Wearable Devices to Promote Physical Activity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: PAI group
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 23 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAI group<br>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<br>* physical activity defined as 100 weekly PAI during 1 year smartphone application and a user-friendly activity wristband (Mio PAI Slice)<br>Behavioral: Usual care<br>* Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.<br>|
| Active Comparator: Usual care<br>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<br>* Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prognosis, Exercise, Cardiorespiratory fitness, Risk factors, Monitoring, physiologic, Monitoring, ambulatory, Norway