Sarcopenia and Related Factors in Patients With Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSelcuk University
About this trial
Multiple Sclerosis (MS) is a chronic disease affecting the central nervous system, exhibiting autoimmune and neurodegenerative properties. Neurological deficits, mobility limitations, and decreased muscle strength are commonly observed in MS patients as the disease progresses. The literature indicates that low physical activity levels and neurological deficits in individuals with MS can lead to decreased muscle mass and functional losses. Sarcopenia is a condition characterized by decreased skeletal muscle mass and strength associated with aging and chronic diseases, and studies on the prevalence of sarcopenia in MS patients are limited.
Recent studies have revealed a high prevalence of sarcopenia in MS patients, which can have negative effects on physical performance, quality of life, and disease progression. Low muscle mass in MS patients can accelerate the loss of motor function and increase the level of disability. Additionally, nutritional deficiencies and low protein intake seen in MS patients are among the factors that accelerate muscle loss.
Studies examining the relationship between MS and sarcopenia in the literature emphasize the importance of early diagnosis and intervention to improve patients' quality of life and functional independence. Factors such as muscle strength, physical activity level, and nutritional status should be assessed to determine the risk of sarcopenia in MS patients.
This study was designed to determine the prevalence of sarcopenia in patients with Multiple Sclerosis (MS) and to examine the relationship between sarcopenia and fatigue, disability level (EDSS), nutritional status, and physical activity level.
In this context:
* The prevalence of sarcopenia in MS patients will be determined, * The relationship between sarcopenia and muscle strength, physical performance, and body composition will be evaluated, * The effects of nutrition and physical activity on sarcopenia in MS patients will be investigated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being 18 years of age or older,
Having been diagnosed with Multiple Sclerosis (confirmed by a neurologist),
Being in a stable phase of the disease (having not had an attack in the last 3 months),
Having preserved walking ability (EDSS score ≤6.5),
Disqualifiers
Having another neuromuscular disease.
Having developed significant muscle loss within the last 6 months due to use of corticosteroids or immunosuppressive therapy.
Having systemic diseases that can cause muscle loss, such as cancer, rheumatic diseases, or severe metabolic disorders.
Having undergone major surgery or a history of serious trauma within the last 3 months.
Trial population
Individuals with MS who applied to the Selçuk University Faculty of Medicine Hospital MS Living Center
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Clinical Assessments
Other interventionParticipants will undergo the following assessments: * Muscle strength: Handgrip strength test (using a digital dynamometer), * Muscle mass: Bioelectrical impedance analysis (BIA) or DXA, * Physical performance: 6-minute walk test, 5-repetition sit-to-stand test, * Fatigue: Modified Fatigue Impact Scale (MFIS), * Disability: EDSS, * Nutritional status: Mini Nutritional Assessment (MNA), * Physical activity: Godin Leisure-Time Exercise Questionnaire, * Quality of life: MSQoL-54.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: One group (Observational Cohort)1 intervention
Trial outcomes
Primary outcomes
1
Body composition
Body mass and body composition will be measured with the help of Tanita brand device using bioelectrical impedance method. Information provided by the patient, such as height, age, gender, and physical activity level, is manually entered into the device. The device then transmits a very low level, harmless electrical current into the body and automatically analyzes body composition based on the transit time of this current. Parameters to be evaluated in body composition; body mass index (BMI = body mass: (kg)/height2 (m)2), fat mass expressed as a percentage of body mass (pFM), fat-free mass (FFM) expressed in kilograms and appendicular skeletal muscle mass (ASMM) and skeletal muscle mass (SMM) expressed in kilograms. The device automatically provides all the specified parameters during a single measurement. The measurements will be recorded on the previously prepared form.
Time frame
Baseline2
Handgrip Strength
This will be used to assess muscle strength. The validity and reliability of this test has been previously established in the literature.
Time frame
Baseline3
6-Minute Walk Test
This will be administered to assess physical performance. This test has been shown to be valid and reliable in neurological disease populations.
Time frame
6 Minutes4
Mini Nutritional Assessment Form (MNA)
This will be used to assess nutritional status.
Time frame
BaselineSecondary outcomes
1
Demographic data and personal characteristics
Demographic information such as sociodemographic characteristics, medications used, comorbidities, education level, occupation, smoking, alcohol use, past medical history, and family history of the individuals included in the study will be recorded.
Time frame
Baseline2
Godin Leisure Time Exercise Questionnaire
Will be applied to assess the level of physical activity.
Time frame
Baseline3
Expanded Disability Status Scale (EDSS)
This will be administered by a neurologist to determine the level of disability in MS patients.
Time frame
Baseline4
Modified Fatigue Impact Scale (MFIS)
This will be used to assess fatigue levels in MS patients. The validity and reliability of the Turkish version have been previously confirmed.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov