Personal Activity Intelligence in the Treatment of High Blood Pressure

NCT04151537 | Completed

• 1 other identifier: 2019/1084
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension

Keywords

Hypertension; Exercise Therapy; Blood Pressure Monitoring, Ambulatory; Physical activity monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Office blood pressure

  Pre- to postintervention (12 weeks)

• Arterial stiffness

  Pre- to postintervention (12 weeks)

• Cardiac function

  Pre- to postintervention (12 weeks)

• Cardiorespiratory fitness

  Pre- to postintervention (12 weeks)

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Control

ACTIVE COMPARATOR

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

Interventions

Personal Activity Intelligence BEHAVIORAL

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.

Intervention

Physical Activity Guidelines BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Not currently engaged in regular physical activity (\< 50 PAI per week based on self-reported PA)

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

NTNU Department of Circulation and Medical Imaging

Trondheim, Norway

Location

Related Publications (1)

• 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.

  PMID: 27984009 BACKGROUND

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ulrik Wisløff, PhD

  NTNU, Department of Circulation and Medical Imaging

  PRINCIPAL INVESTIGATOR

• Øystein Risa

  NTNU, Department of Circulation and Medical Imaging

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: November 5, 2019
• Study Start: October 21, 2019
• Primary Completion: May 19, 2020
• Study Completion: May 19, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

NO (1)