- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: rewayda walid mahgoub, M.B.B.CH., M.Sc.
- Número de telefone: +201144430657
- E-mail: g19-29512051701747@med.asu.edu.eg
Locais de estudo
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Abbasya
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Cairo, Abbasya, Egito
- Ain Shams University
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Contato:
- rewayda walid mahgoub, M.B.B.CH., M.Sc
- Número de telefone: 01144430657
- E-mail: g19-29512051701747@med.asu.edu.eg
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Fatigue severity measured by Fatigue Severity Scale (FSS)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Orthostatic intolerance symptoms measured by Orthostatic Hypotension Questionnaire (OHQ)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
- Diretor de estudo: doha rashedy ali, professor, Ain shams university faculty of medicine.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Manifestações Neuromusculares
- Condições Patológicas, Anatômicas
- Disautonomias primárias
- Doenças do Sistema Nervoso Autônomo
- Atrofia Muscular
- Atrofia
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Fadiga
- Sarcopenia
- Intolerância Ortostática
Outros números de identificação do estudo
- FMASU MD249/2025
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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