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

NCT ID: NCT06191367

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2024-02-29

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.

Conditions

Lung Fibrosis Interstitial; Post-COVID-19 Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Aerobic Exercises

Intervention Type: OTHER

Aerobic Exercises

Traditional Chest Physiotherapy

Intervention Type: OTHER

1. Breathing exercise.

2. Postural drainage.

3. Percussion.

4. Coughing.

5. Vibration.

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).

Group Type: EXPERIMENTAL

Incentive Spirometer Device

Intervention Type: 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.

Traditional Chest Physiotherapy

Intervention Type: OTHER

1. Breathing exercise.

2. Postural drainage.

3. Percussion.

4. Coughing.

5. Vibration.

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.

Group Type: ACTIVE_COMPARATOR

Traditional Chest Physiotherapy

Intervention Type: OTHER

1. Breathing exercise.

2. Postural drainage.

3. Percussion.

4. Coughing.

5. Vibration.

Interventions

Aerobic Exercises

Aerobic Exercises

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Traditional Chest Physiotherapy

1. Breathing exercise.

2. Postural drainage.

3. Percussion.

4. Coughing.

5. Vibration.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

McCarious Nahad Aziz Abdelshaheed Stephens

OTHER

Sponsor Role: lead

Responsible Party

McCarious Nahad Aziz Abdelshaheed Stephens

Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mohamed H Elgendy, Doctoral

Role: PRINCIPAL_INVESTIGATOR

Physiotherapy Faculty, Cairo University.

Locations

Physiotherapy department Police Academy Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

CairoU post-covid PF Rehab

Identifier Type: -

Identifier Source: org_study_id