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

Completed

• Conditions: Oropharyngeal Dysphagia
• Interventions: Other: FEES, treatment with modified diet, electrical swallowing muscle stimulation.

• Registration Number: NCT05325658
• Lead Sponsor: Lithuanian University of Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-21
• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-13
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-14
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oropharyngeal dysphagia	FEES, treatment with modified diet, electrical swallowing muscle stimulation.	Patients with oropharyngeal dysphagia. Patients will be examined before and after combination therapy.

Primary Outcome Measures

Name	Time	Method
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.	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	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.

Trial Locations

Locations (1)

Margarita Rugaitienė; 🇱🇹 Kaunas, Lithuania