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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | The 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. |
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| Control | Active Comparator | The control group is recommended to follow national PA guidelines, which can be considered as the 'intervention' offered to the public. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre- to postintervention (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre- to postintervention (12 weeks) |
| Arterial stiffness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrik Wisløff, PhD | NTNU, Department of Circulation and Medical Imaging | Principal Investigator |
| Øystein Risa | NTNU, Department of Circulation and Medical Imaging | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NTNU Department of Circulation and Medical Imaging | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27984009 | Background | 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. |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. |
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Change in carotid to femoral pulse wave velocity (m/s). Arterial stiffness is measured non-invasive with a validated Pulse Wave Velocity System. |
| Pre- to postintervention (12 weeks) |
| Cardiac function | Change in stroke volume (L/beat). Cardiac function is measured with echocardiography by qualified physician or ultrasound technician . | Pre- to postintervention (12 weeks) |
| 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. | Pre- to postintervention (12 weeks) |