Breather Trainer Versus Pulmonary Rehabilitation on Cardiopulmonary Efficiency

NCT05382780 | Unknown DMC

• 1 other identifier: Eman_Rashad_PhD_2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; COPD

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Assessment of change in Oxygen saturation

  at baseline and 3 months of intervention

Study Arms (2)

The breather respiratory muscle trainer group

EXPERIMENTAL

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; Other: interval aerobic training and respiratory training

Diaphragmatic and localized breathing exercises group

EXPERIMENTAL

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: Diaphragmatic and localized breathing exercises; Other: interval aerobic training and respiratory training

Interventions

The breather respiratory muscle trainer 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.

The breather respiratory muscle trainer group

Diaphragmatic and localized breathing exercises 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

Diaphragmatic and localized breathing exercises group

interval aerobic training and respiratory training OTHER

mild intensity interval aerobic training and respiratory training on treadmill

Diaphragmatic and localized breathing exercises group; The breather respiratory muscle trainer group

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

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

Damietta, Egypt

Location

MeSH Terms

Conditions

COVID-19; Pulmonary Disease, Chronic Obstructive

Interventions

Contraceptive Devices, Female

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Contraceptive Devices; Equipment and Supplies

Study Officials

• Eman Rashad, Assistant lecturer

  Horus University in Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Rashad, Assistant lecturer

CONTACT

+201011431165; eali@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: May 19, 2022
• Study Start: June 1, 2022
• Primary Completion: October 15, 2022
• Study Completion: November 15, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

EG (1)