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

Primary Purpose

Covid-19, Pneumonia, SARS Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Pulmonary Physiotherapy Techniques
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19 focused on measuring Pulmonary Physiotherapy, 2019 novel coronavirus disease, COVID-19, Rehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Imam Khomeini Hospital Complex

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pulmonary Physiotherapy Techniques group

Control group

Arm Description

Pulmonary physiotherapy techniques, 6 sessions during 3 days and incentive spirometer.

Incentive spirometer only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mortality rate
The number of dead subjects compared to total patients
Number of participants with Rehospitalization
Patients' hospitalization after discharge due to any reason
The Health-Related Quality of Life (HRQOL)
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.
breathlessness
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.
breathlessness
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.

Full Information

First Posted
April 13, 2020
Last Updated
May 30, 2020
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04357340
Brief Title
The Effects of Pulmonary Physiotherapy Treatments on Patients With COVID-19
Official Title
Efficacy of Pulmonary Physiotherapy on Hospitalized Patients With Novel Coronavirus 2019 Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 2, 2020 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19, Pneumonia, SARS Pneumonia
Keywords
Pulmonary Physiotherapy, 2019 novel coronavirus disease, COVID-19, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All the enrolled participants will be allocated to the intervention of control groups using blocked-balanced randomization method.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary Physiotherapy Techniques group
Arm Type
Experimental
Arm Description
Pulmonary physiotherapy techniques, 6 sessions during 3 days and incentive spirometer.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Incentive spirometer only
Intervention Type
Other
Intervention Name(s)
Pulmonary Physiotherapy Techniques
Intervention Description
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).
Primary Outcome Measure Information:
Title
Mixed venous O2 pressure (PVO2)
Description
Partial pressure of oxygen in mixed venous blood.
Time Frame
Baseline
Title
Mixed venous O2 pressure (PVO2)
Description
Partial pressure of oxygen in mixed venous blood.
Time Frame
Day 3
Title
Mixed venous CO2 pressure (PVCO2)
Description
Partial pressure of carbon dioxide in mixed venous blood.
Time Frame
Baseline
Title
Mixed venous CO2 pressure (PVCO2)
Description
Partial pressure of carbon dioxide in mixed venous blood.
Time Frame
Day 3
Title
PH
Description
Measure of the venous blood acidity or alkalinity
Time Frame
Baseline
Title
PH
Description
Measure of the venous blood acidity or alkalinity
Time Frame
Day 3
Title
HCO3
Description
The amount of bicarbonate ion in the venous blood
Time Frame
Baseline
Title
HCO3
Description
The amount of bicarbonate ion in the venous blood
Time Frame
Day 3
Title
Oxygen saturation (O2 Sat) from VBG
Description
The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood
Time Frame
Baseline
Title
Oxygen saturation (O2 Sat) from VBG
Description
The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood
Time Frame
Day 3
Title
Three minute walk test
Description
The distance a patient can walk during three minute
Time Frame
Baseline
Title
Three minute walk test
Description
The distance a patient can walk during three minute
Time Frame
Day 3
Title
O2 Sat after one minute walking
Time Frame
Baseline
Title
O2 Sat after one minute walking
Time Frame
Day 3
Title
O2 Sat after two minutes use of Partial Rebreather
Time Frame
Baseline
Title
O2 Sat after two minutes use of Partial Rebreather
Time Frame
Day 3
Title
O2 Sat after two minutes free air breathing
Time Frame
Baseline
Title
O2 Sat after two minutes free air breathing
Time Frame
Day 3
Title
O2 sat/ Fio2
Time Frame
Baseline
Title
O2 sat/ Fio2
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Mortality rate
Description
The number of dead subjects compared to total patients
Time Frame
until one month
Title
Number of participants with Rehospitalization
Description
Patients' hospitalization after discharge due to any reason
Time Frame
until one moth
Title
The Health-Related Quality of Life (HRQOL)
Description
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.
Time Frame
One month after end of intervention
Title
breathlessness
Description
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.
Time Frame
Baseline
Title
breathlessness
Description
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.
Time Frame
Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Javaherian, Ph.D. cand.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imam Khomeini Hospital Complex
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
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The Effects of Pulmonary Physiotherapy Treatments on Patients With COVID-19

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