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Completed

NCT Number: NCT05372328

ARMS: The Arm Rest and Support Study

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years

Exclusion criteria

  • Presence of the following on both arms: rashes, gauze dressings, casts, edema, paralysis, tubes, open sores or wounds, A-V shunts.
  • Being mentally impaired
  • Being pregnant
  • Arm circumference exceeding 55 cm.
  • >80 years of age

Treatment and study plan

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.

Primary outcomes

  1. Difference in systolic blood pressure in lap1 vs desk arm position

    Time frame: Time of measurement up to 90 minutes

    Absolute difference between (1) 1st systolic BP and (2) average of 3 systolic BP from measurements (mmHg) obtained in: Lap vs Desk1

  2. Difference in diastolic blood pressure in side vs desk 1 arm position

    Time frame: Time of measurement up to 90 minutes

    Absolute difference between (1) 1st diastolic BP and (2) average of 3 diastolic BP from measurements (mmHg) obtained with: Side vs Desk1

  3. Difference of systolic and diastolic differences

    Time frame: Time of measurement up to 90 minutes

    Systolic and Diastolic BP difference of differences between: (Desk1-Desk2) and (Lap-Desk1) from measurements (mmHg)

  4. Difference of diastolic differences

    Time frame: Time of measurement up to 90 minutes

    Systolic and Diastolic Difference of differences in BP measurements (mmHg) between: (Desk1-Desk2) and (Side-Desk1)

Secondary outcomes

  1. Difference in blood pressure based on hypertension status

    Time frame: Time of measurement up to 90 minutes

    To determine the blood pressure difference based on hypertensive (≥140/90) vs. non-hypertensive participants

  2. Difference in blood pressure based on age

    Time frame: Time of measurement up to 90 minutes

    To determine the blood pressure difference based on age (≥ 60 years vs. <60 years).

  3. Difference in blood pressure based on regular healthcare visits

    Time frame: Time of measurement up to 90 minutes

    To determine the blood pressure difference between participants receiving regular health care visits (>1 year vs. ≤ 1 year).

  4. Difference in blood pressure based on arm length to cuff width ratio

    Time frame: Time of measurement up to 90 minutes

    To determine the blood pressure difference of arm length to cuff width ratio

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Vital Strategies

Registry information

Acronym: ARMS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 12, 2022
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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