Effect of Swallowing Rehabilitation Complemented With Nutritional Treatment on the Nutritional Status of Oropharyngeal Dysphagia Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oropharyngeal Dysphagia
- Sponsor
- Hospital General de Mexico
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Nutritional intervention and swallowing rehabilitation on nutritional status of OD patients
- Last Updated
- 6 years ago
Overview
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.
Investigators
Nallely Bueno Hernández
Investigator In Medical Science B
Hospital General de Mexico
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
Outcomes
Primary Outcomes
Nutritional intervention and swallowing rehabilitation on nutritional status of OD patients
Time Frame: Participants will be evaluated at weeks 1, 6 and 12
Changes from baseline anthropometric, biochemical, and body composition values, at 12 weeks of nutritional intervention in OD patients
Secondary Outcomes
- Anthropometric measurements(Participants will be evaluated at weeks 1, 6 and 12)
- Gastrointestinal symptoms(Participants will be evaluated at weeks 1, 6 and 12)
- Electrolytes blood levels(Participants will be evaluated at weeks 1 and 12)
- Swallowing capacity(Participants will be evaluated at weeks 1, 6 and 12)
- Nutritional Risk(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)
- Dietary intake(Participants will be evaluated at weeks 1, 6 and 12)
- Blood quemistry(Participants will be evaluated at weeks 1 and 12)
- Blood chemistry(Participants will be evaluated at weeks 1 and 12)