Blood Pressure MeasurementPOSE-SBPNCT07878858
Equivalence of Systolic Blood Pressure Measurements Between Fowler and Seated Positions
A study testing blood pressure measurement in the semi-recumbent position and Standard BP measurement in people with Blood Pressure Measurement, run by Iuliu Hatieganu University of Medicine and Pharmacy at 2 sites in Romania.
Trial summary
Blood pressure is an important part of checking heart health. Blood pressure is usually measured while sitting, but in everyday medical care it is sometimes measured in other positions, such as the Fowler position, where the upper body is raised. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure Measurement
- What is being tested?
- blood pressure measurement in the semi-recumbent position and Standard BP measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesRomania
- Study dates
- 20 Oct 2026to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years
- Arm circumference 22-42 cm
- Ability to provide informed consent
Who cannot join
- Inability to maintain required positions
- Pregnancy
- Any condition interfering with accurate BP measurement (i.e., atrial fibrillation)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Romania2 sites
Centrul Medical Transilvania
Cluj-Napoca, Cluj, 40034
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, Cluj, 40034
About this study
Official title: Equivalence of Systolic Blood Pressure Measurements Between Fowler and Seated Positions: A Randomized Paired Equivalence Trial
Blood pressure is an important part of checking heart health. Blood pressure is usually measured while sitting, but in everyday medical care it is sometimes measured in other positions, such as the Fowler position, where the upper body is raised. This study will compare blood pressure measured while sitting with blood pressure measured in the Fowler position to see whether the results are similar enough to be considered equivalent. Adults aged 18 or older who can give informed consent and have an arm circumference of 22-42 cm may take part. Each participant will have their blood pressure measured in both positions, with the order chosen randomly. People who cannot maintain the required positions or whose condition could affect the accuracy of the blood pressure measurement will not take part.
Read the detailed description
Background and Rationale Blood pressure (BP) measurement is a cornerstone of cardiovascular assessment. Standard guidelines recommend seated BP measurements; however, in routine clinical practice, measurements are frequently obtained in alternative positions such as the Fowler position. This study aims to determine whether SBP measurements obtained in the Fowler position are clinically equivalent to those obtained in the seated position.
Objectives The primary objective is to determine whether SBP measured in the Fowler position is equivalent to SBP measured in the seated position within a predefined clinical equivalence margin of ±5 mmHg.
Hypothesis Null hypothesis: The mean paired difference in SBP between Fowler and seated positions is outside the equivalence margin of ±5 mmHg.
Alternative hypothesis: The mean paired difference in SBP between Fowler and seated positions lies within the equivalence margin of ±5 mmHg.
Study Design This is a prospective, randomized, paired equivalence trial. Each participant will undergo SBP measurement in both seated and Fowler positions, with the order of positions randomized.
Setting Outpatient cardiology clinic. Blood Pressure Measurement Protocol Blood pressure will be measured using a validated automated OMRON device. For each position, three consecutive (1 minute apart) SBP measurements will be obtained and averaged. A rest period of 5 minutes will be observed after changing position before measurements, with a 5-minute rest period before the first BP measurement. The same arm and appropriately sized cuff will be used for all measurements.
Seated position
- Back supported
- Feet flat on the floor
- Legs uncrossed
- Arm supported at mid-sternal (right atrial) level Fowler position
- Semi-recumbent position with trunk elevated at 30° measured using an inclinometer
- Knees extended
- Back supported
Randomization Participants will be randomized 1:1 to one of two measurement sequences: (1) seated first followed by Fowler, or (2) Fowler first followed by seated. The method used is random block generation, to account for the relatively small size of the study population.
Outcome Measure Primary outcome: Mean paired difference in systolic blood pressure between Fowler and seated positions.
Sample Size Calculation Assuming a standard deviation of paired differences of 9 mmHg, an equivalence margin of ±5 mmHg, a two-sided alpha of 0.01, and 95% power, a minimum of 120 participants is required. This will yield 240 observations between the two positions.
Statistical Analysis Analyses will be performed according to a per-protocol principle, as recommended for equivalence trials.
The mean paired difference (Fowler - seated, seated - Fowler) will be calculated for each participant.
Equivalence will be assessed using the TOST procedure. A 99% confidence interval (CI) for the mean paired SBP difference will be constructed. Equivalence will be concluded if the entire CI lies within the predefined equivalence margin of ±5 mmHg.
Normality of paired differences will be evaluated using the Shapiro-Wilk test. If violated, bootstrap confidence intervals (10,000 resamples) will be used.
All tests will be two-sided with significance level α = 0.01. Ethical Considerations The study will be conducted in accordance with the Declaration of Helsinki. All participants will provide written informed consent prior to participation.
Data Management Data will be collected anonymously and stored securely. Only study investigators will have access to the final dataset.
- Conditions
- Blood Pressure Measurement
- Being tested
- blood pressure measurement in the semi-recumbent position, Standard BP measurement
- Keywords
- blood pressure, methodology, equivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood pressure measurement in the semi-recumbent positionOther
Blood pressure measurement , with the investigational variable being the position of the body of the patient
Standard BP measurementOther
Standardized BP measurement, in the seated, back-supported position
| Study group | Role | What they receive |
|---|---|---|
| Seated BP | Active comparator | standardised BP measurement Receives: Other: Standard BP measurement |
| Fowler BP | Experimental | The same protocol as per standard measurement, with the patient in the semi-recumbent position (Fowler position), at a 30 degree angle of the head of the bed Receives: Other: blood pressure measurement in the semi-recumbent position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean paired difference in systolic blood pressure
Primary outcome: Mean paired difference in systolic blood pressure between Fowler and seated positions.
Measured: 25-30 minutes
Secondary outcomes (1)
BP equivalence in specific populations
Identification of patient groups/ populations where the seated vs fowler would be considereed as equal
Measured: 20-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion10 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
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 Blood Pressure MeasurementStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mihai Lupu, MD, PhD, Assistant Professor, Study chair, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878858
- Sponsor's protocol ID
- RCT144095
- Acronym
- POSE-SBP
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: BP measurements, Demographic data, Medical History, and further data, on reasonable request
Publications
Cicolini G, Pizzi C, Palma E, Bucci M, Schioppa F, Mezzetti A, Manzoli L. Differences in blood pressure by body position (supine, Fowler's, and sitting) in hypertensive subjects. Am J Hypertens. 2011 Oct;24(10):1073-9. doi: 10.1038/ajh.2011.106. Epub 2011 Jun 16.
PubMed 21677699
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equivalence of Systolic Blood Pressure Measurements Between Fowler and Seated Positions: A Randomized Paired Equivalence Trial
- ClinicalTrials.gov ID
- NCT07878858
- Acronym / sponsor ID
- POSE-SBP / RCT144095
- Conditions
- Blood Pressure Measurement
- Keywords
- blood pressure, methodology, equivalence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 16 Oct 2026 (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.
Blood pressure is an important part of checking heart health. Blood pressure is usually measured while sitting, but in everyday medical care it is sometimes measured in other positions, such as the Fowler position, where the upper body is raised. This study will compare blood pressure measured while sitting with blood pressure measured in the Fowler position to see whether the results are similar enough to be considered equivalent. Adults aged 18 or older who can give informed consent and have an arm circumference of 22-42 cm may take part. Each participant will have their blood pressure measured in both positions, with the order chosen randomly. People who cannot maintain the required positions or whose condition could affect the accuracy of the blood pressure measurement will not take part.
Detailed description
Background and Rationale Blood pressure (BP) measurement is a cornerstone of cardiovascular assessment. Standard guidelines recommend seated BP measurements; however, in routine clinical practice, measurements are frequently obtained in alternative positions such as the Fowler position. This study aims to determine whether SBP measurements obtained in the Fowler position are clinically equivalent to those obtained in the seated position.
Objectives The primary objective is to determine whether SBP measured in the Fowler position is equivalent to SBP measured in the seated position within a predefined clinical equivalence margin of ±5 mmHg.
Hypothesis Null hypothesis: The mean paired difference in SBP between Fowler and seated positions is outside the equivalence margin of ±5 mmHg.
Alternative hypothesis: The mean paired difference in SBP between Fowler and seated positions lies within the equivalence margin of ±5 mmHg.
Study Design This is a prospective, randomized, paired equivalence trial. Each participant will undergo SBP measurement in both seated and Fowler positions, with the order of positions randomized.
Setting Outpatient cardiology clinic. Blood Pressure Measurement Protocol Blood pressure will be measured using a validated automated OMRON device. For each position, three consecutive (1 minute apart) SBP measurements will be obtained and averaged. A rest period of 5 minutes will be observed after changing position before measurements, with a 5-minute rest period before the first BP measurement. The same arm and appropriately sized cuff will be used for all measurements.
Seated position
- Back supported
- Feet flat on the floor
- Legs uncrossed
- Arm supported at mid-sternal (right atrial) level Fowler position
- Semi-recumbent position with trunk elevated at 30° measured using an inclinometer
- Knees extended
- Back supported
Randomization Participants will be randomized 1:1 to one of two measurement sequences: (1) seated first followed by Fowler, or (2) Fowler first followed by seated. The method used is random block generation, to account for the relatively small size of the study population.
Outcome Measure Primary outcome: Mean paired difference in systolic blood pressure between Fowler and seated positions.
Sample Size Calculation Assuming a standard deviation of paired differences of 9 mmHg, an equivalence margin of ±5 mmHg, a two-sided alpha of 0.01, and 95% power, a minimum of 120 participants is required. This will yield 240 observations between the two positions.
Statistical Analysis Analyses will be performed according to a per-protocol principle, as recommended for equivalence trials.
The mean paired difference (Fowler - seated, seated - Fowler) will be calculated for each participant.
Equivalence will be assessed using the TOST procedure. A 99% confidence interval (CI) for the mean paired SBP difference will be constructed. Equivalence will be concluded if the entire CI lies within the predefined equivalence margin of ±5 mmHg.
Normality of paired differences will be evaluated using the Shapiro-Wilk test. If violated, bootstrap confidence intervals (10,000 resamples) will be used.
All tests will be two-sided with significance level α = 0.01. Ethical Considerations The study will be conducted in accordance with the Declaration of Helsinki. All participants will provide written informed consent prior to participation.
Data Management Data will be collected anonymously and stored securely. Only study investigators will have access to the final dataset.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seated BP | Active comparator | Other: Standard BP measurementstandardised BP measurement |
| Fowler BP | Experimental | Other: blood pressure measurement in the semi-recumbent positionThe same protocol as per standard measurement, with the patient in the semi-recumbent position (Fowler position), at a 30 degree angle of the head of the bed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥18 years
- Arm circumference 22-42 cm
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- Inability to maintain required positions
- Pregnancy
- Any condition interfering with accurate BP measurement (i.e., atrial fibrillation)
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 |
|---|---|---|
| blood pressure measurement in the semi-recumbent positionBlood pressure measurement , with the investigational variable being the position of the body of the patient | Other | Fowler BP |
| Standard BP measurementStandardized BP measurement, in the seated, back-supported position | Other | Seated BP |
Primary outcome
Mean paired difference in systolic blood pressure
Time frame: 25-30 minutes
Primary outcome: Mean paired difference in systolic blood pressure between Fowler and seated positions.
1 secondary outcome
BP equivalence in specific populations
Time frame: 20-30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 21677699Cicolini G, Pizzi C, Palma E, Bucci M, Schioppa F, Mezzetti A, Manzoli L. Differences in blood pressure by body position (supine, Fowler's, and sitting) in hypertensive subjects. Am J Hypertens. 2011 Oct;24(10):1073-9. doi: 10.1038/ajh.2011.106. Epub 2011 Jun 16.
- Individual participant dataSharing planned: Yes. BP measurements, Demographic data, Medical History, and further data, on reasonable request
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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.
Mihai Lupu, MD, PhD, Assistant Professor study chair
Iuliu Hatieganu University of Medicine and Pharmacy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood pressure measurement in the semi-recumbent position and Standard BP measurement in people with Blood Pressure Measurement, run by Iuliu Hatieganu University of Medicine and Pharmacy at 2 sites in Romania.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mihai Lupu, MD, PhD, Assistant Professor (România ext. +40755022572, lupu.mihai@umfcluj.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean paired difference in systolic blood pressure (time frame: 25-30 minutes). 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 NCT07878858, 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 29 Oct 2026.