ARMS: The Arm Rest and Support Study

Hypertension Clinical Trial

— ARMS  

Official title:

ARMS: The Arm Rest and Support Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372328
• Other study ID #: IRB00319633
• Secondary ID: 139475
• Status: Completed
• Phase: N/A
• Start date: August 9, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Vital Strategies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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