Effect of Aerobic Exercises Versus Incentive Spirometer Device on Post-covid Pulmonary Fibrosis Patients

Post-COVID-19 Syndrome Clinical Trial

Official title:

Effect of Aerobic Exercises Versus Incentive Spirometer Device on Post-covid Pulmonary Fibrosis Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06191367
• Other study ID #: CairoU post-covid PF Rehab
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 2024

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Post-COVID-19 Syndrome
• Pulmonary Fibrosis

Intervention

Other:
• Aerobic Exercises
Aerobic Exercises

Device:
• Incentive Spirometer Device
is a handheld medical device used to help patients improve the functioning of their lungs. By training patients to take slow and deep breaths, this simplified spirometer facilitates lung expansion and strengthening. Patients inhale through a mouthpiece, which causes a piston inside the device to rise. This visual feedback helps them monitor their inspiratory effort. Incentive spirometers are commonly used after surgery or other illnesses to prevent pulmonary complications.

Other:
• Traditional Chest Physiotherapy
Breathing exercise. Postural drainage. Percussion. Coughing. Vibration.

Locations

Country	Name	City	State
Egypt	Physiotherapy department Police Academy Hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
McCarious Nahad Aziz Abdelshaheed Stephens	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function tests (PFTs).	to measure the lungs' capacities and volumes like: FVC, FEV1, and PEF.	Before and After the treatment program. "8 weeks"
Primary	Peripheral oxygen saturation level (SpO2).	measures the amount of oxygen carried in the blood stream in peripheral limbs.	Before and After the treatment program. "8 weeks"
Primary	Six minutes' walk distance test (6MWD).	measures the aerobic capacity of the lungs by testing the maximum distance the subject can walk in a 6 minutes time.	Before and After the treatment program. "8 weeks"
Primary	Heart rate measurements. (HR).	it measures the number of heart bumps in a minute in order to deliver blood to all of the body during Rest and Activity.	through all the treatment procedures. "8 weeks"