ARMS: The Arm Rest and Support Study

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: Position of arm while taking blood pressure measurement

• Registration Number: NCT05372328
• Lead Sponsor: Johns Hopkins University

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

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-12
• Study Start: 2022-08-09
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Desk1, Side, Lap, Desk2	Position of arm while taking blood pressure measurement	The order of arm positions for participants randomized to this arm will be: Desk, Side, Lap, Desk
Side, Desk1, Lap, Desk2	Position of arm while taking blood pressure measurement	The order of arm positions for participants randomized to this arm will be: Side, Desk, Lap, Desk
Desk1, Lap, Side, Desk2	Position of arm while taking blood pressure measurement	The order of arm positions for participants randomized to this arm will be: Desk, Lap, Side, Desk
Lap, Desk1, Side, Desk2	Position of arm while taking blood pressure measurement	The order of arm positions for participants randomized to this arm will be: Lap, Desk, Side, Desk
Lap, Side, Desk1, Desk2	Position of arm while taking blood pressure measurement	The order of arm positions for participants randomized to this arm will be: Lap, Side, Desk, Desk
Side, Lap, Desk1, Desk2	Position of arm while taking blood pressure measurement	The order of arm positions for participants randomized to this arm will be: Side, Lap, Desk, Desk

Primary Outcome Measures

Name	Time	Method
Difference of systolic and diastolic differences	Time of measurement up to 90 minutes	Systolic and Diastolic BP difference of differences between: (Desk1-Desk2) and (Lap-Desk1) from measurements (mmHg)
Difference of diastolic differences	Time of measurement up to 90 minutes	Systolic and Diastolic Difference of differences in BP measurements (mmHg) between: (Desk1-Desk2) and (Side-Desk1)
Difference in systolic blood pressure in lap1 vs desk arm position	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
Difference in diastolic blood pressure in side vs desk 1 arm position	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

Secondary Outcome Measures

Name	Time	Method
Difference in blood pressure based on age	Time of measurement up to 90 minutes	To determine the blood pressure difference based on age (≥ 60 years vs. \<60 years).
Difference in blood pressure based on regular healthcare visits	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).
Difference in blood pressure based on arm length to cuff width ratio	Time of measurement up to 90 minutes	To determine the blood pressure difference of arm length to cuff width ratio
Difference in blood pressure based on hypertension status	Time of measurement up to 90 minutes	To determine the blood pressure difference based on hypertensive (≥140/90) vs. non-hypertensive participants

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States