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

27 de abril de 2026 atualizado por: Hakan Polat, Sanko University

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

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.

Visão geral do estudo

Status

Inscrevendo-se por convite

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

34

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • şehitkamil
      • Gaziantep, şehitkamil, Turquia (Türkiye), 27500
        • Sanko Unıversıtesı

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra de Probabilidade

População do estudo

MS patients with swallowing difficulties

Descrição

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Body weight and height
Prazo: 2 months
These will be measured in accordance with standard anthropometric measurement protocols. Height will be measured using a stadiometer with participants standing in the Frankfurt plane. Body weight will be measured with a calibrated digital scale accurate to 0.1 kg. Body mass index (BMI) will be calculated by dividing body weight in kilograms by the square of height in meters.
2 months
Eating Assessment Tool-10 (EAT-10)
Prazo: 2 months
Developed by Belafsky and colleagues , this is a 10-item self-report scale that assesses the severity of dysphagia as perceived by the patient. Each item is scored on a scale of 0-4, and the total score ranges from 0 to 40. A total score of 3 or higher indicates a clinically significant risk of dysphagia. The validity and reliability of the scale in Turkish were established by Demir and colleagues.
2 months
Dysphagia in Multiple Sclerosis (DYMUS)
Prazo: 2 months
Dysphagia in Multiple Sclerosis (DYMUS): DYMUS is a 10-item self-administered questionnaire requiring "yes/no" responses, developed to assess symptoms and signs of swallowing difficulties specific to multiple sclerosis (MS) in relation to solid and liquid foods. The validity and reliability study of the Turkish version was conducted by Arslan and colleagues, and it has been demonstrated that the Turkish version is a valid and reliable tool for assessing dysphagia in patients with MS.
2 months
Yale Swallowing Protocol
Prazo: 2 months
A standardized swallowing screening test developed to assess the risk of aspiration and the safety of oral feeding in individuals with swallowing disorders. The protocol focuses specifically on determining the risk of aspiration during fluid intake and is used as a quick and reliable screening tool in clinical practice. The test consists of a structured procedure requiring the individual to drink approximately 90 mL (3 ounces) of water without interruption.
2 months
Malnutrition Universal Screening Tool (MUST)
Prazo: 2 months
MUST is a short, practical, and age-independent nutritional screening tool developed to identify the risk of malnutrition in adults. It consists of three components: Body Mass Index (BMI), unintentional weight loss in the past 3-6 months, and the impact of acute illness or inability to eat. Based on the total score, individuals are classified as having low, moderate, or high risk of malnutrition. British Association for Parenteral and Enteral.
2 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de fevereiro de 2026

Conclusão Primária (Real)

15 de abril de 2026

Conclusão do estudo (Estimado)

1 de maio de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

27 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de abril de 2026

Primeira postagem (Real)

4 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de abril de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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