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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Oropharyngeal Dysphagia
• Intervention / Treatment: Other: FEES, treatment with modified diet, electrical swallowing muscle stimulation.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania
    • Margarita Rugaitienė

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Geriatric patients treated at Kaunas Hospital who meet the inclusion criteria.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 2.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No