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

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.

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Key information

Conditions

Oropharyngeal Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

60 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Margarita Rugaitienė

Kaunas, Lithuania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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.

Primary outcomes

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.

Time frame: 2021-2024

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.
Evaluation of the influence of modified diet, exercise and electrical swallowing muscle

Time frame: 2021-2024

Dysphagia Handicap Index (DHI): The higher the score, the more severe oropharyngeal dysphagia.
Evaluation of the influence of modified diet, exercise and electrical swallowing muscle

Time frame: 2021-2024

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.

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Apr 13, 2022
Registry last updated: Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed