Swallowing and Nutritional Treatment on OD Patients

NCT ID: NCT04132271

Last Updated: 2019-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-03
• Study Completion Date: 2020-12-30

Brief Summary

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.

Detailed Description

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.

Methodology: This is a prospective randomized controlled clinical trial, in which OD patients will be recruited to participate. The participants will be receiving swallowing rehabilitation by a specialist phoniatrician. They will be randomise assigned to a special nutritional treatment during 12 weeks. Swallowing rehabilitation, laboratory analyses, anthropometric measurements and consume and quality of life questionaries will be carried out.

Conditions

Oropharyngeal Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Personalized diet

Personalized diet during the swallowing rehabilitation

Group Type: EXPERIMENTAL

Personalized diet

Intervention Type: OTHER

Modified texture and volumen diet according to the OD specifications

Control

Nutritional recommendations during the swallowing rehabilitation

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

Nutritional Recommendations according to the OD specifications

Interventions

Personalized diet

Modified texture and volumen diet according to the OD specifications

Intervention Type: OTHER

Control

Nutritional Recommendations according to the OD specifications

Intervention Type: OTHER

Other Intervention Names

Nutritional Recommendations

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital General de Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Nallely Bueno Hernández

Investigator In Medical Science B

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nallely Bueno Hernandez

Mexico City, Cuauhtemoc, Mexico

Countries

Mexico

Other Identifiers

DI/19/301/03/003

Identifier Type: -

Identifier Source: org_study_id