Nutritional Status and Muscle Function in Ambulatory Multiple Sclerosis Patients With Dysphagia
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
-
-
şehitkamil
-
Gaziantep, şehitkamil, Tyrkiet (Türkiye), 27500
- Sanko Unıversıtesı
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 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
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Body weight and height
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- hakanpolat18
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .