Clinical trial NCT06191367: Effect of Aerobic Exercises Versus Incentive Spirometer Device on Post-covid Pulmonary Fibrosis Patients
Official title: Effect of Aerobic Exercises Versus Incentive Spirometer Device on Post-covid Pulmonary Fibrosis Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Fibrosis Interstitial
Post-COVID-19 Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2024-01-05
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of this study will be to investigate the effect of aerobic exercises vs incentive spirometer device on post-covid patients with residual lung diseases.

Detailed description: To our knowledge, there have been no enough studies that investigated the effect of aerobic exercise and incentive spirometer in pulmonary rehabilitation on post-covid syndrome patients.

Therefore, this study may open up ways to other researchers to investigate and build up on this effect if present and address such an important issue.

The finding of this proposed work may help patients with post-covid syndrome and complain of lung diseases by addressing their complains of symptoms like chest pain, dyspnea, and cough and provide a possible solution to enhance their quality of life and increase their participation in daily life activities.

Patients of post-covid syndrome with residual lung problems will be recruited after approval of ethical committee of the faculty of physical therapy, Cairo university. All participants will sign a written informed consent form.

The subjects will be randomly assigned into one of three groups:

* Group I (experimental) will receive aerobic exercises program and traditional chest physiotherapy.
* Group II (experimental) will receive incentive spirometer device treatment and traditional chest physiotherapy.
* Group III (control) will receive traditional chest physiotherapy only. The measures will be taken before and after treatment program.

Eligibility criteria: Inclusion Criteria:

* Hemodynamic stable (MAP not less than 60mmHg, systolic pressure \>80mmHg and diastolic pressure not \<60mmHg)
* Age from 40 to 85 years.
* Both sexes.
* All patients were positive covid-19 infected patients and passed at least 4 weeks after confirmation.
* All patients suffer from respiratory complications.
* All patients included are actively breathing.
* All patients included are fully aware and conscious.

Exclusion Criteria:

* Hemodynamic Instability.
* Severe Head Injury.
* Increased intracranial pressure.
* Anemic Hb\<8.
* Active Smoking.
* Severe Bronchospasm.
* Low BP (systole \<80, diastole \<60).
* Subcutaneous Emphysema.
* Rip Fractures.
* Untreated Pneumothorax.

Primary outcomes:
measure: Pulmonary function tests (PFTs).
timeFrame: Before and After the treatment program. "8 weeks"
measure: Peripheral oxygen saturation level (SpO2).
timeFrame: Before and After the treatment program. "8 weeks"
measure: Six minutes' walk distance test (6MWD).
timeFrame: Before and After the treatment program. "8 weeks"
measure: Heart rate measurements. (HR).
timeFrame: through all the treatment procedures. "8 weeks"
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Physiotherapy department Police Academy Hospital
Study officials:
affiliation: Physiotherapy Faculty, Cairo University.
name: Mohamed H Elgendy, Doctoral
role: PRINCIPAL_INVESTIGATOR
References: