Personal Activity Intelligence in the Treatment of High Blood Pressure

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.

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Behavioral: Personal Activity Intelligence; Behavioral: Physical Activity Guidelines

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • NTNU Department of Circulation and Medical Imaging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; 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.	Behavioral: Personal Activity Intelligence; 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.
Active Comparator: Control; The control group is recommended to follow national PA guidelines, which can be considered as the 'intervention' offered to the public.	Behavioral: Physical Activity Guidelines; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Investigators: Study Director: Øystein Risa, NTNU, Department of Circulation and Medical Imaging; Principal Investigator: Ulrik Wisløff, PhD, NTNU, Department of Circulation and Medical Imaging

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Actual): May 19, 2020
• Study Completion (Actual): May 19, 2020

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: November 2, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Hypertension; Exercise Therapy; Blood Pressure Monitoring, Ambulatory; Physical activity monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: 2019/1084

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No