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临床试验/NCT04132271
NCT04132271Unknown不适用

Effect of Swallowing Rehabilitation Complemented With Nutritional Treatment on the Nutritional Status of Oropharyngeal Dysphagia Patients

Hospital General de Mexico2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年12月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
68
试验地点
2
主要终点
Nutritional intervention and swallowing rehabilitation on nutritional status of OD patients

研究概览

简要总结

Dysphagia is a difficulty during the swallowing process (transportation food from the mouth to the stomach. Oropharyngeal Dysphagia (OD) is diagnosed by videofluoroscopy and faringolaringoscopy. OD threatens the efficacy and safety of swallowing, contributing to an increased risk of aspiration and pneumonia. There are different interventions aimed to change and improve the physiology of swallowing; however, OD can be an important predictor of the progression of malnutrition in different types of patients. Malnutrition is defined as an acute or chronic disease whereby an energy imbalance, lack of energy, protein or other nutrients causes measurable and adverse effects on body composition, functional and clinical outcomes. In addition, it leads to a decrease in the quality of life.

Objective: To establish a strategy of nutritional treatment and swallowing rehabilitation in patients with dysphagia.

Hypothesis: An adequate nutritional intervention in content and consistency, combined with swallowing rehabilitation in patients with dysphagia, will improve the nutritional status and clinical evolution of patients with dysphagia.

详细描述

Introduction: Dysphagia is a difficulty during the swallowing process (transportation food from the mouth to the stomach. Oropharyngeal Dysphagia (OD) is diagnosed by videoflouroscopy and faringolaringoscopy and it is frequently associated with neurodegenerative problems. OD threatens the efficacy and safety of swallowing, contributing to an increased risk of aspiration and pneumonia.

Problem statement: There are different interventions aimed to change and improve the physiology of swallowing; however, OD can be an important predictor of the progression of malnutrition in different types of patients. Malnutrition is defined as an acute or chronic disease whereby an energy imbalance, lack of energy, protein or other nutrients causes measurable and adverse effects on body composition, functional and clinical outcomes. In addition, it leads to a decrease in the quality of life.

Justification: It is essential to provide adequate nutritional interventions according to the specifications of the dysphagia in order to improve the nutritional status of these patients, as well to provide adequate early nutritional treatment when changing from tube to oral feeding, focusing on dietary factors that can significantly improve nutrition of the patient. However, there are no studies that evaluate the specific requirements for the nutritional treatment of these patients. By implementing a diet based on improving the safety and efficacy of swallowing in patients with OD, specific nutritional recommendations that impact on the rate of malnutrition and mortality of the different pathologies that present this condition could be established.

Objective: To establish a strategy of nutritional treatment and swallowing rehabilitation in patients with dysphagia.

Hypothesis: An adequate nutritional intervention in content and consistency, combined with swallowing rehabilitation in patients with dysphagia, will improve the nutritional status and clinical evolution of patients with dysphagia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

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

  • Both sexes
  • 18 to 75 years old
  • Diagnosis of dysphagia
  • Full phonological assessment
  • Any federative entity in the country

排除标准

  • Patients with any nephropathy
  • HIV diagnosis
  • Thyroid dysfunction dignosis
  • Gastrostomy feeded patients
  • Patients on chemotherapy
  • Psychogenic Dysphagia

研究组 & 干预措施

Personalized diet

Experimental

Personalized diet during the swallowing rehabilitation

干预措施: Personalized diet (Other)

Control

Active Comparator

Nutritional recommendations during the swallowing rehabilitation

干预措施: Control (Other)

结局指标

主要结局

Nutritional intervention and swallowing rehabilitation on nutritional status of OD patients

时间窗: Participants will be evaluated at weeks 1, 6 and 12

Changes from baseline anthropometric, biochemical, and body composition values, at 12 weeks of nutritional intervention in OD patients

次要结局

  • Anthropometric measurements(Participants will be evaluated at weeks 1, 6 and 12)
  • Gastrointestinal symptoms(Participants will be evaluated at weeks 1, 6 and 12)
  • Electrolytes blood levels(Participants will be evaluated at weeks 1 and 12)
  • Swallowing capacity(Participants will be evaluated at weeks 1, 6 and 12)
  • Nutritional Risk(Participants will be evaluated at weeks 1, 6 and 12)
  • Body composition analysis(Participants will be evaluated at weeks 1, 6 and 12)
  • Quality of life(Participants will be evaluated at weeks 1, 6 and 12)
  • Dietary intake(Participants will be evaluated at weeks 1, 6 and 12)
  • Blood quemistry(Participants will be evaluated at weeks 1 and 12)
  • Blood chemistry(Participants will be evaluated at weeks 1 and 12)

研究者

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

Nallely Bueno Hernández

Investigator In Medical Science B

Hospital General de Mexico

研究点 (2)

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