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ARMS: The Arm Rest and Support Study

NCT05372328 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2023-09-11

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Tammy Brady, MD, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-09
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05372328 on ClinicalTrials.gov