SarcopeniaNCT07564830
Association Between Sarcopenia, Fatigue and Orthostatic Intolerance in Geriatric Patients: A Case Control Study
An observational study of Sarcopenia and Fatigue, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Fatigue, Orthostatic Intolerance
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- May 2026to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: elderly patients both males and females who are interviewed at AIN SHAMS UNIVERSITY HOSPITALS or at the hospital clinic.
Who may be able to join
- Patients (males or females) aged 65 or above years old.
- Participants who are willing to participate in the study.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain shams university
Cairo, Abbasya
rewayda walid mahgoub, M.B.B.CH., M.Sc, 01144430657, g19-29512051701747@med.asu.edu.eg
About this 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.
Read the 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).
- Conditions
- Sarcopenia, Fatigue, Orthostatic Intolerance
- Keywords
- geriatric, sarcopenia, orthostatic intolerance
- Medical subject headings
- Sarcopenia, Fatigue, Orthostatic Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Fatigue severity measured by Fatigue Severity Scale (FSS)
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)
Measured: Baseline
Secondary outcomes (4)
Orthostatic intolerance symptoms measured by Orthostatic Hypotension Questionnaire (OHQ)
Description:
Difference in Orthostatic Hypotension Questionnaire (OHQ) total score between geriatric patients with sarcopenia and those without sarcopenia.
Unit of Measure:
OHQ total score
Measured: Baseline
Orthostatic systolic blood pressure change
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
Measured: Baseline (during orthostatic assessment)
Orthostatic diastolic blood pressure change
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
Measured: Baseline (during orthostatic assessment)
Orthostatic heart rate change
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
Measured: Baseline (during orthostatic assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study startMay 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- doha rashedy ali, professor, Study director, Ain shams university faculty of medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564830
- Sponsor's protocol ID
- FMASU MD249/2025
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Sarcopenia, Fatigue and Orthostatic Intolerance in Geriatric Patients: A Case Control Study
- ClinicalTrials.gov ID
- NCT07564830
- Acronym / sponsor ID
- FMASU MD249/2025
- Conditions
- Sarcopenia, Fatigue, Orthostatic Intolerance
- Keywords
- geriatric, sarcopenia, orthostatic intolerance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- elderly patients both males and females who are interviewed at AIN SHAMS UNIVERSITY HOSPITALS or at the hospital clinic.
Key inclusion criteria (2 listed)
- Patients (males or females) aged 65 or above years old.
- Participants who are willing to participate in the study.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
4 secondary outcomes
Orthostatic intolerance symptoms measured by Orthostatic Hypotension Questionnaire (OHQ)
Time frame: Baseline
Orthostatic systolic blood pressure change
Time frame: Baseline (during orthostatic assessment)
Orthostatic diastolic blood pressure change
Time frame: Baseline (during orthostatic assessment)
Orthostatic heart rate change
Time frame: Baseline (during orthostatic assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
doha rashedy ali, professor study director
Ain shams university faculty of medicine.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Fatigue, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact rewayda walid mahgoub, M.B.B.CH., M.Sc. (+201144430657, g19-29512051701747@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue severity measured by Fatigue Severity Scale (FSS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.