Clinical trial NCT05476835: Effect of Pulmonary Rehabilitation Program on Post Hospitalization Severe COVID- 19 Patients
Official title: Effect of Pulmonary Rehabilitation Program on Post Hospitalization Severe COVID- 19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post COVID-19 Condition
Lead sponsor: Fayoum University Hospital
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: improvement in dyspnea scale
timeFrame: 6 weeks
measure: improvement in spirometry measures
timeFrame: 6 weeks
Secondary outcomes:
measure: improvement in oxygen saturation and 6 minute walk test
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University Hospital
Study officials:
affiliation: Fayoum University Hospital
name: Asmaa M Younis, doctorate
role: STUDY_CHAIR
References: