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Post COVID-19 Pulmonary Rehabilitation Program (COVID19REHAB)

Primary Purpose

Covid19, COVID-19 Respiratory Infection, Lung Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
Centro Universitário de Anapolis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID-19, Pulmonary Rehabilitation, Pulmonary Function, Respiratory Physiotherapy, Respiratory Insufficiency

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Universitário de Anápolis - UniEVANGÉLICARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Post COVID-19 Outpatient Pulmonary Rehabilitation Program

Post COVID-19 Home Pulmonary Rehabilitation Program

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 8, 2021
Last Updated
July 28, 2021
Sponsor
Centro Universitário de Anapolis
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1. Study Identification

Unique Protocol Identification Number
NCT04982042
Brief Title
Post COVID-19 Pulmonary Rehabilitation Program
Acronym
COVID19REHAB
Official Title
Outpatient and Home Pulmonary Rehabilitation Program for Post COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitário de Anapolis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Post COVID-19 Outpatient Pulmonary Rehabilitation Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Post COVID-19 Home Pulmonary Rehabilitation Program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional status after Pulmonary Rehabilitation Program (COVID-19REHAB)
Description
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.
Time Frame
12 weeks
Title
Exercise capacity after Pulmonary Rehabilitation Program (COVID-19REHAB)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Forced Vital Capacity after Pulmonary Rehabilitation Program (COVID-19REHAB)
Description
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.
Time Frame
12 weeks
Title
Forced Expiratory Volume in first second after Pulmonary Rehabilitation Program (COVID-19REHAB)
Description
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.
Time Frame
12 weeks
Title
Inspiratory muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB)
Description
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.
Time Frame
12 weeks
Title
Peripheral muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB)
Description
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.
Time Frame
12 weeks
Title
Levels of anxiety and depression after Pulmonary Rehabilitation Program (COVID-19REHAB)
Description
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.
Time Frame
12 weeks
Title
Quality of Life after Pulmonary Rehabilitation Program (COVID-19REHAB)
Description
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.
Time Frame
12 weeks
Title
Health costs after COVID - 19.
Description
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.
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis LV Oliveira, PhD
Phone
0055 62 999052309
Email
oliveira.lvf@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luis VF Oliveira, PhD
Phone
0055 62 999052309
Email
luis.oliveira@unievangelica.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis VF OLiveira, PhD
Organizational Affiliation
Evangelical University of Goiás - UNIEVANGELICA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Universitário de Anápolis - UniEVANGÉLICA
City
Anápolis
State/Province
GO
ZIP/Postal Code
75083-515
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis VF Oliveira, PhD
Phone
+55 62 33106600
Ext
6717
Email
oliveira.lvf@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Clinical and demographic data of patients involved in this study will be made available to other researchers as requested.
IPD Sharing Time Frame
After 02 years
IPD Sharing 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.
IPD Sharing URL
https://www4.unievangelica.edu.br/ppg/movimento-humano-e-reabilitacao/laboratorios
Links:
URL
https://www4.unievangelica.edu.br/ppg/movimento-humano-e-reabilitacao/laboratorios
Description
This is the link to the Pulmonary Rehabilitation Laboratory where this clinical study will be developed.

Learn more about this trial

Post COVID-19 Pulmonary Rehabilitation Program

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