Cardiovascular Abnormalities, Post-COVID-19 Syndrome, Physical Exercise
Conditions
Brief summary
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.
Interventions
Using a handheld device, participants will perform 30 breaths per day at 75% of maximal inspiratory pressure, six days a week, during 6 weeks.
Sponsors
D'Or Institute for Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Post-COVID-19 syndrome * Have been diagnosed with COVID-19 by RT-PCR * Have oxygen saturation ≤ 93% in room air during the acute phase of the COVID-19 * Have received oxygen supply from any device during the acute phase of the COVID-19 * Hospitalization to treat the Covid-19 * Participants in cardiopulmonary rehabilitation or physical conditioning programs
Exclusion criteria
* Pregnant * History of chronic obstructive pulmonary disease or dependence on oxygen support * History of cardiovascular and renal diseases and cancer prior to the COVID-19 diagnosis * Difficulties in moving to the laboratory for assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum inspiratory pressure | Baseline and 6 weeks after ISMT and Sham | Manovacuometry |
| Arterial stiffness | Baseline and 6 weeks after ISMT and Sham | Applanation tonometry |
| Blood pressure | Baseline and 6 weeks after ISMT and Sham | Sphygmomanometry |
| Exercise Capacity | Baseline and 6 weeks after ISMT and Sham | Cardiopulmonary exercise testing |
| Muscle sympathetic nerve activity | Baseline and 6 weeks after ISMT and Sham | Microneurography |
| Endothelial function | Baseline and 6 weeks after ISMT and Sham | Doppler Ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nitric oxide | Baseline and 6 weeks after ISMT and Sham | Blood samples |
| Inflammatory profile | Baseline and 6 weeks after ISMT and Sham | Blood samples |
| Oxidative stress | Baseline and 6 weeks after ISMT and Sham | Blood samples |
Countries
Brazil
Contacts
Primary ContactAllan R Sales, PhD
Backup ContactArtur Sales, Bs
Outcome results
None listed