Post COVID-19 Pulmonary Rehabilitation Program

NCT04982042 | Unknown DMC

• 1 other identifier: COVID-19 PULMONARY REHAB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Forced Vital Capacity after Pulmonary Rehabilitation Program (COVID-19REHAB)

  12 weeks

• Forced Expiratory Volume in first second after Pulmonary Rehabilitation Program (COVID-19REHAB)

  12 weeks

• Inspiratory muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB)

  12 weeks

• Peripheral muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB)

  12 weeks

• Levels of anxiety and depression after Pulmonary Rehabilitation Program (COVID-19REHAB)

  12 weeks

Study Arms (2)

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.

Other: Pulmonary Rehabilitation

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.

Other: Pulmonary Rehabilitation

Interventions

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.

Post COVID-19 Home Pulmonary Rehabilitation Program; Post COVID-19 Outpatient Pulmonary Rehabilitation Program

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hospitalized patients
• Patients who present clinical instability
• Patients who do not commit to adhering to the Pulmonary Rehabilitation Program

Sponsors & Collaborators

• Centro Universitário de Anapolis: lead

Study Sites (1)

Centro Universitário de Anápolis - UniEVANGÉLICA

Anápolis, Goiás, 75083-515, Brazil

RECRUITING

Related Links

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

MeSH Terms

Conditions

COVID-19; Lung Diseases; Respiratory Insufficiency; Muscle Weakness; Anxiety Disorders; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Diseases; Respiration Disorders; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Luis VF OLiveira, PhD

  Evangelical University of Goiás - UNIEVANGELICA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 29, 2021
• Study Start: March 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: July 30, 2022
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After 02 years
• Access Criteria: 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.

Locations

BR (1)