NCT05372328

ARMS: The Arm Rest and Support Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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: * Hypertensive blood pressure (SBP≥130 mmHg vs. \<130 mmHg). * Age (≥ 60 years vs. \< 60 years) Greater vascular stiffness \> lesser vascular stiffness * Regular health care (Last BP measured \>1 year ago vs. ≤1 year ago) * Arm length:cuff width

Detailed description

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) * Desk1 * Reference measurement * Arm supported on the participant's lap * Lap * Arm hanging at the participant's side, unsupported * Side * The last period of triplicate BP measurements will always have the arm supported and mid-cuff positioned at mid-heart level * Desk2 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

Conditions

• Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-09
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2022-05-12
• Last updated: 2023-09-11

Locations

1 site across 1 country: United States