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Breather Trainer Versus Pulmonary Rehabilitation on Cardiopulmonary Efficiency

Primary Purpose

COVID-19, COPD

Status

Not yet recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

The breather respiratory muscle trainer

Diaphragmatic and localized breathing exercises

interval aerobic training and respiratory training

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

30 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

SPO2 ≥ 93%
Their age ranges from 30-40 years old.
COPD patients GOLD1 (Mild FEV1≥80% predicted) and GOLD2 (Moderate 50% ≤FEV1<80%predicted) (Manian, 2019)
patients diagnosed as post COVID-19 Pneumonia between 3 and 6 Months ago with CT scan and PCR testing.
Their body mass index (BMI) ranged from 20 to 29.9kg/m2.
Stable medical cases with dyspnea

Exclusion Criteria:

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

patients with cardiac problems e.g. atrial fibrillation, left bundle-branch block, heart failure.
Sever cases of COPD (FEV1/FVC< 50%)
Mitral or aortic valvular disease, pericardial effusion.
Recent myocardial infarction.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

The breather respiratory muscle trainer group

Diaphragmatic and localized breathing exercises group

Arm Description

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.

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,

Outcomes

Primary Outcome Measures

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

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

Assessment of change in Forced vital capacity

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

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 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.

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.

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.

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.

Secondary Outcome Measures

Assessment of change in Oxygen saturation

To assess the change in the Oxygen saturation using pulse oximeter device.

Full Information

NCT ID

NCT05382780

First Posted

April 24, 2022

Last Updated

May 17, 2022

Sponsor

Horus University

1. Study Identification

Unique Protocol Identification Number

NCT05382780

Brief Title

Breather Trainer Versus Pulmonary Rehabilitation on Cardiopulmonary Efficiency

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 1, 2022 (Anticipated)

Primary Completion Date

October 15, 2022 (Anticipated)

Study Completion Date

November 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Horus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

The breather respiratory muscle trainer group

Arm Type

Experimental

Arm Description

Arm Title

Diaphragmatic and localized breathing exercises group

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

The breather respiratory muscle trainer

Intervention Description

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

Intervention Name(s)

Diaphragmatic and localized breathing exercises

Intervention Description

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

Intervention Name(s)

interval aerobic training and respiratory training

Intervention Description

mild intensity interval aerobic training and respiratory training on treadmill

Primary Outcome Measure Information:

Title

Assessment of change in Physical Fitness Index (PFI)

Description

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

Time Frame

at baseline and 3 months of intervention

Title

Assessment of change in Rate Pressure Product

Description

Time Frame

at baseline and 3 months of intervention

Title

Assessment of change in Forced vital capacity

Description

To assess the change in Forced vital capacity (FVC) by spirometry. The unit of measure is liters.

Time Frame

at baseline and 3 months of intervention

Title

Assessment of change in Forced expiratory volume in the first one second

Description

To assess the change in Forced expiratory volume in the first one second (FEV1) by spirometry. The unit of measure is liters.

Time Frame

at baseline and 3 months of intervention

Title

Assessment of change in Ratio of forced expiratory volume in the first one second to the forced vital capacity of lungs

Description

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.

Time Frame

at baseline and 3 months of intervention

Title

Assessment of change in Maximum voluntry ventilation

Description

To assess the change in the maximum voluntary ventilation (MVV) by spirometry. The unit of measure is the liters/ minute.

Time Frame

at baseline and 3 months of intervention

Title

Assessment of change in Forced vital capacity expressed as percentage of the predicted FVC

Description

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.

Time Frame

at baseline and 3 months of intervention

Title

Assessment of change in Forced expiratory volume in the first one second expressed as percentage of the predicted FEV1

Description

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.

Time Frame

at baseline and 3 months of intervention

Secondary Outcome Measure Information:

Title

Assessment of change in Oxygen saturation

Description

To assess the change in the Oxygen saturation using pulse oximeter device.

Time Frame

at baseline and 3 months of intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: SPO2 ≥ 93% Their age ranges from 30-40 years old. COPD patients GOLD1 (Mild FEV1≥80% predicted) and GOLD2 (Moderate 50% ≤FEV1<80%predicted) (Manian, 2019) patients diagnosed as post COVID-19 Pneumonia between 3 and 6 Months ago with CT scan and PCR testing. Their body mass index (BMI) ranged from 20 to 29.9kg/m2. Stable medical cases with dyspnea Exclusion Criteria: Patients who will meet one of the following criteria will be excluded from the study: patients with cardiac problems e.g. atrial fibrillation, left bundle-branch block, heart failure. Sever cases of COPD (FEV1/FVC< 50%) Mitral or aortic valvular disease, pericardial effusion. Recent myocardial infarction.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eman Rashad, Assistant lecturer

Phone

+201011431165

eali@horus.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eman Rashad, Assistant lecturer

Organizational Affiliation

Horus University in Egypt

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Damietta

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Breather Trainer Versus Pulmonary Rehabilitation on Cardiopulmonary Efficiency

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