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

April 27, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Detailed Description

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).

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue severity measured by Fatigue Severity Scale (FSS)
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orthostatic intolerance symptoms measured by Orthostatic Hypotension Questionnaire (OHQ)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 27, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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