Personal Activity Intelligence in the Treatment of High Blood Pressure

NCT ID: NCT04151537

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-21
• Study Completion Date: 2020-05-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Personal Activity Intelligence

Intervention Type: 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.

Control

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

Group Type: ACTIVE_COMPARATOR

Physical Activity Guidelines

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulrik Wisløff, PhD

Role: PRINCIPAL_INVESTIGATOR

NTNU, Department of Circulation and Medical Imaging

Øystein Risa

Role: STUDY_DIRECTOR

NTNU, Department of Circulation and Medical Imaging

Locations

NTNU Department of Circulation and Medical Imaging

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: BACKGROUND

PMID: 27984009 (View on PubMed)

Other Identifiers

2019/1084

Identifier Type: -

Identifier Source: org_study_id