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临床试验/NCT06217211
NCT06217211招募中不适用

Assessment of Ventilatory Efficacy in Patients With Fatigue Associated With SARS-CoV2 Infection After Ingestion of Beet Juice

Hospital de Mataró2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月13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
30
试验地点
2
主要终点
CMT

研究概览

简要总结

The lung is the organ most affected by COVID-19. There are patients who successfully overcome the acute COVID-19 infection and their lungs return to a normal state. However, a significant number present dyspnea and fatigue as sequelae without having a pulmonary origin, but with a significant impact on functionality. In our published studies in relation to fatigue in patients with symptoms attributed to persistent COVID, the investigators have shown that there is muscle involvement, observing a decrease in mechanical efficiency. This muscle involvement causes stimulation of ventilation through the ergoreceptors, causing ineffective ventilation. This affectation can be explained by the findings obtained in the muscle biopsies that the investigators have performed, where the investigators observed a splitting of the basement membrane of the capillaries causing an alteration in the diffusion of metabolic substrates and oxygen.

The main objective of our project is to be able to observe the response in ventilatory efficiency in patients with symptoms of post-covid fatigue after ingesting beet juice.

详细描述

Long COVID is a multisystem condition that comprises a set of symptoms following a SARS-CoV-2 infection. At least 65 million people around the world present symptoms associated with persistent COVID, an incidence of 10% of infected people is estimated1. The incidence is estimated at 10-30% of non-hospitalized cases, 50-70% of hospitalized cases2,3, and 10-12% of vaccinated cases4,5. Persistent COVID is associated with all ages and severity of illness in the acute phase, with the highest percentage of diagnoses between the ages of 36 and 50 years, and the majority of cases of persistent COVID are found in non-hospitalized patients with a mild acute illness6, as this population represents the majority of overall COVID-19 cases. The most prevalent symptoms in persistent COVID are fatigue, dyspnea and weakness7.

In our first published study the investigators observed that patients with fatigue after SARS CoA2 infection behaved very similarly to COPD patients, observing a decrease in mechanical efficiency (ME) at the first threshold, second threshold and at maximum consumption. of oxygen during an incremental test8. (Figure 1).

Mechanical efficiency (ME) refers to the ability of an individual to transform oxygen consumption into effective work. In other words, poorer efficiency will increase the percentage of maximum oxygen uptake (VO2max) needed to sustain a given mechanical work. A decrease in ME, indicating that more energy is expended in a given work output, could represent an increased energy cost of respiration during exercise, an altered efficiency in ATP production (ATP produced per O2 consumed), or a higher ATP cost of contraction (ATP consumed by work production)9. Patients with a decreased ME would decrease their performance and, therefore, could be limited in terms of physical activity9.

In our second study, the investigators observed that patients recovered from SARS-CoV-2 but with symptoms of fatigue presented significant muscle dysfunction compared to healthy women with similar characteristics. These findings were corroborated by detecting an increase in VO2sc and a deterioration in ME and ventilatory efficiency during the constant load test10. These results guide us towards a problem of oxygen diffusion in the muscle cell that the investigators are confirming with the findings currently obtained in quadriceps muscle biopsies. The hypothesis of causing an increase in the dilation of muscle capillaries to improve oxygen diffusion made us think about the vasodilator and ergogenic effects of beets.

Beet juice (BRJ) has become increasingly popular among athletes looking to improve sports performance. BRJ contains high concentrations of nitrate, which can be converted to nitric oxide (NO) after consumption. NO has several functions in the human body, including a vasodilatory effect, which reduces blood pressure and increases the delivery of oxygen and nutrients to various organs. BRJ consumption also has an impact on oxygen delivery to skeletal muscles, muscle efficiency, tolerance and endurance and can therefore have a positive impact on sports performance12.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with fatigue after SARS CoV2 infection.
  • Written informed consent signed by the study candidates (see Addendum 1), after receiving complete information about the objectives, techniques and possible consequences of the study.

排除标准

  • Previous cardiovascular, oncological, neuromuscular or metabolic pathologies that could interfere with the results.
  • Significant alcoholism (>80 g/day) or severe malnutrition
  • Chronic treatment with drugs with potential effects on muscle structure and function
  • Patient treated with nitrates
  • Patients diagnosed prior to the infection with fibromyalgia or chronic fatigue.
  • Patient who has a contraindication to carrying out a stress test.
  • Patients allergic to beets

结局指标

主要结局

CMT

时间窗: 1 determination per week for 3 weeks

Maximum Tolerated Load

VO2max

时间窗: 1 determination per week for 3 weeks

maximum oxygen consumption

次要结局

未报告次要终点

研究者

发起方
Hospital de Mataró
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eulogio Pleguezuelos

MD PhD

Hospital de Mataró

研究点 (2)

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