ARMS: The Arm Rest and Support Study

Study Overview
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Brief Summary
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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
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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

Official Title
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ARMS: The Arm Rest and Support Study

Conditions
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Hypertension

Intervention / Treatment
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* Other: Position of arm while taking blood pressure measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Desk1, Lap, Side, Desk2<br>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<br>* 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.<br>|
| Other: Desk1, Side, Lap, Desk2<br>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<br>* 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.<br>|
| Other: Lap, Desk1, Side, Desk2<br>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<br>* 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.<br>|
| Other: Lap, Side, Desk1, Desk2<br>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<br>* 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.<br>|
| Other: Side, Lap, Desk1, Desk2<br>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<br>* 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.<br>|
| Other: Side, Desk1, Lap, Desk2<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure