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Essential HypertensionNCT04151537

Personal Activity Intelligence in the Treatment of High Blood Pressure

A study testing Personal Activity Intelligence and Physical Activity Guidelines in people with Essential Hypertension, run by Norwegian University of Science and Technology at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Personal Activity Intelligence (PAI) is a novel metric developed to quantify the amount of routine physical activity (PA) needed to improve health and reduce cardiovascular (CV) mortality. The PAI metric can be integrated in PA monitors to promote and track PA. Read more about this study

Who is it for?
Ages 45 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Essential Hypertension
What is being tested?
Personal Activity Intelligence and Physical Activity Guidelines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteNorway
Study dates
21 Oct 2019to 19 May 2020
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 45 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Systolic blood pressure (SBP) 130-179 mmHg and/or diastolic blood pressure (DBP) 80-109 mmHg at first clinical visit (screening). Note, this criteria was updated after the inclusion of three participants. The initial inclusion criteria were SBP 140-179 mmHg and/or DBP 90-109 mmHg.
  • Not currently engaged in regular physical activity (< 50 PAI per week based on self-reported PA)

Who cannot join

  • Usage of blood pressure medication
  • Usage of lipid modifying agents
  • Diabetes
  • Cardiovascular disease
  • Diagnosed secondary hypertension
  • Disease or disability that prevent exercise or participation in testing

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • NTNU Department of Circulation and Medical Imaging

    Trondheim

Other trials in Norway

About this study

Official title: Personal Activity Intelligence (PAI) in the Treatment of High Blood Pressure: A Pilot Study

Personal Activity Intelligence (PAI) is a novel metric developed to quantify the amount of routine physical activity (PA) needed to improve health and reduce cardiovascular (CV) mortality. The PAI metric can be integrated in PA monitors to promote and track PA. The present pilot study is a 12-week randomized controlled trial designed to test the efficacy of PAI in the treatment of high blood pressure. The primary aim is to investigate how routine PA (expressed as PAI level) affect ambulatory blood pressure by comparing the effect of the intervention (≥100 PAI per week) with a control recommended to follow national PA guidelines. The secondary aims are to investigate the effect on a comprehensive CV risk profile, and to model the effect of PAI level on multiple CV parameters. The CV risk profile includes office BP, arterial stiffness, stroke volume, heart rate, cardiac output, systemic vascular resistance, cardiorespiratory fitness, body composition, blood lipid profile and serum markers of glucose metabolism, kidney failure and systemic inflammation.

Being tested
Personal Activity Intelligence, Physical Activity Guidelines
Keywords
Hypertension, Exercise Therapy, Blood Pressure Monitoring, Ambulatory, Physical activity monitoring
Medical subject headings
Essential Hypertension, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personal Activity IntelligenceBehavioural

    The intervention group is provided with a PAI monitor (wristband) with a user interface (app) to track their own PAI level and are instructed to obtain at least 100 PAI on a weekly basis.

  • Physical Activity GuidelinesBehavioural

    The control group is recommended to follow national PA guidelines, meaning 150 minutes of moderate-intensity PA or 75 minutes of vigorous-intensity PA, or a combination there of. The control group is provided with a PAI monitor (wristband) without any user interface and are thus blinded to track their own PAI level.

Study groups in NCT04151537
Study groupRoleWhat they receive
InterventionActive comparatorThe intervention group is provided with a PA tracker that enables self-monitoring of PA and are instructed to obtain a personalized PA goal on a weekly basis.
Receives: Behavioral: Personal Activity Intelligence
ControlActive comparatorThe control group is recommended to follow national PA guidelines, which can be considered as the 'intervention' offered to the public.
Receives: Behavioral: Physical Activity Guidelines

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24 hour blood pressure

    Change in average systolic and diastolic blood pressure over 24 hours (mmHg). 24h blood pressure is measured automatically 2-3 times per hour with an oscillometric ambulatory blood pressure monitor.

    Measured: Pre- to postintervention (12 weeks)

Secondary outcomes (4)

  1. Office blood pressure

    Change in average systolic and diastolic blood pressure at clinical visits (mmHg).

    Office blood pressure is measured automatically 2-3 times after 5 minutes of rest with an oscillometric blood pressure monitor at an unattended clinical office.

    Measured: Pre- to postintervention (12 weeks)

  2. Arterial stiffness

    Change in carotid to femoral pulse wave velocity (m/s). Arterial stiffness is measured non-invasive with a validated Pulse Wave Velocity System.

    Measured: Pre- to postintervention (12 weeks)

  3. Cardiac function

    Change in stroke volume (L/beat). Cardiac function is measured with echocardiography by qualified physician or ultrasound technician .

    Measured: Pre- to postintervention (12 weeks)

  4. Cardiorespiratory fitness

    Change in maximal oxygen uptake per kg body mass (ml/min/kg). Cardiorespiratory fitness measured directly with cardiopulmonary exercise testing on a treadmill until maximal effort.

    Measured: Pre- to postintervention (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2019
  2. Study start21 Oct 2019
  3. Primary completion19 May 2020
  4. Study completion19 May 2020

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04151537
Sponsor's protocol ID
2019/1084
Status last verified
Oct 2020
First submitted
24 Oct 2019
Last updated
19 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nes BM, Gutvik CR, Lavie CJ, Nauman J, Wisloff U. Personalized Activity Intelligence (PAI) for Prevention of Cardiovascular Disease and Promotion of Physical Activity. Am J Med. 2017 Mar;130(3):328-336. doi: 10.1016/j.amjmed.2016.09.031. Epub 2016 Oct 29.

    PubMed 27984009

Questions about this trial

What is this clinical trial studying?

A study testing Personal Activity Intelligence and Physical Activity Guidelines in people with Essential Hypertension, run by Norwegian University of Science and Technology at 1 site in Norway.

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 2 inclusion and 6 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 19 Oct 2020. 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 Norway. 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?

24 hour blood pressure (time frame: Pre- to postintervention (12 weeks)). 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 NCT04151537, 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 19 Oct 2020.

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