ARMS: The Arm Rest and Support Study

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05372328
• Collaborator: Vital Strategies (Other)
• Enrollment: 120
• Location: 1
• Arms: 6
• Anticipated Duration (Months): 9.7
• Patients Per Site Per Month: 12.3

Study Details

Study Description

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.

1. 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

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Other: Position of arm while taking blood pressure measurement	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: ARMS: The Arm Rest and Support Study
• Actual Study Start Date: Aug 9, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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)

4. 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)

Secondary Outcome Measures

1. 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

2. 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).

3. 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).

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University
• Vital Strategies

Investigators

• Principal Investigator: Tammy Brady, MD, PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT05372328
• Other Study ID Numbers: IRB00319633; 139475
• First Posted: May 12, 2022
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Johns Hopkins University: Blood pressure
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Aug 24, 2022