Clinical trial NCT05382780: 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
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
COPD
Lead sponsor: Horus University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assessment of change in Physical Fitness Index (PFI)
timeFrame: at baseline and 3 months of intervention
measure: Assessment of change in Rate Pressure Product
timeFrame: at baseline and 3 months of intervention
measure: Assessment of change in Forced vital capacity
timeFrame: at baseline and 3 months of intervention
measure: Assessment of change in Forced expiratory volume in the first one second
timeFrame: at baseline and 3 months of intervention
measure: Assessment of change in Ratio of forced expiratory volume in the first one second to the forced vital capacity of lungs
timeFrame: at baseline and 3 months of intervention
measure: Assessment of change in Maximum voluntry ventilation
timeFrame: at baseline and 3 months of intervention
measure: Assessment of change in Forced vital capacity expressed as percentage of the predicted FVC
timeFrame: at baseline and 3 months of intervention
measure: Assessment of change in Forced expiratory volume in the first one second expressed as percentage of the predicted FEV1
timeFrame: at baseline and 3 months of intervention
Secondary outcomes:
measure: Assessment of change in Oxygen saturation
timeFrame: at baseline and 3 months of intervention
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt
Study officials:
affiliation: Horus University in Egypt
name: Eman Rashad, Assistant lecturer
role: PRINCIPAL_INVESTIGATOR
References: