Post COVID-19 Pulmonary Rehabilitation Program

Covid19 Clinical Trial

— COVID19REHAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982042
• Other study ID #: COVID-19 PULMONARY REHAB
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: July 2021
• Source: Centro Universitário de Anapolis
• Contact: Luis LV Oliveira, PhD
• Phone: 0055 62 999052309
• Email: oliveira.lvf[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorder; Mixed With Depression (Mild)
• Anxiety Disorders
• Covid19
• Lung Diseases
• Muscle Weakness
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Respiratory Tract Infections

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Brazil	Centro Universitário de Anápolis - UniEVANGÉLICA	Anápolis	GO

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitário de Anapolis

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Forced Expiratory Volume in first second after Pulmonary Rehabilitation Program (COVID-19REHAB)	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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