NCT05372328

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 9, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

May 9, 2022

Last Update Submit

September 8, 2023

Conditions

Hypertension

Keywords

Blood pressure

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (4)

  • Difference in blood pressure based on hypertension status

    Time of measurement up to 90 minutes

  • Difference in blood pressure based on age

    Time of measurement up to 90 minutes

  • Difference in blood pressure based on regular healthcare visits

    Time of measurement up to 90 minutes

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

    Time of measurement up to 90 minutes

Study Arms (6)

Desk1, Lap, Side, Desk2

OTHER

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

Desk1, Side, Lap, Desk2

OTHER

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

Lap, Desk1, Side, Desk2

OTHER

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

Lap, Side, Desk1, Desk2

OTHER

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

Side, Lap, Desk1, Desk2

OTHER

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

Side, Desk1, Lap, Desk2

OTHER

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

Interventions

Position of arm while taking blood pressure measurementOTHER

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.

Desk1, Lap, Side, Desk2Desk1, Side, Lap, Desk2Lap, Desk1, Side, Desk2Lap, Side, Desk1, Desk2Side, Desk1, Lap, Desk2Side, Lap, Desk1, Desk2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • 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.

    PMID: 39373998DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Tammy Brady, MD, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 12, 2022

Study Start

August 9, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

September 11, 2023

Record last verified: 2023-09

Locations

US(1)