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

NCT04357340 | Completed DMC

• 1 other identifier: 99-1-103-47429
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19; Pneumonia; SARS Pneumonia

Keywords

Pulmonary Physiotherapy; 2019 novel coronavirus disease; COVID-19; Rehabilitation

Outcome Measures

Primary Outcomes (20)

• Mixed venous O2 pressure (PVO2)

  Partial pressure of oxygen in mixed venous blood.

  Baseline

• Mixed venous O2 pressure (PVO2)

  Partial pressure of oxygen in mixed venous blood.

  Day 3

• Mixed venous CO2 pressure (PVCO2)

  Partial pressure of carbon dioxide in mixed venous blood.

  Baseline

• Mixed venous CO2 pressure (PVCO2)

  Partial pressure of carbon dioxide in mixed venous blood.

  Day 3

• PH

  Measure of the venous blood acidity or alkalinity

  Baseline

• PH

  Measure of the venous blood acidity or alkalinity

  Day 3

• HCO3

  The amount of bicarbonate ion in the venous blood

  Baseline

• HCO3

  The amount of bicarbonate ion in the venous blood

  Day 3

• Oxygen saturation (O2 Sat) from VBG

  The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood

  Baseline

• Oxygen saturation (O2 Sat) from VBG

  The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood

  Day 3

• Three minute walk test

  The distance a patient can walk during three minute

  Baseline

• Three minute walk test

  The distance a patient can walk during three minute

  Day 3

• O2 Sat after one minute walking

  Baseline

• O2 Sat after one minute walking

  Day 3

• O2 Sat after two minutes use of Partial Rebreather

  Baseline

• O2 Sat after two minutes use of Partial Rebreather

  Day 3

• O2 Sat after two minutes free air breathing

  Baseline

• O2 Sat after two minutes free air breathing

  Day 3

• O2 sat/ Fio2

  Baseline

• O2 sat/ Fio2

  Day 3

Secondary Outcomes (5)

• 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

  Baseline

• breathlessness

  Day 3

Study Arms (2)

Pulmonary Physiotherapy Techniques group

EXPERIMENTAL

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

Other: Pulmonary Physiotherapy Techniques

Control group

NO INTERVENTION

Incentive spirometer only

Interventions

Pulmonary Physiotherapy Techniques OTHER

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).

Pulmonary Physiotherapy Techniques group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Imam Khomeini Hospital Complex

Tehran, Iran

Location

Related Publications (18)

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  PMID: 36719885 DERIVED

MeSH Terms

Conditions

COVID-19; Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mohammad Javaherian, Ph.D. cand.

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. Candidate of Phyiotherapy

Model Details: All the enrolled participants will be allocated to the intervention of control groups using blocked-balanced randomization method.

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 22, 2020
• Study Start: April 2, 2020
• Primary Completion: April 30, 2020
• Study Completion: May 30, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 12 months following article publication
• Access Criteria: Researchers who provide an approved methodologically proposal in the same purpose

Locations

IR (1)