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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Post-COVID-19 Syndrome; Lung Fibrosis Interstitial
• Intervention / Treatment: Other: Aerobic Exercises; Other: Traditional Chest Physiotherapy; Device: Incentive Spirometer Device

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Physiotherapy department Police Academy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (experimental) Aerobic Exercises and Traditional Chest Physiotherapy.; It was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received aerobic exercise techniques which consist of 3 levels of activity exercises and traditional program of chest physiotherapy. (Five times per week for two months).	Other: Aerobic Exercises; Aerobic Exercises; Other: Traditional Chest Physiotherapy; Breathing exercise.; Postural drainage.; Percussion.; Coughing.; Vibration.
Experimental: Group II (experimental)Incentive Spirometer Device and Traditional Chest Physiotherapy.; It was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received incentive spirometer training techniques and traditional program of chest physiotherapy. (Five times per week for two months).	Other: Traditional Chest Physiotherapy; Breathing exercise.; Postural drainage.; Percussion.; Coughing.; Vibration.; 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.
Active Comparator: Group III (control) will receive Traditional Chest Physiotherapy only.; As a control group it was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received traditional program of chest physiotherapy only. (Five times per week for two months). for example: - Breathing Exercises. - Postural Drainage. - Percussion. - Coughing - Vibration.	Other: Traditional Chest Physiotherapy; Breathing exercise.; Postural drainage.; Percussion.; Coughing.; Vibration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary function tests (PFTs).	to measure the lungs' capacities and volumes like: FVC, FEV1, and PEF.	Before and After the treatment program. "8 weeks"
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"
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"
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"

Collaborators and Investigators

• Sponsor: McCarious Nahad Aziz Abdelshaheed Stephens
• Collaborators: Cairo University
• Investigators: Principal Investigator: Mohamed H Elgendy, Doctoral, Physiotherapy Faculty, Cairo University.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: December 23, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis
• Other Study ID Numbers: CairoU post-covid PF Rehab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No