Swallowing and Nutritional Treatment on OD Patients

NCT04132271 | Unknown DMC

• 1 other identifier: DI/19/301/03/003
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharyngeal Dysphagia

Keywords

oropharyngeal, dysphagia, nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Swallowing capacity

  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

• Anthropometric measurements

  Participants will be evaluated at weeks 1, 6 and 12

• Nutritional Risk

  Participants will be evaluated at weeks 1, 6 and 12

Study Arms (2)

Personalized diet

EXPERIMENTAL

Personalized diet during the swallowing rehabilitation

Other: Personalized diet

Control

ACTIVE COMPARATOR

Nutritional recommendations during the swallowing rehabilitation

Other: Control

Interventions

Personalized diet OTHER

Modified texture and volumen diet according to the OD specifications

Personalized diet

Control OTHER

Nutritional Recommendations according to the OD specifications

Also known as: Nutritional Recommendations

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital General de Mexico: lead

Study Sites (1)

Nallely Bueno Hernandez

Mexico City, Cuauhtemoc, 06720, Mexico

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator In Medical Science B

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 18, 2019
• Study Start: December 3, 2019
• Primary Completion: February 1, 2020
• Study Completion: December 30, 2020
• Last Updated: October 18, 2019

Record last verified: 2019-10

Locations

ME (1)