The Effects of Pulmonary Physiotherapy Treatments on Patients With COVID-19

May 30, 2020 updated by: Mohammad Javaherian, Tehran University of Medical Sciences

Efficacy of Pulmonary Physiotherapy on Hospitalized Patients With Novel Coronavirus 2019 Pneumonia

The aim of this study is to evaluate the efficacy of pulmonary physiotherapy on respiratory functions in hospitalized patients with Novel Coronavirus 2019 pneumonia. Patients will be randomized into 1) intervention group: receiving pulmonary physiotherapy technique to improve pulmonary function and walking training or 2) control group: Usual medical care. Patients in both groups will receive therapeutic incentive spirometer. Various outcome measurements of pulmonary functions will be evaluated before and after of interventions. Mortality rate, hospitalization duration and re-admission will be followed until one month after end of intervention. Also, patient's quality of life will be measured after one month.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In late December 2019, the new coronavirus (COVID-19) emerged in Wuhan, China and it has been confirmed as the cause of pneumonia in a large number of Chinese patients. The virus, also known as SARS-CoV-2, has since then spread to more than 200 countries worldwide.

The most common symptoms of COVID-19 are fever, dry cough, shortness of breath and tiredness. In severe cases, the infection could cause pneumonia, acute respiratory distress syndrome (ARDS) and sometimes leads to death. Pulmonary physiotherapy is a comprehensive, effective and safe treatment method which is aimed at improving patient's respiratory symptoms, train effective coughing, clear the airway secretion, eliminate exacerbation and so on. It seems that pulmonary physiotherapy interventions can effectively decrease hospitalization, reduce the risk of complications and improve the patient's medical condition.

The aim of this study is to evaluate the effectiveness of the hold breathing technique, chest expansion exercise, postural drainage procedure and Cough techniques carried out during pulmonary physiotherapy sessions.

The researchers will invite 40 hospitalized patients in Imam Khomeini Hospital Complex, Tehran, Iran. All patients will be enrolled after taking informed consent. All of the procedure will be performed with the coordination of the patient's physicians. Patients will be randomized to the intervention or control group. Primary outcome measurements will be evaluated immediately before and after the interventions (with three days period). Also, patient's condition (including process of disease progression, mortality, hospital stay duration and re-admission) will be followed until one month using medical records review and interviewing with the patient or his/her family. Patient's health related quality of life will be measured using short form-36 quality of life assessment tool one month after the end of interventions. Intention-to-treat analysis will be performed in the patients that dropped out of the study.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with COVID-19 pneumonia confirmed by RT-PCR test and diagnostic radiology.
  2. Non-intubated patients
  3. Patients with full consciousness
  4. Be able to walking and performing exercises.
  5. O2 Saturation < 88% when free air breathing.
  6. be able to write and read in Farsi

Exclusion Criteria:

  1. Any type of musculoskeletal disorder disabling patient to participate to study.
  2. Intubation during the period of intervention
  3. Patients' dissatisfaction to continue the study for any reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pulmonary Physiotherapy Techniques group
Pulmonary physiotherapy techniques, 6 sessions during 3 days and incentive spirometer.
Other: Pulmonary Physiotherapy Techniques
Participants will receive pulmonary physiotherapy techniques in six session during three days (twice daily). Four distinguished interventions will be provided for the patients: 1) Chest expansion exercises (for prevention and treatment of potential atelectasis); 2) Techniques to Mobilize or loosen the pulmonary secretions (Active cycle breathing, Coughing techniques, Vibration and Postural drainage); 3) Hold breathing exercise (3 sets, 10 repetition) and; 4) Walking training (based on patient's tolerance until 6 minute).
NO_INTERVENTION: Control group
Incentive spirometer only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mixed venous O2 pressure (PVO2)
Time Frame: Baseline
Partial pressure of oxygen in mixed venous blood.
Baseline
Mixed venous O2 pressure (PVO2)
Time Frame: Day 3
Partial pressure of oxygen in mixed venous blood.
Day 3
Mixed venous CO2 pressure (PVCO2)
Time Frame: Baseline
Partial pressure of carbon dioxide in mixed venous blood.
Baseline
Mixed venous CO2 pressure (PVCO2)
Time Frame: Day 3
Partial pressure of carbon dioxide in mixed venous blood.
Day 3
PH
Time Frame: Baseline
Measure of the venous blood acidity or alkalinity
Baseline
PH
Time Frame: Day 3
Measure of the venous blood acidity or alkalinity
Day 3
HCO3
Time Frame: Baseline
The amount of bicarbonate ion in the venous blood
Baseline
HCO3
Time Frame: Day 3
The amount of bicarbonate ion in the venous blood
Day 3
Oxygen saturation (O2 Sat) from VBG
Time Frame: Baseline
The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood
Baseline
Oxygen saturation (O2 Sat) from VBG
Time Frame: Day 3
The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood
Day 3
Three minute walk test
Time Frame: Baseline
The distance a patient can walk during three minute
Baseline
Three minute walk test
Time Frame: Day 3
The distance a patient can walk during three minute
Day 3
O2 Sat after one minute walking
Time Frame: Baseline
Baseline
O2 Sat after one minute walking
Time Frame: Day 3
Day 3
O2 Sat after two minutes use of Partial Rebreather
Time Frame: Baseline
Baseline
O2 Sat after two minutes use of Partial Rebreather
Time Frame: Day 3
Day 3
O2 Sat after two minutes free air breathing
Time Frame: Baseline
Baseline
O2 Sat after two minutes free air breathing
Time Frame: Day 3
Day 3
O2 sat/ Fio2
Time Frame: Baseline
Baseline
O2 sat/ Fio2
Time Frame: Day 3
Day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: until one month
The number of dead subjects compared to total patients
until one month
Number of participants with Rehospitalization
Time Frame: until one moth
Patients' hospitalization after discharge due to any reason
until one moth
The Health-Related Quality of Life (HRQOL)
Time Frame: One month after end of intervention
Using Short-form 36 questionnaire. The minimum score is 0 and the maximum score is 100. Higher scores mean patient's better quality of life.
One month after end of intervention
breathlessness
Time Frame: Baseline
The amount of shortness of breath using Visual Analogue Scale (VAS). The minimum score is 0 and maximum is 10. The 0 score means no breathlessness and the 10 score is the maximum breathlessness.
Baseline
breathlessness
Time Frame: Day 3
The amount of shortness of breath using Visual Analogue Scale (VAS). The minimum score is 0 and maximum is 10. The 0 score means no breathlessness and the 10 score is the maximum breathlessness.
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 2, 2020

Primary Completion (ACTUAL)

April 30, 2020

Study Completion (ACTUAL)

May 30, 2020

Study Registration Dates

First Submitted

April 13, 2020

First Submitted That Met QC Criteria

April 18, 2020

First Posted (ACTUAL)

April 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2020

Last Update Submitted That Met QC Criteria

May 30, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99-1-103-47429

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underline the results reported in this article, after de-identification

IPD Sharing Time Frame

Beginning 3 months and ending 12 months following article publication

IPD Sharing Access Criteria

Researchers who provide an approved methodologically proposal in the same purpose

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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