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

NCT ID: NCT05325658

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2023-09-30

Brief 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.

Conditions

Oropharyngeal Dysphagia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Oropharyngeal dysphagia

Patients with oropharyngeal dysphagia. Patients will be examined before and after combination therapy.

FEES, treatment with modified diet, electrical swallowing muscle stimulation.

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Margarita Rugaitiene

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Margarita Rugaitienė

Kaunas, , Lithuania

Countries

Lithuania

Other Identifiers

2.3

Identifier Type: -

Identifier Source: org_study_id