ARMS: The Arm Rest and Support Study

NCT ID: NCT05372328

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-09
• Study Completion Date: 2023-06-01

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Desk1, Lap, Side, Desk2

The order of arm positions for participants randomized to this arm will be:

Desk, Lap, Side, Desk

Group Type: OTHER

Position of arm while taking blood pressure measurement

Intervention Type: 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.

Desk1, Side, Lap, Desk2

The order of arm positions for participants randomized to this arm will be:

Desk, Side, Lap, Desk

Group Type: OTHER

Position of arm while taking blood pressure measurement

Intervention Type: 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.

Lap, Desk1, Side, Desk2

The order of arm positions for participants randomized to this arm will be:

Lap, Desk, Side, Desk

Group Type: OTHER

Position of arm while taking blood pressure measurement

Intervention Type: 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.

Lap, Side, Desk1, Desk2

The order of arm positions for participants randomized to this arm will be:

Lap, Side, Desk, Desk

Group Type: OTHER

Position of arm while taking blood pressure measurement

Intervention Type: 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.

Side, Lap, Desk1, Desk2

The order of arm positions for participants randomized to this arm will be:

Side, Lap, Desk, Desk

Group Type: OTHER

Position of arm while taking blood pressure measurement

Intervention Type: 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.

Side, Desk1, Lap, Desk2

The order of arm positions for participants randomized to this arm will be:

Side, Desk, Lap, Desk

Group Type: OTHER

Position of arm while taking blood pressure measurement

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vital Strategies

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tammy Brady, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39373998 (View on PubMed)

Other Identifiers

139475

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00319633

Identifier Type: -

Identifier Source: org_study_id