Nutritional Status and Muscle Function in Ambulatory Multiple Sclerosis Patients With Dysphagia

Официальное название

Evaluation of Nutritional Status and Muscle Function in Ambulatory Patients With Multiple Sclerosis and Dysphagia

Обзор

The aim of this study is to evaluate the relationship between dysphagia severity and indicators of nutritional status and muscle function in ambulatory patients diagnosed with Multiple Sclerosis (MS) who have swallowing difficulties. In patients with MS, the prevalence of swallowing disorders increases with disease duration and greater neurological involvement. Dysphagia may lead to important clinical consequences such as aspiration risk, inadequate oral intake, involuntary weight loss, and reduced quality of life. Swallowing difficulties negatively affect both the adequacy and safety of nutrition, thereby increasing the risk of malnutrition. In addition, reduced energy and protein intake may lead to a decline in muscle strength and functional capacity. However, in the MS population, dysphagia, nutritional status, and muscle function are often evaluated separately, and studies that assess these domains together are limited. There is a need for real-world data in ambulatory MS patients, particularly using age-independent nutritional screening tools and functional muscle assessment tests in combination. This study aims to systematically and multidisciplinary evaluate nutritional status and muscle function in MS patients with dysphagia.

Подробное описание

This study is a cross-sectional observational research conducted in ambulatory patients diagnosed with Multiple Sclerosis (MS) who experience swallowing difficulties. Participants who meet the inclusion criteria will be informed about the study, and written informed consent will be obtained prior to enrollment.

Demographic and clinical data of the participants (such as age, gender, and disease duration) will be recorded. Swallowing function will be assessed using validated dysphagia screening and/or assessment tools.

Nutritional status will be evaluated using standardized nutritional screening tools and/or anthropometric measurements (such as body weight, height, and body mass index). Muscle function will be assessed using functional measures, including handgrip strength and/or other appropriate muscle performance tests.

The collected data will be statistically analyzed to investigate the relationship between dysphagia severity, nutritional status, and muscle function. No invasive procedures will be performed in this study; only observational and measurement-based assessments will be conducted.

Первичные конечные точки

• Body weight and height [Срок оценки: 2 months]
• Eating Assessment Tool-10 (EAT-10) [Срок оценки: 2 months]
• Dysphagia in Multiple Sclerosis (DYMUS) [Срок оценки: 2 months]
• Yale Swallowing Protocol [Срок оценки: 2 months]
• Malnutrition Universal Screening Tool (MUST) [Срок оценки: 2 months]

Критерии участия

Критерии включения

• Be 18 years of age or older
• Have a diagnosis of multiple sclerosis according to the 2017 Revised McDonald criteria
• Have difficulty swallowing (DYMUS >1)
• EDSS score must be available in clinical records
• Possess sufficient cognitive and physical capacity to participate in the questionnaires and assessments to be administered as part of the study

Критерии исключения

• 1\. A recent acute MS relapse or use of high-dose corticosteroids within the past 4 weeks 2. Acute orthopedic or traumatic conditions that prevent the performance of measurements 3. Severe cognitive impairment that prevents understanding or performing the tests 4. Being pregnant or breastfeeding 5. Presence of active malignancy or advanced systemic disease 6. Having any pathology in the cervical region

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Sanko Unıversıtesı — Gaziantep

Идентификаторы

NCT: NCT07564921 · hakanpolat18

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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