Post COVID-19 Pulmonary Rehabilitation Program

NCT ID: NCT04982042

Last Updated: 2021-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-07-30

Brief Summary

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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

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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.

Conditions

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Covid19 COVID-19 Respiratory Infection Lung Diseases Respiratory Insufficiency Muscle Weakness Anxiety Disorder; Mixed With Depression (Mild)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Only the outcome assessors will be blinded to the data due to the fact that we have a group of patients undergoing the Outpatient Rehabilitation Program and another group of patients undergoing the Home Rehabilitation Program with follow-up by Tele-Rehabilitation

Study Groups

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Post COVID-19 Outpatient Pulmonary Rehabilitation Program

The outpatient Pulmonary Rehabilitation Program will be carried out at the Pulmonary Rehabilitation Laboratory, consisting of a combination of aerobic and strengthening exercises, lasting 12 weeks, with a frequency of 3 times a week, always in the morning. Each session consists 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.

Group Type EXPERIMENTAL

Pulmonary Rehabilitation

Intervention Type OTHER

The Pulmonary Rehabilitation Program consists of a combination of aerobic and strengthening exercises, lasting 12 weeks, with a frequency of 3 times a week, always in the morning. Each session consists 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.

Post COVID-19 Home Pulmonary Rehabilitation Program

The Home Pulmonary Rehabilitation Program will be carried out at the patients' homes, consisting of the same combination of aerobic and strengthening exercises, lasting 12 weeks, 3 times a week, always in the morning. Each session consists 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. Patients will be monitored weekly via whatsapp.

Group Type ACTIVE_COMPARATOR

Pulmonary Rehabilitation

Intervention Type OTHER

The Pulmonary Rehabilitation Program consists of a combination of aerobic and strengthening exercises, lasting 12 weeks, with a frequency of 3 times a week, always in the morning. Each session consists 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.

Interventions

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Pulmonary Rehabilitation

The Pulmonary Rehabilitation Program consists of a combination of aerobic and strengthening exercises, lasting 12 weeks, with a frequency of 3 times a week, always in the morning. Each session consists 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Universitário de Anapolis

OTHER

Sponsor Role lead

Responsible Party

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Luis Vicente Franco de Oliveira

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luis VF OLiveira, PhD

Role: PRINCIPAL_INVESTIGATOR

Evangelical University of Goiás - UNIEVANGELICA

Locations

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Centro Universitário de Anápolis - UniEVANGÉLICA

Anápolis, Goiás, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Luis LV Oliveira, PhD

Role: CONTACT

0055 62 999052309

Luis VF Oliveira, PhD

Role: CONTACT

0055 62 999052309

Facility Contacts

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Luis VF Oliveira, PhD

Role: primary

+55 62 33106600 ext. 6717

Related Links

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https://www4.unievangelica.edu.br/ppg/movimento-humano-e-reabilitacao/laboratorios

This is the link to the Pulmonary Rehabilitation Laboratory where this clinical study will be developed.

Other Identifiers

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COVID-19 PULMONARY REHAB

Identifier Type: -

Identifier Source: org_study_id

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