Clinical trial NCT04357340: 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
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19
Pneumonia
SARS Pneumonia
Keywords: Pulmonary Physiotherapy
2019 novel coronavirus disease
COVID-19
Rehabilitation
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All the enrolled participants will be allocated to the intervention of control groups using blocked-balanced randomization method.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mixed venous O2 pressure (PVO2)
timeFrame: Baseline
measure: Mixed venous O2 pressure (PVO2)
timeFrame: Day 3
measure: Mixed venous CO2 pressure (PVCO2)
timeFrame: Baseline
measure: Mixed venous CO2 pressure (PVCO2)
timeFrame: Day 3
measure: PH
timeFrame: Baseline
measure: PH
timeFrame: Day 3
measure: HCO3
timeFrame: Baseline
measure: HCO3
timeFrame: Day 3
measure: Oxygen saturation (O2 Sat) from VBG
timeFrame: Baseline
measure: Oxygen saturation (O2 Sat) from VBG
timeFrame: Day 3
measure: Three minute walk test
timeFrame: Baseline
measure: Three minute walk test
timeFrame: Day 3
measure: O2 Sat after one minute walking
timeFrame: Baseline
measure: O2 Sat after one minute walking
timeFrame: Day 3
measure: O2 Sat after two minutes use of Partial Rebreather
timeFrame: Baseline
measure: O2 Sat after two minutes use of Partial Rebreather
timeFrame: Day 3
measure: O2 Sat after two minutes free air breathing
timeFrame: Baseline
measure: O2 Sat after two minutes free air breathing
timeFrame: Day 3
measure: O2 sat/ Fio2
timeFrame: Baseline
measure: O2 sat/ Fio2
timeFrame: Day 3
Secondary outcomes:
measure: Mortality rate
timeFrame: until one month
measure: Number of participants with Rehospitalization
timeFrame: until one moth
measure: The Health-Related Quality of Life (HRQOL)
timeFrame: One month after end of intervention
measure: breathlessness
timeFrame: Baseline
measure: breathlessness
timeFrame: Day 3
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Khomeini Hospital Complex
Study officials:
affiliation: Tehran University of Medical Sciences
name: Mohammad Javaherian, Ph.D. cand.
role: PRINCIPAL_INVESTIGATOR
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