- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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).
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: rewayda walid mahgoub, M.B.B.CH., M.Sc.
- 전화번호: +201144430657
- 이메일: g19-29512051701747@med.asu.edu.eg
연구 장소
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Abbasya
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Cairo, Abbasya, 이집트
- Ain Shams University
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연락하다:
- rewayda walid mahgoub, M.B.B.CH., M.Sc
- 전화번호: 01144430657
- 이메일: g19-29512051701747@med.asu.edu.eg
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참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Fatigue severity measured by Fatigue Severity Scale (FSS)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Orthostatic intolerance symptoms measured by Orthostatic Hypotension Questionnaire (OHQ)
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 책임자: doha rashedy ali, professor, Ain shams university faculty of medicine.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .