Clinical trial NCT03270202: Wearable Devices to Promote Physical Activity
Official title: The HUNT 4 PAI Study: A Randomized Controlled Intervention Study Using Wearable Devices to Promote Physical Activity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Exercise
Cardiorespiratory fitness
Risk factors
Monitoring, physiologic
Monitoring, ambulatory
Prognosis
Norway
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 175
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak oxygen uptake (VO2peak)
timeFrame: 16 weeks
Secondary outcomes:
measure: Peak oxygen uptake (VO2peak)
timeFrame: 1 year
measure: Cardiovascular risk profile (ESC Score)
timeFrame: 16 weeks
measure: Cardiovascular risk profile (ESC Score)
timeFrame: 1 year
measure: Structural and functional cardiac changes
timeFrame: 16 weeks
measure: Structural and functional cardiac changes
timeFrame: 1 year
measure: Quality of life
timeFrame: 16 weeks
measure: Quality of life
timeFrame: 1 year
measure: Adherence to prescribed physical activity
timeFrame: 16 weeks
measure: Adherence to prescribed physical activity
timeFrame: 1 year
measure: Feedback from users
timeFrame: 16 weeks
measure: Feedback from users
timeFrame: 1 year
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Circulation and Medical Imaging
Study officials:
affiliation: Norwegian University of Science and Technology
name: Øystein Risa, phd
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology
name: Bjarne Martens Nes, phd
role: PRINCIPAL_INVESTIGATOR
References: