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| ID | Type | Description | Link |
|---|---|---|---|
| 139475 | Other Grant/Funding Number | Vital Strategies |
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| Name | Class |
|---|---|
| Vital Strategies | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desk1, Lap, Side, Desk2 | Other | The order of arm positions for participants randomized to this arm will be: Desk, Lap, Side, Desk |
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| Desk1, Side, Lap, Desk2 | Other | The order of arm positions for participants randomized to this arm will be: Desk, Side, Lap, Desk |
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| Lap, Desk1, Side, Desk2 | Other | The order of arm positions for participants randomized to this arm will be: Lap, Desk, Side, Desk |
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| Lap, Side, Desk1, Desk2 | Other | The order of arm positions for participants randomized to this arm will be: Lap, Side, Desk, Desk |
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| Side, Lap, Desk1, Desk2 | Other | The order of arm positions for participants randomized to this arm will be: Side, Lap, Desk, Desk |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Position of arm while taking blood pressure measurement | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 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 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 of measurement up to 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in blood pressure based on hypertension status | To determine the blood pressure difference based on hypertensive (≥140/90) vs. non-hypertensive participants | Time of measurement up to 90 minutes |
| Difference in blood pressure based on age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tammy Brady, MD, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39373998 | Derived | Liu H, Zhao D, Sabit A, Pathiravasan CH, Ishigami J, Charleston J, Miller ER 3rd, Matsushita K, Appel LJ, Brady TM. Arm Position and Blood Pressure Readings: The ARMS Crossover Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1436-1442. doi: 10.1001/jamainternmed.2024.5213. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Side, Desk1, Lap, Desk2 | Other | The order of arm positions for participants randomized to this arm will be: Side, Desk, Lap, Desk |
|
To determine the blood pressure difference based on age (≥ 60 years vs. <60 years).
| 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 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 of measurement up to 90 minutes |