NCT03732716

Brief Summary

Elderly patients generally have a tendency for having sarcopenia which refers to muscle loss that may be related to many factors. These patients also have a tendency to falls and injuries. Whether elderly sarcopenic patients have abrupt blood pressure drops upon standing remains unknown. Therefore, in this study, we sought to determine the incidence of orthostatic hypotension in sarcopenic elderly patients and compare it with elderly patients with no sarcopenia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

September 10, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

September 6, 2018

Last Update Submit

November 4, 2018

Conditions

Keywords

blood pressureelderlysarcopeniafall

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure

    All blood pressure measurements will be performed in the morning after an eight-hour fasting. After 5-minute rest, the first blood pressure measurement will be taken when the patients are supine. Later, three more consecutive measurements will be recorded when the patients stand up each being one-minute apart. All measurements will be performed using a fully automated sphygmomanometer that is attached with the correctly sized cuff matching to the patients' upper arm circumference. OH is defined as a decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure of 10 mm Hg within 3 minutes of standing. The accompanying symptoms such as dizziness, unable to maintain balance, blurred vision will also be recorded.

    0-3 minutes

Study Arms (2)

Elderly with sarcopenia

50 patients aged 75 or older with sarcopenia Intervention: Each patient's supine and standing blood pressures will be measured.

Diagnostic Test: blood pressure measurement

Elderly without sarcopenia

50 patients aged 75 or older without sarcopenia Intervention: Each patient's supine and standing blood pressures will be measured.

Diagnostic Test: blood pressure measurement

Interventions

Intervention: Each patient's supine and standing blood pressure measurements will be recorded

Elderly with sarcopeniaElderly without sarcopenia

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly patients ( 75 or older) with and without sarcopenia

You may qualify if:

  • Patients 75 years or older

You may not qualify if:

  • Pace-maker
  • End stage renal insufficiency
  • End stage malignancy
  • Dehydration
  • Severe anemia ( Hgb \< 8 gr/dl)
  • Acute infection
  • Marked edema
  • Neurodegenerative disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şişli Hamidiye Etfal Education and Research Hospital

Istanbul, 34200, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Hashimoto Y, Kaji A, Sakai R, Hamaguchi M, Okada H, Ushigome E, Asano M, Yamazaki M, Fukui M. Sarcopenia is associated with blood pressure variability in older patients with type 2 diabetes: A cross-sectional study of the KAMOGAWA-DM cohort study. Geriatr Gerontol Int. 2018 Sep;18(9):1345-1349. doi: 10.1111/ggi.13487. Epub 2018 Jul 24.

    PMID: 30039599BACKGROUND

MeSH Terms

Conditions

Hypotension, OrthostaticSarcopenia

Interventions

Blood Pressure Determination

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisPhysical Examination

Study Officials

  • Kadriye Orta Kılıçkesmez, Prof

    Şişli Hamidiye Etfal Education and Research Hospital

    STUDY DIRECTOR

Central Study Contacts

Kudret Keskin, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 6, 2018

First Posted

November 7, 2018

Study Start

September 10, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 7, 2018

Record last verified: 2018-11

Locations