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Patients with post-Covid-19 syndrome are at high risk of developing cardiovascular diseases 12 months after acute infection of COVID-19. We recently revealed that these patients have elevated muscular sympathetic nerve activity (MSNA), vascular dysfunction, impaired cardiac diastolic function, and reduced functional capacity. Considering that these outcomes are independent predictors of cardiovascular mortality, it is urgent to restore the cardiovascular health of these patients. High resistance inspiratory muscle strength training (IMST) at 75% of pressure inspiratory (PImax) performed at home (5 min/session, 5-7 times/week per 6 weeks) reduces the MSNA, improves the endothelial function and lowers blood pressure in different populations. Based on these findings, IMST (75% PImax) is an excellent therapeutic option for patients with post-COVID-19 syndrome. Therefore, the aim of the present proposal is to test whether IMST (75% PImax) reduces sympathetic activity, improves vascular function, and restores cardiac function, evoking an increase in functional capacity in patients with post-COVID-19 syndrome. To test these hypotheses we will conduct a randomized, double-blind, sham-controlled clinical trial to test these hypotheses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Experimental | Using a handheld device, participants will perform 30 breaths a day at 75% of maximal inspiratory pressure, six days a week, for 6 weeks. |
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| Sham- Inspiratory Muscle Training | Sham Comparator | Using a handheld device, participants will perform 30 breaths a day at 15% of maximal inspiratory pressure, six days a week, for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory muscle strength training | Other | Using a handheld device, participants will perform 30 breaths per day at 75% of maximal inspiratory pressure, six days a week, during 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle sympathetic nerve activity | Microneurography | Baseline and 6 weeks after ISMT and Sham |
| Endothelial function | Doppler Ultrasound | Baseline and 6 weeks after ISMT and Sham |
| Arterial stiffness | Applanation tonometry | Baseline and 6 weeks after ISMT and Sham |
| Blood pressure | Sphygmomanometry | Baseline and 6 weeks after ISMT and Sham |
| Exercise Capacity | Cardiopulmonary exercise testing | Baseline and 6 weeks after ISMT and Sham |
| Maximum inspiratory pressure | Manovacuometry | Baseline and 6 weeks after ISMT and Sham |
| Measure | Description | Time Frame |
|---|---|---|
| Oxidative stress | Blood samples | Baseline and 6 weeks after ISMT and Sham |
| Nitric oxide | Blood samples | Baseline and 6 weeks after ISMT and Sham |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allan R Sales, PhD | Contact | 55 21 996482036 | allan.sales@idor.org | |
| Artur Sales, Bs | Contact | 55 11 970921084 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| D'Or Institute of Research and Education | Recruiting | São Paulo | 04501-000 | Brazil |
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| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D000094024 | Post-Acute COVID-19 Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000086382 | COVID-19 |
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| Inflammatory profile | Blood samples | Baseline and 6 weeks after ISMT and Sham |
| 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 |