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

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.

Study Overview

• Status: Completed
• Conditions: Post COVID-19 Condition
• Intervention / Treatment: Combination product: respiratory exercises - incentive spirometer - walking

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt
    • Fayoum University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Combination product: 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.
NO_INTERVENTION: control group (group B); The control group (group B) did not receive any physical therapy program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement in oxygen saturation and 6 minute walk test	oxygen saturation before and after 6 minute walk test	6 weeks

Collaborators and Investigators

• Sponsor: Fayoum University Hospital
• Investigators: Study Chair: Asmaa M Younis, doctorate, Fayoum University hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2021
• Primary Completion (ACTUAL): May 15, 2022
• Study Completion (ACTUAL): May 15, 2022

Study Registration Dates

• First Submitted: July 23, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (ACTUAL): July 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: no: 170 session 82

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: demographic data of patients - dyspnea scale - pulmonary function tests - oxygen saturation before and after study

Drug and device information, study documents

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