Personal Activity Intelligence in the Treatment of High Blood Pressure

Norwegian University of Science and Technology

Status: Completed

Conditions: Essential Hypertension

Treatments: Behavioral: Personal Activity Intelligence; Behavioral: Physical Activity Guidelines

Study type: Interventional

Funder types: Other

Identifiers

NCT04151537

2019/1084

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 45 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

26 participants in 2 patient groups

Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Personal Activity Intelligence

Control

Active Comparator group

Description:

The control group is recommended to follow national PA guidelines, which can be considered as the 'intervention' offered to the public.

Treatment:

Behavioral: Physical Activity Guidelines