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COVID-19 is an emerging pandemic disease caused by severe acute respiratory syndrome (SARS-CoV-2). Although the majority of patients infected with SARS-CoV-2 are asymptomatic or have mild symptoms, some patients develop severe symptoms that can protractedly impair their quality of life and functional capacity. SARS-CoV-2 is closely related to severe acute respiratory syndrome (SARS) with direct and indirect effects on several systems, especially the musculoskeletal system, in addition to the respiratory system. Some of these symptoms persist for a long period, called Post-Covid-19 Syndrome, directly interfering with the functional capacity and quality of life of these participants. Cardiopulmonary Rehabilitation exercises are focused on restoring functional capacity in patients affected by cardiopulmonary diseases. The primary objective of this study is to evaluate the clinical and functional effects of a quarterly Cardiopulmonary Rehabilitation exercise program for participants with post-COVID-19 syndrome.
The secondary objectives will be: To compare the effects of a supervised program of 12 weeks of supervised exercises and a program of self-performed home exercises, guided by an exercise booklet, of the same duration on muscle strength and peripheral resistance; Compare the effects of a 12-week supervised exercise program and a self-performed home exercise program, guided by an exercise booklet, of the same duration on levels of fatigue and dyspnea in patients with post-COVID-19 syndrome; Compare the effects of a 12-week supervised exercise program and a self-performed home exercise program, guided by an exercise booklet, of the same duration on health-related quality of life and post-COVID-19 functional status.
This is a randomized, controlled, double-blind treatment trial with a 1:1 allocation ratio.
Participants: Patients will be recruited at the Central Hospital of the Military Police and in the specialized multidisciplinary follow-up outpatient clinic after COVID-19. The participants will be adults (≥18 years and ≤ 65 years), with a previous diagnosis COVID-19, who required hospitalization and need for invasive mechanical ventilation for at least 7 days and who were discharged from the hospital between August and Dec 2021.
Intervention and comparison:
This study will be divided into three groups: control group, face-to-face intervention group and home intervention group. Both groups will be evaluated before and after the study period, however the control group will only receive the treatment offered to the other groups after the end of the study. Physical functions and functional capacity will be evaluated.
After ensuring that patients meet the inclusion criteria, they will be divided into groups that will receive supervised care in a supervised Pulmonary Rehabilitation Center, with protocoled exercises, the other group will receive a booklet of self-explanatory exercises for performing the exercises in home, and the control group that will not receive intervention in this period.
The intervention groups should perform the exercises in the period of 12 weeks, 2 times a week, totaling 24 intervention sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | The control group will not receive intervention during the study. | |
| Face-to-face intervention | Active Comparator | The face-to-face intervention group will perform pulmonary rehabilitation at the professional-oriented Rehabilitation Center. |
|
| Home intervention | Active Comparator | The home intervention group will carry out home intervention through a self-explanatory exercise booklet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary rehabilitation exercises at the Rehabilitation Center | Other | Face-to-face intervention (12 weeks): Using the participants' assessment and personal characteristics, the therapist will prescribe pulmonary rehabilitation exercises that will be performed at the pulmonary rehabilitation center. |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral muscle function I | Will be assessed using the Palm Grip Dynamometry | 12 weeks |
| Peripheral muscle function II | Will be assessed using the Quadriceps Peak Load Test | 12 weeks |
| Peripheral muscle function III | Will be assessed using the Quadriceps Muscle Endurance Test. | 12 weeks |
| Daily living activity | It will be evaluated by the modified Medical Resource Council (mMRC) dyspnea scale | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life improvement | The assessment of quality of life will be carried out using a generic instrument of 36 items, validated in Brazil and called the SF-36 (Short Form Health Survey). | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Carolina Sebastião da Silva | Centro Universitário Augusto Motta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Fisiatria e Reabilitação da PolÃcia Militar- RJ | Rio de Janeiro | Rio de Janeiro | 21073-460 | Brazil |
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Three pre-post assessment groups (control/face-to-face intervention/self-performed home intervention)
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The study will be a clinical trial previously randomized by electronic randomization system (www.random.org) and the allocation of volunteers in the study arms will be done without the participation of the researchers. The study will be double-blind since neither the volunteers nor the professional who will perform the Cardiopulmonary Rehabilitation protocol is aware of the objectives and clinical valences that will be measured by the study.
|
| Home Intervention | Other | Home Intervention (12 weeks): Using the participants' assessment and personal characteristics, the therapist will provide a portfolio of self-explanatory exercises, and guide participants on safety precautions. |
|
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D009043 | Motor Activity |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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