An interventional study of Position of arm while taking blood pressure measurement in Hypertension, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Screening
Primary Objectives
1. Determine the effect of an unsupported and poorly positioned arm on initial and average triplicate blood pressure done according to clinical practice guidelines with an automated device.
a. Hypothesis: Compared to blood pressure measurements obtained with the arm supported with mid-cuff positioned at heart level, blood pressures measured with an unsupported arm and/or with mid-cuff below heart level will be significantly higher.
Secondary Objective
1. To determine if the effects differ based on the following patient characteristics:
The investigators propose a cross-sectional study of adult participants recruited from the community. Enrolled participants will have four sets of three automated blood pressure measurements, with each set taken with the arm positioned and supported as follows:
Arm supported on a desk, with mid-cuff at mid-heart level (4th intercostal space)
Arm supported on the participant's lap
Arm hanging at the participant's side, unsupported
The last period of triplicate BP measurements will always have the arm supported and mid-cuff positioned at mid-heart level
In the prior 3 periods, the arm position and support conditions are randomly ordered. Each participant will undergo a total of 12 systolic and 12 diastolic BP measurements
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 134 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The order of arm positions for participants randomized to this arm will be: Desk, Lap, Side, Desk
Other: Position of arm while taking blood pressure measurement
The order of arm positions for participants randomized to this arm will be: Desk, Side, Lap, Desk
Other: Position of arm while taking blood pressure measurement
The order of arm positions for participants randomized to this arm will be: Lap, Desk, Side, Desk
Other: Position of arm while taking blood pressure measurement
The order of arm positions for participants randomized to this arm will be: Lap, Side, Desk, Desk
Other: Position of arm while taking blood pressure measurement
The order of arm positions for participants randomized to this arm will be: Side, Lap, Desk, Desk
Other: Position of arm while taking blood pressure measurement
The order of arm positions for participants randomized to this arm will be: Side, Desk, Lap, Desk
Other: Position of arm while taking blood pressure measurement
Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which their arm position changes prior to each set of measurements.
Difference in systolic blood pressure in lap1 vs desk arm position
Absolute difference between (1) 1st systolic BP and (2) average of 3 systolic BP from measurements (mmHg) obtained in: Lap vs Desk1
Time frame: Time of measurement up to 90 minutes
Difference in diastolic blood pressure in side vs desk 1 arm position
Absolute difference between (1) 1st diastolic BP and (2) average of 3 diastolic BP from measurements (mmHg) obtained with: Side vs Desk1
Time frame: Time of measurement up to 90 minutes
Difference of systolic and diastolic differences
Systolic and Diastolic BP difference of differences between: (Desk1-Desk2) and (Lap-Desk1) from measurements (mmHg)
Time frame: Time of measurement up to 90 minutes
Difference of diastolic differences
Systolic and Diastolic Difference of differences in BP measurements (mmHg) between: (Desk1-Desk2) and (Side-Desk1)
Time frame: Time of measurement up to 90 minutes
Difference in blood pressure based on hypertension status
To determine the blood pressure difference based on hypertensive (≥140/90) vs. non-hypertensive participants
Time frame: Time of measurement up to 90 minutes
Difference in blood pressure based on age
To determine the blood pressure difference based on age (≥ 60 years vs. \<60 years).
Time frame: Time of measurement up to 90 minutes
Difference in blood pressure based on regular healthcare visits
To determine the blood pressure difference between participants receiving regular health care visits (\>1 year vs. ≤ 1 year).
Time frame: Time of measurement up to 90 minutes
Difference in blood pressure based on arm length to cuff width ratio
To determine the blood pressure difference of arm length to cuff width ratio
Time frame: Time of measurement up to 90 minutes
Ran from Aug 2022 to primary completion in Jun 2023, 9 months.
Of 1,339 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's 9 months is below that.
Counting every sponsor, half of 1,433 studies reached it within 23 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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