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

NCT05325658 | Completed DMC

• 1 other identifier: 2.3
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Tasks of biomedical research:

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

Conditions

Oropharyngeal Dysphagia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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.

Interventions

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.

Oropharyngeal dysphagia

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients 60 years of age and older;
• Swallowing disorder suspected during hospitalization - oropharyngeal dysphagia;
• Patient's written consent.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Margarita Rugaitienė

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Fees and Charges; Therapeutics

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: April 13, 2022
• Study Start: May 21, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

LI (1)