ARMS: The Arm Rest and Support Study (ARMS)

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Position of arm while taking blood pressure measurement

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

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Desk1, Lap, Side, Desk2; 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; 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.
Other: Desk1, Side, Lap, Desk2; 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; 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.
Other: Lap, Desk1, Side, Desk2; 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; 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.
Other: Lap, Side, Desk1, Desk2; 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; 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.
Other: Side, Lap, Desk1, Desk2; 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; 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.
Other: Side, Desk1, Lap, Desk2; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in blood pressure based on hypertension status	To determine the blood pressure difference based on hypertensive (≥140/90) vs. non-hypertensive participants	Time of measurement up to 90 minutes
Difference in blood pressure based on age	To determine the blood pressure difference based on age (≥ 60 years vs. <60 years).	Time of measurement up to 90 minutes
Difference in blood pressure based on regular healthcare visits	To determine the blood pressure difference between participants receiving regular health care visits (>1 year vs. ≤ 1 year).	Time of measurement up to 90 minutes
Difference in blood pressure based on arm length to cuff width ratio	To determine the blood pressure difference of arm length to cuff width ratio	Time of measurement up to 90 minutes

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Vital Strategies
• Investigators: Principal Investigator: Tammy Brady, MD, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: IRB00319633; 139475 (Other Grant/Funding Number: Vital Strategies)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No