Clinical Trials Directory

Trials / Completed

CompletedNCT04151537

Personal Activity Intelligence in the Treatment of High Blood Pressure

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
26 (actual)
Sponsor
Norwegian University of Science and Technology · Academic / Other
Sex
All
Age
45 Years – 64 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPersonal Activity IntelligenceThe 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.
BEHAVIORALPhysical Activity GuidelinesThe 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.

Timeline

Start date
2019-10-21
Primary completion
2020-05-19
Completion
2020-05-19
First posted
2019-11-05
Last updated
2020-10-19

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT04151537. Inclusion in this directory is not an endorsement.