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Clinical Trials/NCT04982042
NCT04982042
Unknown
Not Applicable

Outpatient and Home Pulmonary Rehabilitation Program for Post COVID-19 Patients

Centro Universitário de Anapolis1 site in 1 country40 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Centro Universitário de Anapolis
Enrollment
40
Locations
1
Primary Endpoint
Exercise capacity after Pulmonary Rehabilitation Program (COVID-19REHAB)
Last Updated
4 years ago

Overview

Brief Summary

Coronavirus-2019 disease (COVID-19) is a highly infectious respiratory disease that causes respiratory, physical and psychological dysfunction in patients.

With the increased understanding of the severity of COVID-19 and clinical evidence in accordance with the opinions of first-line clinical experts involved in the treatment of this epidemic, the investigators believe that the participation of patients with sequelae of COVID-19 in a Pulmonary Rehabilitation Program would be of utmost importance.

According to recent scientific recommendations for patients with sequelae of COVID-19, respiratory rehabilitation would alleviate symptoms of dyspnea, anxiety and depression and, eventually, improve physical functions and quality of life.

Therefore, it is essential to anticipate early rehabilitation after the acute phase of ARDS, in order to limit the severity of the effects of the ICU and promote rapid functional recovery. Physiotherapy will play a role in providing exercise, mobilization and rehabilitation interventions for survivors of critical illnesses associated with COVID-19, in order to enable a functional social return.

Detailed Description

The investigatores propose a clinical, prospective and consecutive study composed of participants with pulmonary sequelae of COVID-19 and pulmonary diseases such as COPD, Asthma, Bronchitis, Emphysema, Bronchiectasis and pulmonary fibrosis. Initially, all patients will undergo a physical assessment, pulmonary function tests and nutritional assessment, in addition to applying the modified dyspnea scale of the MMRC (Modified Medical Research Council) and the 6-minute walk test (6MWT), according to the standards recommended by the American Thoracic Society (ATS). The proposed Outpatient and Home Pulmonary Rehabilitation Program is based on the Guidelines recommended by the Brazilian Society of Pulmonology (SBPT) and by the Global Initiative for Chronic Obstructive Lung Disease (GOLD), with a minimum duration of 12 weeks, frequency of 3 weekly sessions, accompanied by health professionals in this field. Patients who seek care at municipal and state health services in the city of Anápolis, (Goiás) will be recruited. Patients with clinically stabilized COVID - 19 sequelae will be considered eligible, and who agree to participate in the study, signing the Informed Consent . The outpatient PRP consisted of a combination of aerobic and strengthening exercises, lasting 12 weeks, frequency 3 times a week. Each session will consist of active warm-up exercises, upper and lower limb strengthening, aerobic conditioning and stretching exercises. The warm-up phase consists of intercalated calisthenic exercises for different muscle groups, according to each patient's tolerance.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
July 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centro Universitário de Anapolis
Responsible Party
Principal Investigator
Principal Investigator

Luis Vicente Franco de Oliveira

Principal investigator

Centro Universitário de Anapolis

Eligibility Criteria

Inclusion Criteria

  • Patients with a diagnosis of pulmonary sequelae post COVID-19
  • Patients clinically stabilized
  • Who agreed to participate in the clinical study, signing the informed consent form, will be considered eligible.

Exclusion Criteria

  • Hospitalized patients
  • Patients who present clinical instability
  • Patients who do not commit to adhering to the Pulmonary Rehabilitation Program

Outcomes

Primary Outcomes

Exercise capacity after Pulmonary Rehabilitation Program (COVID-19REHAB)

Time Frame: 12 weeks

Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on exercise capacity assessed with the six minutes Walk Test ( 6MWT) in patients with pulmonary sequelae resulting from COVID-19.

Functional status after Pulmonary Rehabilitation Program (COVID-19REHAB)

Time Frame: 12 weeks

Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on levels of functional status assessed with the Medical Research Council (MRC) Scale in patients with pulmonary sequelae resulting from COVID-19.

Secondary Outcomes

  • Peripheral muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB)(12 weeks)
  • Levels of anxiety and depression after Pulmonary Rehabilitation Program (COVID-19REHAB)(12 weeks)
  • Health costs after COVID - 19.(36 weeks)
  • Quality of Life after Pulmonary Rehabilitation Program (COVID-19REHAB)(12 weeks)
  • Inspiratory muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB)(12 weeks)
  • Forced Vital Capacity after Pulmonary Rehabilitation Program (COVID-19REHAB)(12 weeks)
  • Forced Expiratory Volume in first second after Pulmonary Rehabilitation Program (COVID-19REHAB)(12 weeks)

Study Sites (1)

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