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Association Between Sarcopenia, Fatigue and Orthostatic Intolerance in Geriatric Patients: A Case Control Study

27 de abril de 2026 actualizado por: Ain Shams University

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

Aún no reclutando

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

De observación

Inscripción (Estimado)

90

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Abbasya
      • Cairo, Abbasya, Egipto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra de probabilidad

Población de estudio

elderly patients both males and females who are interviewed at AIN SHAMS UNIVERSITY HOSPITALS or at the hospital clinic.

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
cases
Cases: Elderly patients (≥65 years) diagnosed with sarcopenia based on the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria.
controls
Controls: Age- and sex-matched elderly patients without sarcopenia.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Fatigue severity measured by Fatigue Severity Scale (FSS)
Periodo de tiempo: Baseline

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Orthostatic intolerance symptoms measured by Orthostatic Hypotension Questionnaire (OHQ)
Periodo de tiempo: Baseline

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
Orthostatic systolic blood pressure change
Periodo de tiempo: Baseline (during orthostatic assessment)

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)
Orthostatic diastolic blood pressure change
Periodo de tiempo: Baseline (during orthostatic assessment)

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)
Orthostatic heart rate change
Periodo de tiempo: Baseline (during orthostatic assessment)

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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: doha rashedy ali, professor, Ain shams university faculty of medicine.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de mayo de 2026

Finalización primaria (Estimado)

1 de enero de 2027

Finalización del estudio (Estimado)

1 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

2 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de abril de 2026

Publicado por primera vez (Actual)

4 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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