Clinical trial NCT06091384: Inspiratory Muscle Strength Training in Post-Covid Syndrome
Official title: The Effects of Based-home High-resistance Inspiratory Muscle Training on Neurovascular Control, Blood Pressure, and Exercise Capacity in Patients With Post-COVID-19 Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Abnormalities
Post-COVID-19 Syndrome
Physical Exercise
Lead sponsor: D'Or Institute for Research and Education
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Muscle sympathetic nerve activity
timeFrame: Baseline and 6 weeks after ISMT and Sham
measure: Endothelial function
timeFrame: Baseline and 6 weeks after ISMT and Sham
measure: Arterial stiffness
timeFrame: Baseline and 6 weeks after ISMT and Sham
measure: Blood pressure
timeFrame: Baseline and 6 weeks after ISMT and Sham
measure: Exercise Capacity
timeFrame: Baseline and 6 weeks after ISMT and Sham
measure: Maximum inspiratory pressure
timeFrame: Baseline and 6 weeks after ISMT and Sham
Secondary outcomes:
measure: Oxidative stress
timeFrame: Baseline and 6 weeks after ISMT and Sham
measure: Nitric oxide
timeFrame: Baseline and 6 weeks after ISMT and Sham
measure: Inflammatory profile
timeFrame: Baseline and 6 weeks after ISMT and Sham
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: D'Or Institute of Research and Education
Study officials:
References: