跳至主要内容
临床试验/NCT07544186
NCT07544186已完成不适用

Effect of a Non-pharmacological Intervention (Nutritional Therapy and Pulmonary Rehabilitation) on Endothelial Function, Body Composition, and Physical Functionality in Recovered COVID-19 Patients.

Instituto Nacional de Enfermedades Respiratorias1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2020年11月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Endothelial disfunction markers

研究概览

简要总结

This study aims to evaluate the impact of a non-pharmacological treatment (nutritional therapy and pulmonary rehabilitation) on endothelial function, body composition, and physical functionality in recovered COVID-19 patients.

The primary research question is: What is the effect of a non-pharmacological treatment (nutritional therapy and pulmonary rehabilitation) on endothelial function, body composition, and physical capacity in recovered COVID-19 patients, compared to those receiving conventional medical management? A nutritional treatment combined with L-citrulline supplementation (intervention group) will be compared against conventional treatment alone (control group). Both groups will undergo pulmonary rehabilitation for a 3-month follow-up.

Subjects assigned to the intervention group will be required to:

  • Take 4 g of L-citrulline daily for 3 months.
  • Attend an interim session at 1.5 months for review of the nutritional treatment and supplementation.
  • Keep a record of each supplement intake.

详细描述

Coronavirus Disease 2019 (COVID-19), caused by SARS-CoV-2, represents a global public health crisis that has resulted in severe complications and death in more than 500,000 individuals worldwide.

The risk factors for severe COVID-19 include age over 70 years, hypertension, diabetes mellitus, smoking, coronary artery disease, and obesity, which have been associated with endothelial dysfunction (ED). The coexistence of chronic non-communicable diseases significantly exacerbates the inflammatory response, increasing the risk of adverse events and poor prognosis. Similarly, a high probability of cardiovascular diseases in subjects is at elevated risk of severe COVID-19, due to the overexpression of angiotensin-converting enzyme 2. In addition, in our country, the leading causes of death are related to metabolic diseases: 19% of men and women between the ages of 30 and 69 die from cardiovascular diseases, with diabetes ranking as the second leading cause of death. Furthermore, 76.6% of the population is overweight or obese, and 25.5% has hypertension, factors that render our population particularly susceptible to moderate to severe COVID-19.

Moreover, both pharmacological and non-pharmacological treatments have primarily focused on the acute phase of infection. However, it is essential to implement treatment protocols, including pulmonary rehabilitation and nutritional therapy with citrulline supplementation or immunonutrients with anti-inflammatory properties, to prevent Post-Intensive Care Syndrome, reduce systemic inflammation, and improve endothelial function. These interventions may collectively enhance protein synthesis, attenuate muscle mass loss, and promote patient autonomy, functional recovery, and overall quality of life.

Post-COVID-19 syndrome Post-COVID-19 syndrome has been defined as the persistence of symptoms and/or delayed long-term remission of complications arising from SARS-CoV-2 infection, occurring beyond 4 weeks after initial symptom onset.

Nutritional supplementation L-citrulline L-Citrulline is a non-essential, water-soluble alpha-amino acid and a potent endogenous precursor of L-arginine, which increases the bioavailability of NO. In endothelial cells, NO is synthesized from L-arginine by endothelial nitric oxide synthase, yielding NO and L-citrulline.

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
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Recovered COVID-19 patients with a negative PCR test for SARS-CoV-
  • Subjects between 40 and 80 years.
  • Subjects who give written informed consent to participate in the study.

排除标准

  • Subjects diagnosed with Human Immunodeficiency Virus (HIV).
  • Subjects diagnosed with cancer.
  • Subjects with a glomerular filtration rate (GFR) <30 ml/min/1.73 m².
  • Subjects currently enrolled in another interventional study.

研究组 & 干预措施

Intervention group.

Experimental

Intervention group: Subjects will receive conventional medical and nutritional treatment supplemented with 4 g/day L-citrulline supplementation for 3 months, as well as a home-based PR program prescribed by a rehabilitation physician according to each patient's individual needs and physical capacity, specifically for those whose clinical condition does not require attending in-person PR sessions three times per week at INER. Assessments will be conducted at baseline and 3 months.

干预措施: L-citrulline supplementation (Dietary Supplement)

Control group.

No Intervention

Control group: Subjects will receive conventional medical and nutritional treatment, as well as a home-based pulmonary rehabilitation (PR) program prescribed by a rehabilitation physician according to each patient's individual needs and physical capacity, specifically for those whose clinical condition does not require attending in-person PR sessions three times per week at INER. Assessments will be conducted at baseline, and 3 months.

结局指标

主要结局

Endothelial disfunction markers

时间窗: 3 months

E-Selectin, ng/ml was Serum nitric oxide concentration was assessed indirectly through the enzymatic conversion of nitrate to nitrite (pg/ml). sE-Selectin (ng/ml) and Endothelin-1 (ng/ml) levels were measured using a human enzyme-linked immunosorbent assay (ELISA) kit (R\&D Systems, Inc., Minneapolis, MN, USA). ICAM-1 (ng/mg of protein )and VCAM-1 (ng/mg of protein) was assessed using a method is the sandwich enzyme-linked immunosorbent assay (ELISA).

Body composition

时间窗: 3 months

Body composition was measured using whole-body electrical bioimpedance with RJL Systems Quantum single-frequency. Weight was expressed in kilograms, fat-mass in percentage, phase angle in grades, and the appendicular skeletal muscle mass index in kg/m2.

Physical functionality

时间窗: 3 months

Handgrip strength was measured using a mechanical Smedley Hand Dynamometer, this outcome measure was expressed in kilograms. Exercise tolerance was evaluated using a six-minute walk test, the distance covered was expressed in meters. Pulmonary rehabilitation: static and dynamic balance, gait, fall risk, cognitive function, peripheral strength assessed by manual muscle testing, quality of life, anxiety and depression screening, and perceived disability. The results were presented in scores obtained for each test.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dulce González Islas, PhD

Principal Investigator

Instituto Nacional de Enfermedades Respiratorias

研究点 (1)

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