Clinical trial NCT04132271: Swallowing and Nutritional Treatment on OD Patients
Official title: Effect of Swallowing Rehabilitation Complemented With Nutritional Treatment on the Nutritional Status of Oropharyngeal Dysphagia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oropharyngeal Dysphagia
Keywords: oropharyngeal, dysphagia, nutrition
Lead sponsor: Hospital General de Mexico
Sponsor class: OTHER_GOV
First posted: 2019-10-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Nutritional intervention and swallowing rehabilitation on nutritional status of OD patients
timeFrame: Participants will be evaluated at weeks 1, 6 and 12
Secondary outcomes:
measure: Swallowing capacity
timeFrame: Participants will be evaluated at weeks 1, 6 and 12
measure: Body composition analysis
timeFrame: Participants will be evaluated at weeks 1, 6 and 12
measure: Quality of life
timeFrame: Participants will be evaluated at weeks 1, 6 and 12
measure: Anthropometric measurements
timeFrame: Participants will be evaluated at weeks 1, 6 and 12
measure: Nutritional Risk
timeFrame: Participants will be evaluated at weeks 1, 6 and 12
measure: Gastrointestinal symptoms
timeFrame: Participants will be evaluated at weeks 1, 6 and 12
measure: Dietary intake
timeFrame: Participants will be evaluated at weeks 1, 6 and 12
measure: Blood quemistry
timeFrame: Participants will be evaluated at weeks 1 and 12
measure: Blood chemistry
timeFrame: Participants will be evaluated at weeks 1 and 12
measure: Electrolytes blood levels
timeFrame: Participants will be evaluated at weeks 1 and 12
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Nallely Bueno Hernandez
state: Cuauhtemoc
Study officials:
References: