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

NCT06191367 | Unknown

• 1 other identifier: CairoU post-covid PF Rehab
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Fibrosis Interstitial; Post-COVID-19 Syndrome

Outcome Measures

Primary Outcomes (4)

• 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"

Study Arms (3)

Group I (experimental) Aerobic Exercises and Traditional Chest Physiotherapy.

EXPERIMENTAL

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; Other: Traditional Chest Physiotherapy

Group II (experimental)Incentive Spirometer Device and Traditional Chest Physiotherapy.

EXPERIMENTAL

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).

Device: Incentive Spirometer Device; Other: Traditional Chest Physiotherapy

Group III (control) will receive Traditional Chest Physiotherapy only.

ACTIVE COMPARATOR

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

Interventions

Aerobic Exercises OTHER

Aerobic Exercises

Group I (experimental) Aerobic Exercises and Traditional Chest Physiotherapy.

Incentive Spirometer Device 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.

Group II (experimental)Incentive Spirometer Device and Traditional Chest Physiotherapy.

Traditional Chest Physiotherapy OTHER

1. Breathing exercise. 2. Postural drainage. 3. Percussion. 4. Coughing. 5. Vibration.

Group I (experimental) Aerobic Exercises and Traditional Chest Physiotherapy.; Group II (experimental)Incentive Spirometer Device and Traditional Chest Physiotherapy.; Group III (control) will receive Traditional Chest Physiotherapy only.

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McCarious Nahad Aziz Abdelshaheed Stephens: lead
• Cairo University: collaborator

Study Sites (1)

Physiotherapy department Police Academy Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Pulmonary Fibrosis; Post-Acute COVID-19 Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Post-Infectious Disorders; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mohamed H Elgendy, Doctoral

  Physiotherapy Faculty, Cairo University.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 5, 2024
• Study Start: February 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)