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

2026年4月27日 更新者: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.

研究概览

地位

尚未招聘

详细说明

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).

研究类型

观察性的

注册 (估计的)

90

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

是的

取样方法

概率样本

研究人群

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

描述

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)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Fatigue severity measured by Fatigue Severity Scale (FSS)
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Orthostatic intolerance symptoms measured by Orthostatic Hypotension Questionnaire (OHQ)
大体时间: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
大体时间: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
大体时间: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
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:doha rashedy ali, professor、Ain shams university faculty of medicine.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月1日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年4月1日

研究注册日期

首次提交

2026年4月2日

首先提交符合 QC 标准的

2026年4月27日

首次发布 (实际的)

2026年5月4日

研究记录更新

最后更新发布 (实际的)

2026年5月4日

上次提交的符合 QC 标准的更新

2026年4月27日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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