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NCT Number: NCT04151537

Personal Activity Intelligence in the Treatment of High Blood Pressure

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NTNU Department of Circulation and Medical Imaging

Trondheim, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Personal Activity Intelligence

Behavioral

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 Guidelines

Behavioral

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.

Primary outcomes

  1. 24 hour blood pressure

    Time frame: Pre- to postintervention (12 weeks)

    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.

Secondary outcomes

  1. Office blood pressure

    Time frame: Pre- to postintervention (12 weeks)

    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.

  2. Arterial stiffness

    Time frame: Pre- to postintervention (12 weeks)

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

  3. Cardiac function

    Time frame: Pre- to postintervention (12 weeks)

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

  4. Cardiorespiratory fitness

    Time frame: Pre- to postintervention (12 weeks)

    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.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2019
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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