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

Sponsor
Fayoum University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05476835
Collaborator
(none)
100
1
2
12
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: respiratory exercises - incentive spirometer - walking
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effect of Pulmonary Rehabilitation Program on Post Hospitalization Severe COVID- 19 Patients
Actual Study Start Date :
May 15, 2021
Actual Primary Completion Date :
May 15, 2022
Actual Study Completion Date :
May 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. improvement in dyspnea scale [6 weeks]

    modified medical research council scale (mMRC)

  2. improvement in spirometry measures [6 weeks]

    forced vital capacity measurement in spirometry

Secondary Outcome Measures

  1. improvement in oxygen saturation and 6 minute walk test [6 weeks]

    oxygen saturation before and after 6 minute walk test

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fayoum University Hospital Fayoum Egypt

Sponsors and Collaborators

  • Fayoum University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Enas Sayed Farhat, Fayoum University Hospital, Fayoum University Hospital
ClinicalTrials.gov Identifier:
NCT05476835
Other Study ID Numbers:
  • no: 170 session 82
First Posted:
Jul 27, 2022
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022