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Clinical Trials/NCT04357340
NCT04357340
Completed
N/A

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

Tehran University of Medical Sciences1 site in 1 country40 target enrollmentApril 2, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Covid-19
Sponsor
Tehran University of Medical Sciences
Enrollment
40
Locations
1
Primary Endpoint
Three minute walk test
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
April 2, 2020
End Date
May 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammad Javaherian

PhD. Candidate of Phyiotherapy

Tehran University of Medical Sciences

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Three minute walk test

Time Frame: Day 3

The distance a patient can walk during three minute

Mixed venous O2 pressure (PVO2)

Time Frame: Day 3

Partial pressure of oxygen in mixed venous blood.

Mixed venous CO2 pressure (PVCO2)

Time Frame: Day 3

Partial pressure of carbon dioxide in mixed venous blood.

PH

Time Frame: Day 3

Measure of the venous blood acidity or alkalinity

HCO3

Time Frame: Day 3

The amount of bicarbonate ion in the venous blood

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

O2 Sat after one minute walking

Time Frame: Day 3

O2 Sat after two minutes use of Partial Rebreather

Time Frame: Day 3

O2 Sat after two minutes free air breathing

Time Frame: Day 3

O2 sat/ Fio2

Time Frame: Day 3

Secondary Outcomes

  • Mortality rate(until one month)
  • Number of participants with Rehospitalization(until one moth)
  • The Health-Related Quality of Life (HRQOL)(One month after end of intervention)
  • breathlessness(Day 3)

Study Sites (1)

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