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

NCT05476835 | Completed

• 1 other identifier: no: 170 session 82
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Post COVID-19 Condition

Outcome Measures

Primary Outcomes (2)

• improvement in dyspnea scale

  modified medical research council scale (mMRC)

  6 weeks

• improvement in spirometry measures

  forced vital capacity measurement in spirometry

  6 weeks

Secondary Outcomes (1)

• improvement in oxygen saturation and 6 minute walk test

  6 weeks

Study Arms (2)

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

EXPERIMENTAL

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.

Combination Product: respiratory exercises - incentive spirometer - walking

control group (group B)

NO INTERVENTION

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

Interventions

respiratory exercises - incentive spirometer - walking COMBINATION_PRODUCT

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

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

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University Hospital

Al Fayyum, Egypt

Location

Study Officials

• Asmaa M Younis, doctorate

  Fayoum University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fayoum University Hospital

Model Details: 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.

Study Record Dates

• First Submitted: July 23, 2022
• First Posted: July 27, 2022
• Study Start: May 15, 2021
• Primary Completion: May 15, 2022
• Study Completion: May 15, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)