and localized breathing exercises; Other: The breather respiratory muscle trainer; Other: interval aerobic training and respiratory training

• Registration Number: NCT05382780
• Lead Sponsor: Horus University

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.

Study Timeline

• Study First Submitted: 2022-04-24
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-17
• Last Update Submitted: 2022-05-17
• Study First Posted: 2022-05-19
• Last Update Posted: 2022-05-19
• Study Start: 2022-06-01
• Primary Completion: 2022-10-15
• Study Completion: 2022-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diaphragmatic and localized breathing exercises group	Diaphragmatic and localized breathing exercises	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,
Diaphragmatic and localized breathing exercises group	interval aerobic training and respiratory training	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,
The breather respiratory muscle trainer group	interval aerobic training and respiratory training	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.
The breather respiratory muscle trainer group	The breather respiratory muscle trainer	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.

Primary Outcome Measures

Name	Time	Method
Assessment of change in Physical Fitness Index (PFI)	at baseline and 3 months of intervention	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
Assessment of change in Forced vital capacity	at baseline and 3 months of intervention	To assess the change in Forced vital capacity (FVC) by spirometry. The unit of measure is liters.
Assessment of change in Forced expiratory volume in the first one second	at baseline and 3 months of intervention	To assess the change in Forced expiratory volume in the first one second (FEV1) by spirometry. The unit of measure is liters.
Assessment of change in Forced expiratory volume in the first one second expressed as percentage of the predicted FEV1	at baseline and 3 months of intervention	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.
Assessment of change in Rate Pressure Product	at baseline and 3 months of intervention	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
Assessment of change in Maximum voluntry ventilation	at baseline and 3 months of intervention	To assess the change in the maximum voluntary ventilation (MVV) by spirometry. The unit of measure is the liters/ minute.
Assessment of change in Ratio of forced expiratory volume in the first one second to the forced vital capacity of lungs	at baseline and 3 months of intervention	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.
Assessment of change in Forced vital capacity expressed as percentage of the predicted FVC	at baseline and 3 months of intervention	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of change in Oxygen saturation	at baseline and 3 months of intervention	To assess the change in the Oxygen saturation using pulse oximeter device.

Trial Locations

Locations (1)

Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt; 🇪🇬 Damietta, Egypt