Personal Activity Intelligence in the Treatment of High Blood Pressure

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04151537
• Other study ID #: 2019/1084
• Status: Completed
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: May 19, 2020

Study information

• Verified date: October 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 19, 2020
• Est. primary completion date: May 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	NTNU Department of Circulation and Medical Imaging	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Nes BM, Gutvik CR, Lavie CJ, Nauman J, Wisløff 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)