ARMS: The Arm Rest and Support Study

Johns Hopkins University

Status: Completed

Conditions: Hypertension

Treatments: Other: Position of arm while taking blood pressure measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT05372328

IRB00319633

139475 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 134 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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134 participants in 6 patient groups

Desk1, Lap, Side, Desk2

Other group

Description:

The order of arm positions for participants randomized to this arm will be: Desk, Lap, Side, Desk

Treatment:

Other: Position of arm while taking blood pressure measurement

Desk1, Side, Lap, Desk2

Other group

Description:

The order of arm positions for participants randomized to this arm will be: Desk, Side, Lap, Desk

Treatment:

Other: Position of arm while taking blood pressure measurement

Lap, Desk1, Side, Desk2

Other group

Description:

The order of arm positions for participants randomized to this arm will be: Lap, Desk, Side, Desk

Treatment:

Other: Position of arm while taking blood pressure measurement

Lap, Side, Desk1, Desk2

Other group

Description:

The order of arm positions for participants randomized to this arm will be: Lap, Side, Desk, Desk

Treatment:

Other: Position of arm while taking blood pressure measurement

Side, Lap, Desk1, Desk2

Other group

Description:

The order of arm positions for participants randomized to this arm will be: Side, Lap, Desk, Desk

Treatment:

Other: Position of arm while taking blood pressure measurement

Side, Desk1, Lap, Desk2

Other group

Description:

The order of arm positions for participants randomized to this arm will be: Side, Desk, Lap, Desk

Treatment:

Other: Position of arm while taking blood pressure measurement