Influence of Modified Diet, Exercise and Electrical Swallowing Muscle Stimulation on Swallowing Function and Quality of Life in Elderly Patients With Oropharyngeal Dysphagia

Oropharyngeal Dysphagia Clinical Trial

Official title:

Influence of Modified Diet, Exercise and Electrical Swallowing Muscle Stimulation on Swallowing Function and Quality of Life in Elderly Patients With Oropharyngeal Dysphagia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05325658
• Other study ID #: 2.3
• Status: Enrolling by invitation
• Start date: May 21, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: April 2022
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Tasks of biomedical research:

1. To determine the severity of oropharyngeal dysphagia and the risk of aspiration in elderly patients.

2. To evaluate the quality of life of older patients with oropharyngeal dysphagia by performing validation of the Lithuanian version of the quality of life questionnaires in patients with oropharyngeal dysphagia.

3. To evaluate the severity of oropharyngeal dysphagia in elderly patients, the risk of aspiration, and quality of life after interventions.

Data on the sex, age and disease of the swallowing disorder will be collected. No processing of other personal data and health indicators is planned. All data will be collected in questionnaires. The data will be depersonalized by giving the patient a code.

The results and conclusions of the research will be described in the doctoral dissertation and will be used for scientific articles.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients 60 years of age and older;

• Swallowing disorder suspected during hospitalization - oropharyngeal dysphagia;

• Patient's written consent.

Exclusion Criteria:

• severe oropharyngeal dysphagia (when feeding into the stomach through a nasogastric tube is required);

• Significant respiratory or heart failure: dyspnoea (respiratory rate> 20 rpm, SpO2 <90%), tachycardia (HR> 100 rpm);

• very severe malnutrition (severe exhaustion, severe signs of sarcopenia);

• final stage of oncological disease;

• severe dementia (Short Mental Test (MMSE) <10 points);

• Ingestion assessment with a fibroendoscope (FEES) did not reveal any swallowing problems (no dysphagia).

Related Conditions & MeSH terms

• Deglutition Disorders
• Oropharyngeal Dysphagia

Intervention

Other:
• FEES, treatment with modified diet, electrical swallowing muscle stimulation.
Endoscopic swallowing assessment (FEES) consists of three parts:1) assessment of mouth, throat anatomy and more; 2) the patient is given to swallow a certain amount and consistency of liquids and solid food. 3) evaluated: preparation of the bolus for swallowing, aspiration. An 8-point Penetration-Aspiration scale is described.Swallowing exercises. Swallowing exercises are also used in practice, which can help coordinate the swallowing muscles or stimulate the nerves involved in the swallowing reflex.Transcutaneous electrical stimulation is a method of treating dysphagia in which weak electrical impulses stimulate the muscles in the neck area associated with swallowing. In patients with oropharyngeal dysphagia, patients have great difficulty swallowing water of normal consistency or other non-thick liquids, so they should be thickened with special thickeners to such an extent that the patient does not experience discomfort and be able to swallow.

Locations

Country	Name	City	State
Lithuania	Margarita Rugaitiene	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the influence of modified diet, exercise and electrical swallowing muscle stimulation on swallowing function and quality of life in elderly patients with oropharyngeal dysphagia.	Primary outcomes focus on domains within reduction in the severity of oropharyngeal dysphagia and a reduction in the risk of aspiration after administration of a modified diet, electrical swallowing muscle stimulation and exercise to improve swallowing, after 10 days. The Penetration - Aspiration (J.C. Rosenbek et al., 1996) scale will be used before and after treatment to evaluate FEES. Assessing FEES: The higher the score, the more severe the disease.	2021-2024
Primary	Evaluation of the influence of modified diet, exercise and electrical swallowing muscle	Dysphagia Handicap Index (DHI): The higher the score, the more severe oropharyngeal dysphagia.	2021-2024
Primary	Evaluation of the influence of modified diet, exercise and electrical swallowing muscle	SWAL-QoL / SWAL-CARE: frequency scale (in questions 3, 5, 6, 9) and an evaluation scale (in questions 1, 2, 4, 7, 8), in the form of a 5-point Likert scale, where 1 corresponds to worst QoL and 5 to best QoL.	2021-2024