Cardiovascular Diseases
Conditions
Keywords
Exercise, Cardiorespiratory fitness, Risk factors, Monitoring, physiologic, Monitoring, ambulatory, Prognosis, Norway
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.
Interventions
BEHAVIORALPAI group
* physical activity defined as 100 weekly PAI during 1 year * smartphone application and a user-friendly activity wristband (Mio PAI Slice)
BEHAVIORALUsual care
Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.
Sponsors
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
23 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak oxygen uptake (VO2peak) | 16 weeks | Measured by ergospirometry during a maximal treadmill protocol to exhaustion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular risk profile (ESC Score) | 16 weeks | Measured by blood samples and clinical data |
| Structural and functional cardiac changes | 16 weeks | Measured by echocardiography and CT coronary angiography |
| Peak oxygen uptake (VO2peak) | 1 year | Measured by ergospirometry during a maximal treadmill protocol to exhaustion |
| Adherence to prescribed physical activity | 16 weeks | Measured by Mio Slice |
| Feedback from users | 16 weeks | Measured by interviews and feedback systems |
| Quality of life | 16 weeks | Measured by questionnaire SF-36 |
Countries
Norway
Outcome results
None listed