跳至主要内容
临床试验/NCT06091384
NCT06091384招募中不适用

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

D'Or Institute for Research and Education2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月16日最近更新:
适应症

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

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)

研究者

发起方
D'Or Institute for Research and Education
申办方类型
Other
责任方
Sponsor

研究点 (2)

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