Best Rest: Rest Time Before Blood Pressure Measurement Trial

NCT04031768 | Completed

• 1 other identifier: IRB00214827
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to:

1. 1.Determine the impact of wait time before initiating BP measurement on BP variability
2. 2.Determine the difference in BP variability between measurements by amount of initial rest.

Conditions

Hypertension; Blood Pressure; Cardiovascular Diseases; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (2)

• Difference in Systolic Blood Pressure (mmHg)

  Comparison of the average of 3 systolic BP measurements (mmHg) measured after 5 minutes rest with the average of 3 systolic blood pressure (SBP) measured after the other periods of rest (0 minutes, 2 minutes, second 5 minutes of rest)

  90 minutes

• Difference in Diastolic Blood Pressure (mmHg)

  Comparison of the average of 3 diastolic BP measurements (mmHg) measured after 5 minutes rest with the average of 3 diastolic blood pressure (DBP) measured after the other periods of rest (0 minutes, 2 minutes, second 5 minutes of rest)

  90 minutes

Secondary Outcomes (3)

• Blood Pressure Variability (mmHg)

  90 minutes

• Standard Deviation of Blood Pressures (mmHg)

  90 minutes

• Coefficient of Variation of Blood Pressures

  90 minutes

Other Outcomes (1)

• Total time required to obtain a BP measurement (seconds)

  90 minutes

Study Arms (6)

0-2-5-5 minutes rest group

OTHER

The order of rest periods for participants randomized to this arm will be: 0 minutes 2 minutes 5 minutes 5 minutes

Other: Timing of rest prior to blood pressure measurement

0-5-2-5 minutes rest group

OTHER

The order of rest periods for participants randomized to this arm will be: 0 minutes 5 minutes 2 minutes 5 minutes

Other: Timing of rest prior to blood pressure measurement

2-0-5-5 minutes rest group

OTHER

The order of rest periods for participants randomized to this arm will be: 2 minutes 0 minutes 5 minutes 5 minutes

Other: Timing of rest prior to blood pressure measurement

5-0-2-5 minutes rest group

OTHER

The order of rest periods for participants randomized to this arm will be: 5 minutes 0 minutes 2 minutes 5 minutes

Other: Timing of rest prior to blood pressure measurement

2-5-0-5 minutes rest group

OTHER

The order of rest periods for participants randomized to this arm will be: 2 minutes 5 minutes 0 minutes 5 minutes

Other: Timing of rest prior to blood pressure measurement

5-2-0-5 minutes rest group

OTHER

The order of rest periods for participants randomized to this arm will be: 5 minutes 2 minutes 0 minutes 5 minutes

Other: Timing of rest prior to blood pressure measurement

Interventions

Timing of rest prior to blood pressure measurement OTHER

Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which they rest prior to each set of measurements.

0-2-5-5 minutes rest group; 0-5-2-5 minutes rest group; 2-0-5-5 minutes rest group; 2-5-0-5 minutes rest group; 5-0-2-5 minutes rest group; 5-2-0-5 minutes rest group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years

You may not qualify if:

• Presence of the following on both arms: rashes, gauze dressings, casts, edema, paralysis, tubes, open sores or wounds, withered arms, A-V shunts, or if blood has been drawn from arm within last week.
• Being mentally impaired, pregnant.
• Arm circumference exceeding 50 cm.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Vital Strategies: collaborator

Study Sites (1)

Johns Hopkins School of Medicine Division of Pediatric Nephrology

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Brady TM, Charleston J, Ishigami J, Miller ER 3rd, Matsushita K, Appel LJ. Effects of Different Rest Period Durations Prior to Blood Pressure Measurement: The Best Rest Trial. Hypertension. 2021 Nov;78(5):1511-1519. doi: 10.1161/HYPERTENSIONAHA.121.17496. Epub 2021 Oct 4.

  PMID: 34601959 RESULT

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Tammy Brady, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 24, 2019
• Study Start: November 11, 2019
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: September 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)