Swallowing and Nutritional Treatment on OD Patients (OD)

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

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.

Study Overview

• Status: Unknown
• Conditions: Oropharyngeal Dysphagia
• Intervention / Treatment: Other: Personalized diet; Other: Control

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.

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Cuauhtemoc
    • Mexico City, Cuauhtemoc, Mexico, 06720
      • Nallely Bueno Hernández

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized diet; Personalized diet during the swallowing rehabilitation	Other: Personalized diet; Modified texture and volumen diet according to the OD specifications
Active Comparator: Control; Nutritional recommendations during the swallowing rehabilitation	Other: Control; Nutritional Recommendations according to the OD specifications; Other Names: Nutritional Recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional intervention and swallowing rehabilitation on nutritional status of OD patients	Changes from baseline anthropometric, biochemical, and body composition values, at 12 weeks of nutritional intervention in OD patients	Participants will be evaluated at weeks 1, 6 and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing capacity	Changes from baseline of the presence or absence of food remains in the larynx and aspiration during the Fibroendoscopic Evaluation of Swallowing at 12 weeks of nutritional intervention in OD patients	Participants will be evaluated at weeks 1, 6 and 12
Body composition analysis	Changes from baseline of the percentage of body fat, muscle and water at 12 weeks of nutritional intervention, using RJL System IV	Participants will be evaluated at weeks 1, 6 and 12
Quality of life	Changes from baseline of WHOQOL- BREF questionary score (the higher score, the higher quality of life represents) at 12 weeks of nutritional intervention in OD patients	Participants will be evaluated at weeks 1, 6 and 12
Anthropometric measurements	Changes from baseline of arm, waist and hips circumferences in centimeters at 12 weeks of nutritional intervention in OD patients	Participants will be evaluated at weeks 1, 6 and 12
Nutritional Risk	Changes from baseline of malnutrition risk during the Malnutrition Universal Screening Tool score (0 = low risk; 1= medium risk 2= high risk) at 12 weeks of nutritional intervention in OD patients.	Participants will be evaluated at weeks 1, 6 and 12
Gastrointestinal symptoms	Changes from baseline in the presence or absence of gastrointestinal symptoms according to the ROME III criteria at 12 weeks of nutritional intervention in OD patients	Participants will be evaluated at weeks 1, 6 and 12
Dietary intake	Changes from baseline of grams of macronutrients (carbohydrates, lipids and protein) consumed, according to the 24 hours record at 12 weeks of nutritional intervention in OD patients	Participants will be evaluated at weeks 1, 6 and 12
Blood quemistry	Changes from baseline glucose, creatinine, high density lipoproteins, low density lipoproteins, cholesterol levels (mg/dL) at 12 weeks of nutritional intervention in OD patients	Participants will be evaluated at weeks 1 and 12
Blood chemistry	Changes from baseline calcium, albumin, hemoglobin levels (g/dL) and iron (ug/dL) levels at 12 weeks of nutritional intervention in OD patients	Participants will be evaluated at weeks 1 and 12
Electrolytes blood levels	Changes from baseline sodium and potasium levels (meq/L) at 12 weeks of nutritional intervention in OD patients	Participants will be evaluated at weeks 1 and 12

Collaborators and Investigators

• Sponsor: Hospital General de Mexico

Study record dates

Study Major Dates

• Study Start (Anticipated): December 3, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): October 18, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: oropharyngeal, dysphagia, nutrition
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: DI/19/301/03/003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No