Covid19COVID19REHABNCT04982042
Post COVID-19 Pulmonary Rehabilitation Program
A study testing Pulmonary Rehabilitation in people with Covid19 and COVID-19 Respiratory Infection, run by Centro Universitário de Anapolis at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Covid19, COVID-19 Respiratory Infection, Lung Diseases
- What is being tested?
- Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2021to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hospitalized patients
- Patients who present clinical instability
- Patients who do not commit to adhering to the Pulmonary Rehabilitation Program
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro Universitário de Anápolis - UniEVANGÉLICA
Anápolis, Goiás, 75083-515
Luis VF Oliveira, PhD, +55 62 33106600 ext. 6717, oliveira.lvf@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Covid19, COVID-19 Respiratory Infection, Lung Diseases, Respiratory Insufficiency, Muscle Weakness, Anxiety Disorder; Mixed With Depression (Mild)
- Being tested
- Pulmonary Rehabilitation
- Keywords
- COVID-19, Pulmonary Rehabilitation, Pulmonary Function, Respiratory Physiotherapy, Respiratory Insufficiency
- Medical subject headings
- COVID-19, Lung Diseases, Respiratory Insufficiency, Muscle Weakness, Anxiety Disorders, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (7)
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.
Measured: 12 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Mar 2021
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitário de Anapolis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Vicente Franco de Oliveira, Centro Universitário de Anapolis
- Investigators
- Luis VF OLiveira, PhD, Principal investigator, Evangelical University of Goiás - UNIEVANGELICA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982042
- Sponsor's protocol ID
- COVID-19 PULMONARY REHAB
- Acronym
- COVID19REHAB
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical and demographic data of patients involved in this study will be made available to other researchers as requested.
Publications
Oliveira MC, Capodaglio P, Paixao HNC, Fonseca AL, Alves LR, Ribeiro Junior JBS, Oliveira RF, Fernandes TV, Marconi DG, Andraus RAC, Oliveira DAAP, Oliveira CS, Silva CHM, Guedes OA, Freitas Junior WR, Oliveira LVF. Effects of an outpatient pulmonary rehabilitation program on exercise capacity, muscle fatigue, dyspnea, and functional status in post-COVID-19 patients: non-randomized clinical trial. Front Rehabil Sci. 2026 Sep 16;7:1921478. doi: 10.3389/fresc.2026.1921478. eCollection 2026.
PubMed 42819381
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient and Home Pulmonary Rehabilitation Program for Post COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04982042
- Acronym / sponsor ID
- COVID19REHAB / COVID-19 PULMONARY REHAB
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centro Universitário de AnapolisUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Post COVID-19 Outpatient Pulmonary Rehabilitation Program | Experimental | Other: Pulmonary RehabilitationThe 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 | Other: Pulmonary RehabilitationThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Hospitalized patients
- Patients who present clinical instability
- Patients who do not commit to adhering to the Pulmonary Rehabilitation Program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary RehabilitationThe 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. | Other | Post COVID-19 Home Pulmonary Rehabilitation Program, Post COVID-19 Outpatient Pulmonary Rehabilitation Program |
Primary outcome
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.
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.
7 secondary outcomes
Forced Vital Capacity after Pulmonary Rehabilitation Program (COVID-19REHAB)
Time frame: 12 weeks
Forced Expiratory Volume in first second after Pulmonary Rehabilitation Program (COVID-19REHAB)
Time frame: 12 weeks
Inspiratory muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB)
Time frame: 12 weeks
Peripheral muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB)
Time frame: 12 weeks
Levels of anxiety and depression after Pulmonary Rehabilitation Program (COVID-19REHAB)
Time frame: 12 weeks
Quality of Life after Pulmonary Rehabilitation Program (COVID-19REHAB)
Time frame: 12 weeks
Health costs after COVID - 19.
Time frame: 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Derived from this study: PubMed 42819381Oliveira MC, Capodaglio P, Paixao HNC, Fonseca AL, Alves LR, Ribeiro Junior JBS, Oliveira RF, Fernandes TV, Marconi DG, Andraus RAC, Oliveira DAAP, Oliveira CS, Silva CHM, Guedes OA, Freitas Junior WR, Oliveira LVF. Effects of an outpatient pulmonary rehabilitation program on exercise capacity, muscle fatigue, dyspnea, and functional status in post-COVID-19 patients: non-randomized clinical trial. Front Rehabil Sci. 2026 Sep 16;7:1921478. doi: 10.3389/fresc.2026.1921478. eCollection 2026.
- This is the link to the Pulmonary Rehabilitation Laboratory where this clinical study will be developed.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Clinical and demographic data of patients involved in this study will be made available to other researchers as requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis VF OLiveira, PhD principal investigator
Evangelical University of Goiás - UNIEVANGELICA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation in people with Covid19 and COVID-19 Respiratory Infection, run by Centro Universitário de Anapolis at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis LV Oliveira, PhD (0055 62 999052309, oliveira.lvf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional status after Pulmonary Rehabilitation Program (COVID-19REHAB) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04982042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.