Clinical trial NCT04982042: Post COVID-19 Pulmonary Rehabilitation Program
Official title: Outpatient and Home Pulmonary Rehabilitation Program for Post COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
COVID-19 Respiratory Infection
Lung Diseases
Respiratory Insufficiency
Muscle Weakness
Anxiety Disorder; Mixed With Depression (Mild)
Keywords: COVID-19
Pulmonary Rehabilitation
Pulmonary Function
Respiratory Physiotherapy
Respiratory Insufficiency
Lead sponsor: Centro Universitário de Anapolis
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To compare the effects of an Outpatient and Home Pulmonary Rehabilitation Program aimed at patients with pulmonary sequelae resulting from COVID-19 and with other chronic lung diseases on clinical symptoms, level of physical activity, functional status, quality of life, survival and in health maintenance costs by the government.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional status after Pulmonary Rehabilitation Program (COVID-19REHAB)
timeFrame: 12 weeks
measure: Exercise capacity after Pulmonary Rehabilitation Program (COVID-19REHAB)
timeFrame: 12 weeks
Secondary outcomes:
measure: Forced Vital Capacity after Pulmonary Rehabilitation Program (COVID-19REHAB)
timeFrame: 12 weeks
measure: Forced Expiratory Volume in first second after Pulmonary Rehabilitation Program (COVID-19REHAB)
timeFrame: 12 weeks
measure: Inspiratory muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB)
timeFrame: 12 weeks
measure: Peripheral muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB)
timeFrame: 12 weeks
measure: Levels of anxiety and depression after Pulmonary Rehabilitation Program (COVID-19REHAB)
timeFrame: 12 weeks
measure: Quality of Life after Pulmonary Rehabilitation Program (COVID-19REHAB)
timeFrame: 12 weeks
measure: Health costs after COVID - 19.
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Anápolis
country: Brazil
facility: Centro Universitário de Anápolis - UniEVANGÉLICA
state: GO
Study officials:
affiliation: Evangelical University of Goiás - UNIEVANGELICA
name: Luis VF OLiveira, PhD
role: PRINCIPAL_INVESTIGATOR
References: