Clinical trial NCT05372328: ARMS: The Arm Rest and Support Study
Official title: ARMS: The Arm Rest and Support Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Blood pressure
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Vital Strategies
First posted: 2022-05-12
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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

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

Primary outcomes:
measure: Difference in systolic blood pressure in lap1 vs desk arm position
timeFrame: Time of measurement up to 90 minutes
measure: Difference in diastolic blood pressure in side vs desk 1 arm position
timeFrame: Time of measurement up to 90 minutes
measure: Difference of systolic and diastolic differences
timeFrame: Time of measurement up to 90 minutes
measure: Difference of diastolic differences
timeFrame: Time of measurement up to 90 minutes
Secondary outcomes:
measure: Difference in blood pressure based on hypertension status
timeFrame: Time of measurement up to 90 minutes
measure: Difference in blood pressure based on age
timeFrame: Time of measurement up to 90 minutes
measure: Difference in blood pressure based on regular healthcare visits
timeFrame: Time of measurement up to 90 minutes
measure: Difference in blood pressure based on arm length to cuff width ratio
timeFrame: Time of measurement up to 90 minutes
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Tammy Brady, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: