- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04982042
Post COVID-19 Pulmonary Rehabilitation Program (COVID19REHAB)
Outpatient and Home Pulmonary Rehabilitation Program for Post COVID-19 Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luis LV Oliveira, PhD
- Phone Number: 0055 62 999052309
- Email: oliveira.lvf@gmail.com
Study Contact Backup
- Name: Luis VF Oliveira, PhD
- Phone Number: 0055 62 999052309
- Email: luis.oliveira@unievangelica.edu.br
Study Locations
-
-
GO
-
Anápolis, GO, Brazil, 75083-515
- Recruiting
- Centro Universitário de Anápolis - UniEVANGÉLICA
-
Contact:
- Luis VF Oliveira, PhD
- Phone Number: 6717 +55 62 33106600
- Email: oliveira.lvf@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced Vital Capacity after Pulmonary Rehabilitation Program (COVID-19REHAB)
Time Frame: 12 weeks
|
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)
Time Frame: 12 weeks
|
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)
Time Frame: 12 weeks
|
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)
Time Frame: 12 weeks
|
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)
Time Frame: 12 weeks
|
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)
Time Frame: 12 weeks
|
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.
Time Frame: 36 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luis VF OLiveira, PhD, Evangelical University of Goiás - UNIEVANGELICA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- COVID-19
- Lung Diseases
- Muscle Weakness
- Respiratory Insufficiency
- Anxiety Disorders
- Respiratory Tract Infections
Other Study ID Numbers
- COVID-19 PULMONARY REHAB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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