Sarcopenia and Orthostatic Hypotension
The Relationship Between Sarcopenia and Orthostatic Hypotension
1 other identifier
observational
100
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2018
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
September 6, 2018
CompletedStudy Start
First participant enrolled
September 10, 2018
CompletedFirst Posted
Study publicly available on registry
November 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 7, 2018
November 1, 2018
3 months
September 6, 2018
November 4, 2018
Conditions
Keywords
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.
Elderly without sarcopenia
50 patients aged 75 or older without sarcopenia Intervention: Each patient's supine and standing blood pressures will be measured.
Interventions
Intervention: Each patient's supine and standing blood pressure measurements will be recorded
Eligibility Criteria
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)
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kadriye Orta Kılıçkesmez, Prof
Şişli Hamidiye Etfal Education and Research Hospital
Central Study Contacts
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