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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Exercise Capacity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Exercise Capacity
时间窗: Baseline and 6 weeks after ISMT and Sham
Cardiopulmonary exercise testing
Blood pressure
时间窗: Baseline and 6 weeks after ISMT and Sham
Sphygmomanometry
Muscle sympathetic nerve activity
时间窗: Baseline and 6 weeks after ISMT and Sham
Microneurography
Endothelial function
时间窗: Baseline and 6 weeks after ISMT and Sham
Doppler Ultrasound
Arterial stiffness
时间窗: Baseline and 6 weeks after ISMT and Sham
Applanation tonometry
Maximum inspiratory pressure
时间窗: Baseline and 6 weeks after ISMT and Sham
Manovacuometry
次要结局
- Nitric oxide(Baseline and 6 weeks after ISMT and Sham)
- Oxidative stress(Baseline and 6 weeks after ISMT and Sham)
- Inflammatory profile(Baseline and 6 weeks after ISMT and Sham)
