NCT07564830

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
May 2026Apr 2027

First Submitted

Initial submission to the registry

April 2, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 2, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

geriatricsarcopeniaorthostatic intolerance

Outcome Measures

Primary Outcomes (1)

  • 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)

    Baseline

Secondary Outcomes (4)

  • Orthostatic intolerance symptoms measured by Orthostatic Hypotension Questionnaire (OHQ)

    Baseline

  • Orthostatic systolic blood pressure change

    Baseline (during orthostatic assessment)

  • Orthostatic diastolic blood pressure change

    Baseline (during orthostatic assessment)

  • Orthostatic heart rate change

    Baseline (during orthostatic assessment)

Study Arms (2)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients (males or females) aged 65 or above years old.
  • Participants who are willing to participate in the study.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, Abbasya, Egypt

Location

MeSH Terms

Conditions

SarcopeniaFatigueOrthostatic Intolerance

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPrimary DysautonomiasAutonomic Nervous System Diseases

Study Officials

  • doha rashedy ali, professor

    Ain shams university faculty of medicine.

    STUDY DIRECTOR

Central Study Contacts

rewayda walid mahgoub, M.B.B.CH., M.Sc.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2026

First Posted

May 4, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations