Clinical trial NCT04151537: Personal Activity Intelligence in the Treatment of High Blood Pressure
Official title: Personal Activity Intelligence (PAI) in the Treatment of High Blood Pressure: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Hypertension
Keywords: Hypertension
Exercise Therapy
Blood Pressure Monitoring, Ambulatory
Physical activity monitoring
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 26
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: 24 hour blood pressure
timeFrame: Pre- to postintervention (12 weeks)
Secondary outcomes:
measure: Office blood pressure
timeFrame: Pre- to postintervention (12 weeks)
measure: Arterial stiffness
timeFrame: Pre- to postintervention (12 weeks)
measure: Cardiac function
timeFrame: Pre- to postintervention (12 weeks)
measure: Cardiorespiratory fitness
timeFrame: Pre- to postintervention (12 weeks)
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: NTNU Department of Circulation and Medical Imaging
Study officials:
affiliation: NTNU, Department of Circulation and Medical Imaging
name: Ulrik Wisløff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NTNU, Department of Circulation and Medical Imaging
name: Øystein Risa
role: STUDY_DIRECTOR
References:
citation: 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.