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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357340
• Other study ID #: 99-1-103-47429
• Status: Completed
• Phase: N/A
• Start date: April 2, 2020
• Est. completion date: May 30, 2020

Study information

• Verified date: May 2020
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19
• Pneumonia
• SARS Pneumonia

Intervention

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).

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Khomeini Hospital Complex	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mixed venous O2 pressure (PVO2)	Partial pressure of oxygen in mixed venous blood.	Baseline
Primary	Mixed venous O2 pressure (PVO2)	Partial pressure of oxygen in mixed venous blood.	Day 3
Primary	Mixed venous CO2 pressure (PVCO2)	Partial pressure of carbon dioxide in mixed venous blood.	Baseline
Primary	Mixed venous CO2 pressure (PVCO2)	Partial pressure of carbon dioxide in mixed venous blood.	Day 3
Primary	PH	Measure of the venous blood acidity or alkalinity	Baseline
Primary	PH	Measure of the venous blood acidity or alkalinity	Day 3
Primary	HCO3	The amount of bicarbonate ion in the venous blood	Baseline
Primary	HCO3	The amount of bicarbonate ion in the venous blood	Day 3
Primary	Oxygen saturation (O2 Sat) from VBG	The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood	Baseline
Primary	Oxygen saturation (O2 Sat) from VBG	The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood	Day 3
Primary	Three minute walk test	The distance a patient can walk during three minute	Baseline
Primary	Three minute walk test	The distance a patient can walk during three minute	Day 3
Primary	O2 Sat after one minute walking		Baseline
Primary	O2 Sat after one minute walking		Day 3
Primary	O2 Sat after two minutes use of Partial Rebreather		Baseline
Primary	O2 Sat after two minutes use of Partial Rebreather		Day 3
Primary	O2 Sat after two minutes free air breathing		Baseline
Primary	O2 Sat after two minutes free air breathing		Day 3
Primary	O2 sat/ Fio2		Baseline
Primary	O2 sat/ Fio2		Day 3
Secondary	Mortality rate	The number of dead subjects compared to total patients	until one month
Secondary	Number of participants with Rehospitalization	Patients' hospitalization after discharge due to any reason	until one moth
Secondary	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.	One month after end of intervention
Secondary	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.	Baseline
Secondary	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.	Day 3