Wearable Devices to Promote Physical Activity (HUNT4-PAI)

The HUNT 4 PAI Study: A Randomized Controlled Intervention Study Using Wearable Devices to Promote Physical Activity

This study evaluates the effect of a new wearable device, that measures physical activity level based on heart rates, on relevant health outcomes including cardiorespiratory fitness. Half of participants will be instructed in using the Mio Slice wristband, while the other half will be requested to follow today's recommendations for physical activity.

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: PAI group; Behavioral: Usual care

Detailed Description

Two critical challenges precluding the full potential of physical activity in preventive healthcare are: 1) The majority of people are not sufficiently active, and 2) there is a lack of large, long-term intervention studies documenting the effect of personalized activity and improved health in the population. Using HUNT data an algorithm called Personal Activity Intelligence (PAI) has been developed. PAI was integrated in a smartphone application and user friendly wristband (Mio Slice), that measures heart rate continuously and estimates an individual threshold for total physical activity (defined as 100 weekly PAI) that is associated with reduced risk of cardiovascular disease and mortality. The primary aim of the study is to reveal whether using the wristband will increase cardiorespiratory fitness, determined by maximal oxygen uptake, after 4 months among low-fit participants. The secondary aims includes the effect on reversing cardiovascular risk factors, cardiac structure and function, adherence to physical activity and identification of barriers after 16 weeks and 1 year.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participated in HUNT 3 and HUNT 4 Fitness Study
• VO2peak in HUNT4 in the lowest sex- and age-specific tertile.

Exclusion Criteria:

• Illness or disabilities that preclude completion of the study or make exercise contraindicated
• uncontrolled hypertension, arrhythmias or angina
• heart failure
• primary pulmonary hypertension
• diagnosed dementia
• chronic communicable infectious diseases
• participation in conflicting interventions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAI group; Participants randomized to the PAI-group will receive a wearable device (Mio Slice PAI wristband) that measure heart rate continuously and via an algorithm calculates a physical activity score called PAI. The weekly goal of 100 PAI can be reached by a combination of different intensities and durations and the participants will get continuous information about their current score and amount of activity needed to reach the goal. 100 PAI is expected to approximate current guidelines of 150 minutes of moderate intensity or 75 minutes of vigorous intensity for the average participant or somewhat less if the intensity of the chosen activity is high. Proper instruction in use of the device and App will be given both oral and written after baseline testing and randomization.	Behavioral: PAI group; physical activity defined as 100 weekly PAI during 1 year; smartphone application and a user-friendly activity wristband (Mio PAI Slice); Behavioral: Usual care; Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.
Active Comparator: Usual care; Usual care: Participants in the control group will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.	Behavioral: Usual care; Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak oxygen uptake (VO2peak)	Measured by ergospirometry during a maximal treadmill protocol to exhaustion	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak oxygen uptake (VO2peak)	Measured by ergospirometry during a maximal treadmill protocol to exhaustion	1 year
Cardiovascular risk profile (ESC Score)	Measured by blood samples and clinical data	16 weeks
Cardiovascular risk profile (ESC Score)	Measured by blood samples and clinical data	1 year
Structural and functional cardiac changes	Measured by echocardiography and CT coronary angiography	16 weeks
Structural and functional cardiac changes	Measured by echocardiography and CT coronary angiography	1 year
Quality of life	Measured by questionnaire SF-36	16 weeks
Quality of life	Measured by questionnaire SF-36	1 year
Adherence to prescribed physical activity	Measured by Mio Slice	16 weeks
Adherence to prescribed physical activity	Measured by Mio Slice	1 year
Feedback from users	Measured by interviews and feedback systems	16 weeks
Feedback from users	Measured by interviews and feedback systems	1 year

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Investigators: Principal Investigator: Bjarne Martens Nes, phd, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): October 17, 2018
• Study Completion (Actual): October 17, 2018

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Exercise; Prognosis; Risk factors; Cardiorespiratory fitness; Norway; Monitoring, physiologic; Monitoring, ambulatory
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2016/2300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: After the study ends all data from baseline and follow-up testing will be transferred to HUNT databank and made available for other researchers.
• IPD Sharing Time Frame: Data will be available within 6 months after study completion with no time-frame restriction.
• IPD Sharing Access Criteria: Data will be available for national and international institutions after contract with HUNT Research Center and includes a fee.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

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