- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07564830
Association Between Sarcopenia, Fatigue and Orthostatic Intolerance in Geriatric Patients: A Case Control Study
This study aims to explore the relationship between sarcopenia, fatigue, and orthostatic intolerance in older adults. It will be conducted among geriatric patients attending Ain Shams University Hospitals.
Participants aged 65 years and older will be divided into two groups: those with sarcopenia, diagnosed according to the European Working Group on Sarcopenia in Older People 2, and age- and sex-matched controls without sarcopenia. The study will compare levels of fatigue and the presence of orthostatic intolerance between the two groups.
The findings are expected to improve understanding of how sarcopenia is associated with fatigue and orthostatic symptoms in the elderly population, which may help guide better clinical assessment and management.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This case-control study aims to investigate the association between sarcopenia, fatigue, and orthostatic intolerance among older adults. The study will be conducted on geriatric patients attending Ain Shams University Hospitals outpatient clinics and inpatient services.
Participants aged 65 years and older will be recruited and categorized into two groups: patients diagnosed with sarcopenia according to the European Working Group on Sarcopenia in Older People 2 criteria, and age- and sex-matched controls without sarcopenia. Sampling will be performed using a simple random sampling technique.
All participants will undergo a comprehensive geriatric assessment, including detailed medical history taking (with emphasis on comorbidities, medication use, and history of falls) and thorough clinical examination. Functional status will be evaluated using Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL). Nutritional status will be assessed using the Mini Nutritional Assessment (MNA), while cognitive function and mood will be evaluated using the Arabic versions of the Mini-Addenbrooke's Cognitive Examination (Mini-ACE) and the Geriatric Depression Scale (GDS), respectively.
Sarcopenia assessment will be based on muscle strength, muscle mass, and physical performance. Muscle strength will be measured using handgrip dynamometry, muscle mass will be estimated using bioelectrical impedance analysis, and physical performance will be evaluated using the Timed Up and Go Test (TUGT) and SARC-F questionnaire.
Orthostatic intolerance will be assessed through both subjective and objective measures. Participants will be evaluated for symptoms such as dizziness, syncope or presyncope, visual disturbances, fatigue, palpitations, and exercise intolerance. Symptom severity will be quantified using the Orthostatic Hypotension Questionnaire (OHQ). In addition, orthostatic vital signs will be measured using an automated monitor, with heart rate and blood pressure recorded after a 20-minute supine rest and at 1, 3, 5, and 10 minutes following standing.
Fatigue will be assessed using the Arabic version of the Fatigue Severity Scale (FSS). Physical activity levels will be evaluated using the Incidental and Planned Exercise Questionnaire (weekly version).
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: rewayda walid mahgoub, M.B.B.CH., M.Sc.
- Número de teléfono: +201144430657
- Correo electrónico: g19-29512051701747@med.asu.edu.eg
Ubicaciones de estudio
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Abbasya
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Cairo, Abbasya, Egipto
- Ain Shams University
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Contacto:
- rewayda walid mahgoub, M.B.B.CH., M.Sc
- Número de teléfono: 01144430657
- Correo electrónico: g19-29512051701747@med.asu.edu.eg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients (males or females) aged 65 or above years old.
- Participants who are willing to participate in the study.
Exclusion Criteria:
- Patients who are not willing to participate in the study.
- patients with end organ damage (CHF NYHA III/IV), end-stage renal disease, Liver cell failure, respiratory failure.
- Patients with arrhythmia or using pacemakers
- patients diagnosed with parkinsonism, Diabetes mellitus, or peripheral neuropathy.
- Active infections or inflammatory conditions (e.g., sepsis, rheumatoid flare-up)
- Patient with acute stroke, Critically ill patients, Terminal illness, Bedridden or completely immobile patients,
- Medications Influencing Fatigue/OI: High-dose opioids, sedatives, or drugs causing significant orthostatic hypotension (e.g., alpha-blockers, diuretics without stable control)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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cases
Cases: Elderly patients (≥65 years) diagnosed with sarcopenia based on the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria.
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controls
Controls: Age- and sex-matched elderly patients without sarcopenia.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Fatigue severity measured by Fatigue Severity Scale (FSS)
Periodo de tiempo: Baseline
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Difference in Fatigue Severity Scale (FSS) total score between geriatric patients with sarcopenia (defined according to European Working Group on Sarcopenia in Older People 2 criteria) and those without sarcopenia. Unit of Measure: FSS total score (range: 1-7) |
Baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Orthostatic intolerance symptoms measured by Orthostatic Hypotension Questionnaire (OHQ)
Periodo de tiempo: Baseline
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Description: Difference in Orthostatic Hypotension Questionnaire (OHQ) total score between geriatric patients with sarcopenia and those without sarcopenia. Unit of Measure: OHQ total score |
Baseline
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Orthostatic systolic blood pressure change
Periodo de tiempo: Baseline (during orthostatic assessment)
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Description: Difference in systolic blood pressure (mmHg) upon standing at 1, 3, 5, and 10 minutes between geriatric patients with sarcopenia and those without sarcopenia. Unit of Measure: mmHg |
Baseline (during orthostatic assessment)
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Orthostatic diastolic blood pressure change
Periodo de tiempo: Baseline (during orthostatic assessment)
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Description: Difference in diastolic blood pressure (mmHg) upon standing at 1, 3, 5, and 10 minutes between geriatric patients with sarcopenia and those without sarcopenia. Unit of Measure: mmHg |
Baseline (during orthostatic assessment)
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Orthostatic heart rate change
Periodo de tiempo: Baseline (during orthostatic assessment)
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Description: Difference in heart rate (beats per minute) upon standing at 1, 3, 5, and 10 minutes between geriatric patients with sarcopenia and those without sarcopenia. Unit of Measure: beats per minute |
Baseline (during orthostatic assessment)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: doha rashedy ali, professor, Ain shams university faculty of medicine.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Manifestaciones Neuromusculares
- Condiciones Patológicas, Anatómicas
- Disautonomías primarias
- Enfermedades del sistema nervioso autónomo
- Atrofia Muscular
- Atrofia
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Fatiga
- Sarcopenia
- Intolerancia ortostática
Otros números de identificación del estudio
- FMASU MD249/2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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