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

Primary Purpose

Post COVID-19 Condition

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
respiratory exercises - incentive spirometer - walking
Sponsored by
Fayoum University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post COVID-19 Condition

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fayoum University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

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

control group (group B)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

improvement in dyspnea scale
modified medical research council scale (mMRC)
improvement in spirometry measures
forced vital capacity measurement in spirometry

Secondary Outcome Measures

improvement in oxygen saturation and 6 minute walk test
oxygen saturation before and after 6 minute walk test

Full Information

First Posted
July 23, 2022
Last Updated
July 25, 2022
Sponsor
Fayoum University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05476835
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post COVID-19 Condition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group (group A) - control group (groupB)
Arm Type
Experimental
Arm Description
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.
Arm Title
control group (group B)
Arm Type
No Intervention
Arm Description
The control group (group B) did not receive any physical therapy program
Intervention Type
Combination Product
Intervention Name(s)
respiratory exercises - incentive spirometer - walking
Intervention Description
respiratory exercises (in form of diaphragmatic breathing, pursed lip breathing exercise and incentive spirometer), rehab exercise program and walking exercise.
Primary Outcome Measure Information:
Title
improvement in dyspnea scale
Description
modified medical research council scale (mMRC)
Time Frame
6 weeks
Title
improvement in spirometry measures
Description
forced vital capacity measurement in spirometry
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
improvement in oxygen saturation and 6 minute walk test
Description
oxygen saturation before and after 6 minute walk test
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asmaa M Younis, doctorate
Organizational Affiliation
Fayoum University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fayoum University Hospital
City
Fayoum
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
demographic data of patients - dyspnea scale - pulmonary function tests - oxygen saturation before and after study

Learn more about this trial

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

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