Breather Trainer Versus Pulmonary Rehabilitation on Cardiopulmonary Efficiency

NCT ID: NCT05382780

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-11-15

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.

Conditions

COVID-19; COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

The breather respiratory muscle trainer

Intervention Type: OTHER

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.

interval aerobic training and respiratory training

Intervention Type: OTHER

mild intensity interval aerobic training and respiratory training on treadmill

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,

Group Type: EXPERIMENTAL

Diaphragmatic and localized breathing exercises

Intervention Type: OTHER

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

Intervention Type: OTHER

mild intensity interval aerobic training and respiratory training on treadmill

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

interval aerobic training and respiratory training

mild intensity interval aerobic training and respiratory training on treadmill

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Horus University

OTHER

Sponsor Role: lead

Responsible Party

Eman Rashad Ali Elsayed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman Rashad, Assistant lecturer

Role: PRINCIPAL_INVESTIGATOR

Horus University in Egypt

Locations

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

Damietta, , Egypt

Countries

Egypt

Central Contacts

Eman Rashad, Assistant lecturer

Role: CONTACT

eali@horus.edu.eg

+201011431165

Other Identifiers

Eman_Rashad_PhD_2022

Identifier Type: -

Identifier Source: org_study_id