Effect of Pulmonary Rehabilitation Program on Post Hospitalization Severe COVID- 19 Patients

NCT ID: NCT05476835

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2022-05-15

Brief Summary

COVID-19 infection was discovered to be the major global cause of a serious respiratory illness toward the end of 2019. The majority of COVID-19 patients experience mild disease, while about 14% go on to have severe disease and 6% end up in critical condition. An evidence-based standard of therapy called pulmonary rehabilitation includes exercise training, education, and behavior modification to help people with lung illness feel better physically and mentally.

The aim of the study to evaluate the effect of pulmonary rehabilitation program on severe post covid19 patients (post hospitalization) regarding pulmonary function tests and dyspnea score.

Detailed Description

SARS CoV-2 infection has caused substantial death, morbidity, and unprecedented strain on the world's healthcare systems . When the illness is minor, it typically takes two weeks from the onset of symptoms till recovery, and when it is severe or critical, it may take three to six weeks. It should be mentioned that approximately 75% to 80% of hospitalized patients will remain there for more than 21 days .

After the virus is defeated, COVID-19 can have serious aftereffects on the patient, with bilateral pneumonia. As a result, physiotherapy is essential in this pandemic and will play a major role in helping many patients' health. A 20-30% reduction in pulmonary capacity has already been reported in recent studies .

Although pulmonary rehabilitation has been suggested following severe COVID-19, there is a lack of data showing effectiveness on recovery of physical and psychosocial parameters in severe COVID-19 patients following hospitalization.

The aim of the study is to evaluate the effect of pulmonary rehabilitation program on severe post covid19 patients (post hospitalization) regarding pulmonary function tests and dyspnea score.

50 patients were enrolled in the study post hospitalization due to severe COVID 19 infection. Dyspnea score, Spirometry and 6minute walk test were performed upon discharge. Pulmonary rehabilitation program was performed. Follow up assessment of the same parameters was done 6 weeks after the program.

These results were compared with another 50 patients who were admitted in hospital due to severe COVID 19 infection but no pulmonary rehabilitation program was performed to them after hospitalization.

Conditions

Post COVID-19 Condition

Study Design

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

Study Groups

experimental group (group A) - control group (groupB)

The experimental group (group A) performed respiratory exercises (in form of diaphragmatic breathing, pursed lip breathing exercise and incentive spirometer), rehab exercise program and walking exercise.

Group Type: EXPERIMENTAL

respiratory exercises - incentive spirometer - walking

Intervention Type: COMBINATION_PRODUCT

respiratory exercises (in form of diaphragmatic breathing, pursed lip breathing exercise and incentive spirometer), rehab exercise program and walking exercise.

control group (group B)

The control group (group B) did not receive any physical therapy program

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

respiratory exercises - incentive spirometer - walking

respiratory exercises (in form of diaphragmatic breathing, pursed lip breathing exercise and incentive spirometer), rehab exercise program and walking exercise.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Age range between 50 and 70 years.
• Severe COVID infection.
• Impaired pulmonary function tests post COVID infection.

Exclusion Criteria

• Mild or moderate COVID infection.
• Normal pulmonary function tests post COVID infection
• Chronic chest disease
• End organ failure (sever heart disease-neurodegenerative disease- sever stroke)
• Unstable angina, myocardial infarction, angioplasty, heart surgery in the previous 3 months
• Chronic renal impairments.
• Epistaxis, active haemoptysis
• Recent facial, oral, or skull surgery or trauma.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Enas Sayed Farhat

Fayoum University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asmaa M Younis, doctorate

Role: STUDY_CHAIR

Fayoum University Hospital

Locations

Fayoum University Hospital

Al Fayyum, , Egypt

Countries

Egypt

Other Identifiers

no: 170 session 82

Identifier Type: -

Identifier Source: org_study_id