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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05382780
Enrollment
80
Registered
2022-05-19
Start date
2022-06-01
Completion date
2022-11-15
Last updated
2022-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, COVID-19

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.

Interventions

OTHERThe 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.

OTHERDiaphragmatic 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

OTHERinterval aerobic training and respiratory training

mild intensity interval aerobic training and respiratory training on treadmill

Sponsors

Horus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of change in Forced expiratory volume in the first one second expressed as percentage of the predicted FEV1at baseline and 3 months of interventionTo 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 Physical Fitness Index (PFI)at baseline and 3 months of interventionTo 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 Rate Pressure Productat baseline and 3 months of interventionTo 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 Forced vital capacityat baseline and 3 months of interventionTo 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 secondat baseline and 3 months of interventionTo 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 Ratio of forced expiratory volume in the first one second to the forced vital capacity of lungsat baseline and 3 months of interventionTo 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 Maximum voluntry ventilationat baseline and 3 months of interventionTo assess the change in the maximum voluntary ventilation (MVV) by spirometry. The unit of measure is the liters/ minute.
Assessment of change in Forced vital capacity expressed as percentage of the predicted FVCat baseline and 3 months of interventionTo 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

MeasureTime frameDescription
Assessment of change in Oxygen saturationat baseline and 3 months of interventionTo assess the change in the Oxygen saturation using pulse oximeter device.

Countries

Egypt

Contacts

Primary ContactEman Rashad, Assistant lecturer
eali@horus.edu.eg+201011431165

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026