Wearable Devices to Promote Physical Activity

Not Applicable

Terminated

• Conditions: Cardiovascular Diseases
• Interventions: Behavioral: PAI group; Behavioral: Usual care

• Registration Number: NCT03270202
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-09-01
• Study Start: 2017-10-01
• Primary Completion: 2018-10-17
• Study Completion: 2018-10-17
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 175

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAI group	Usual care	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.
Usual care	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.
PAI group	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.

Primary Outcome Measures

Name	Time	Method
Peak oxygen uptake (VO2peak)	16 weeks	Measured by ergospirometry during a maximal treadmill protocol to exhaustion

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Circulation and Medical Imaging; 🇳🇴 Trondheim, Norway