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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post COVID-19 Outpatient Pulmonary Rehabilitation Program | Experimental | 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. |
|
| Post COVID-19 Home Pulmonary Rehabilitation Program | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Rehabilitation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional status after Pulmonary Rehabilitation Program (COVID-19REHAB) | 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. | 12 weeks |
| Exercise capacity after Pulmonary Rehabilitation Program (COVID-19REHAB) | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Vital Capacity after Pulmonary Rehabilitation Program (COVID-19REHAB) | Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on the forced vital capacity (FVC) measured by spirometry in patients with pulmonary sequelae resulting from COVID-19. | 12 weeks |
| Forced Expiratory Volume in first second after Pulmonary Rehabilitation Program (COVID-19REHAB) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis LV Oliveira, PhD | Contact | 0055 62 999052309 | oliveira.lvf@gmail.com | |
| Luis VF Oliveira, PhD | Contact | 0055 62 999052309 | luis.oliveira@unievangelica.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Luis VF OLiveira, PhD | Evangelical University of Goiás - UNIEVANGELICA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Universitário de Anápolis - UniEVANGÉLICA | Recruiting | Anápolis | Goiás | 75083-515 | Brazil |
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| Label | URL |
|---|---|
| This is the link to the Pulmonary Rehabilitation Laboratory where this clinical study will be developed. | View source |
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Clinical and demographic data of patients involved in this study will be made available to other researchers as requested.
After 02 years
The clinical and demographic data of the patients involved in this study will be made available to other researchers as requested after the end of the study and for an indefinite period.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D008171 | Lung Diseases |
| D012131 | Respiratory Insufficiency |
| D018908 | Muscle Weakness |
| D001008 | Anxiety Disorders |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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.
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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
|
Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on the forced expiratory volume in first second (FEV1) measured by spirometry in patients with pulmonary sequelae resulting from COVID-19. |
| 12 weeks |
| Inspiratory muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB) | Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on the inspiratory muscles strength measured by vacuometry in patients with pulmonary sequelae resulting from COVID-19. | 12 weeks |
| Peripheral muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB) | Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on the peripheral muscle strength measured by Hand Grip Dynamometer in patients with pulmonary sequelae resulting from COVID-19. | 12 weeks |
| Levels of anxiety and depression after Pulmonary Rehabilitation Program (COVID-19REHAB) | Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on the Anxiety and depression levels measured by the Hospital Anxiety and Depression scale in patients with pulmonary sequelae resulting from COVID-19. | 12 weeks |
| Quality of Life after Pulmonary Rehabilitation Program (COVID-19REHAB) | Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on the Quality of Life levels measured by Medical Outcomes Study/SF-36 Questionnaire in patients with pulmonary sequelae resulting from COVID-19. | 12 weeks |
| Health costs after COVID - 19. | Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on healthcare costs verified through the financial expenses of patients with pulmonary sequelae resulting from COVID-19. | 36 weeks |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001523 | Mental Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |