HypertensionARMSNCT05372328
ARMS: The Arm Rest and Support Study
A study testing Position of arm while taking blood pressure measurement in people with Hypertension, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Position of arm while taking blood pressure measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Primary Objectives
- 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.
- 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.
Read more
Secondary Objective
- 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
Read the 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
- Conditions
- Hypertension
- Being tested
- Position of arm while taking blood pressure measurement
- Keywords
- Blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position of arm while taking blood pressure measurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Desk1, Lap, Side, Desk2 | Other | The order of arm positions for participants randomized to this arm will be:
Desk, Lap, Side, Desk Receives: Other: Position of arm while taking blood pressure measurement |
| Desk1, Side, Lap, Desk2 | Other | The order of arm positions for participants randomized to this arm will be:
Desk, Side, Lap, Desk Receives: Other: Position of arm while taking blood pressure measurement |
| Lap, Desk1, Side, Desk2 | Other | The order of arm positions for participants randomized to this arm will be:
Lap, Desk, Side, Desk Receives: Other: Position of arm while taking blood pressure measurement |
| Lap, Side, Desk1, Desk2 | Other | The order of arm positions for participants randomized to this arm will be:
Lap, Side, Desk, Desk Receives: Other: Position of arm while taking blood pressure measurement |
| Side, Lap, Desk1, Desk2 | Other | The order of arm positions for participants randomized to this arm will be:
Side, Lap, Desk, Desk Receives: Other: Position of arm while taking blood pressure measurement |
| Side, Desk1, Lap, Desk2 | Other | The order of arm positions for participants randomized to this arm will be:
Side, Desk, Lap, Desk Receives: Other: Position of arm while taking blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Time of measurement up to 90 minutes
Secondary outcomes (4)
Difference in blood pressure based on hypertension status
To determine the blood pressure difference based on hypertensive (≥140/90) vs. non-hypertensive participants
Measured: 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).
Measured: 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).
Measured: 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
Measured: Time of measurement up to 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start9 Aug 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Vital Strategies
- Responsible party
- Sponsor
- Investigators
- Tammy Brady, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372328
- Sponsor's protocol ID
- IRB00319633
- Other IDs
- 139475
- Acronym
- ARMS
- Status last verified
- Sep 2023
- First submitted
- 9 May 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu H, Zhao D, Sabit A, Pathiravasan CH, Ishigami J, Charleston J, Miller ER 3rd, Matsushita K, Appel LJ, Brady TM. Arm Position and Blood Pressure Readings: The ARMS Crossover Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1436-1442. doi: 10.1001/jamainternmed.2024.5213.
PubMed 39373998
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARMS: The Arm Rest and Support Study
- ClinicalTrials.gov ID
- NCT05372328
- Acronym / sponsor ID
- ARMS / IRB00319633
- Conditions
- Hypertension
- Keywords
- Blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Vital Strategies
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives
- 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.
- 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
- 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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Desk1, Lap, Side, Desk2 | Other | Other: Position of arm while taking blood pressure measurementThe order of arm positions for participants randomized to this arm will be: Desk, Lap, Side, Desk |
| Desk1, Side, Lap, Desk2 | Other | Other: Position of arm while taking blood pressure measurementThe order of arm positions for participants randomized to this arm will be: Desk, Side, Lap, Desk |
| Lap, Desk1, Side, Desk2 | Other | Other: Position of arm while taking blood pressure measurementThe order of arm positions for participants randomized to this arm will be: Lap, Desk, Side, Desk |
| Lap, Side, Desk1, Desk2 | Other | Other: Position of arm while taking blood pressure measurementThe order of arm positions for participants randomized to this arm will be: Lap, Side, Desk, Desk |
| Side, Lap, Desk1, Desk2 | Other | Other: Position of arm while taking blood pressure measurementThe order of arm positions for participants randomized to this arm will be: Side, Lap, Desk, Desk |
| Side, Desk1, Lap, Desk2 | Other | Other: Position of arm while taking blood pressure measurementThe order of arm positions for participants randomized to this arm will be: Side, Desk, Lap, Desk |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 18 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Position of arm while taking blood pressure measurementEach 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, Lap, Side, Desk2, Desk1, Side, Lap, Desk2, Lap, Desk1, Side, Desk2, Lap, Side, Desk1, Desk2, Side, Desk1, Lap, Desk2, Side, Lap, Desk1, Desk2 |
Primary outcome
Difference in systolic blood pressure in lap1 vs desk arm position
Time frame: 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
Difference in diastolic blood pressure in side vs desk 1 arm position
Time frame: 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
Difference of systolic and diastolic differences
Time frame: Time of measurement up to 90 minutes
Systolic and Diastolic BP difference of differences between: (Desk1-Desk2) and (Lap-Desk1) from measurements (mmHg)
Difference of diastolic differences
Time frame: Time of measurement up to 90 minutes
Systolic and Diastolic Difference of differences in BP measurements (mmHg) between: (Desk1-Desk2) and (Side-Desk1)
4 secondary outcomes
Difference in blood pressure based on hypertension status
Time frame: Time of measurement up to 90 minutes
Difference in blood pressure based on age
Time frame: Time of measurement up to 90 minutes
Difference in blood pressure based on regular healthcare visits
Time frame: Time of measurement up to 90 minutes
Difference in blood pressure based on arm length to cuff width ratio
Time frame: Time of measurement up to 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Derived from this study: PubMed 39373998Liu H, Zhao D, Sabit A, Pathiravasan CH, Ishigami J, Charleston J, Miller ER 3rd, Matsushita K, Appel LJ, Brady TM. Arm Position and Blood Pressure Readings: The ARMS Crossover Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1436-1442. doi: 10.1001/jamainternmed.2024.5213.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tammy Brady, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Position of arm while taking blood pressure measurement in people with Hypertension, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in systolic blood pressure in lap1 vs desk arm position (time frame: Time of measurement up to 90 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05372328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.