Swallowing and Nutritional Treatment on OD Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oropharyngeal Dysphagia

Intervention / Treatment
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* Other: Personalized diet
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized diet<br>Personalized diet during the swallowing rehabilitation | Other: Personalized diet<br>* Modified texture and volumen diet according to the OD specifications<br>|
| Active Comparator: Control<br>Nutritional recommendations during the swallowing rehabilitation | Other: Control<br>* Nutritional Recommendations according to the OD specifications<br>* Other names: Nutritional Recommendations;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oropharyngeal, dysphagia, nutrition