An interventional study of PAI group and Usual care in Cardiovascular Diseases, sponsored by Norwegian University of Science and Technology. Terminated at 1 site in Norway. Open to participants aged 23 Years and older. Per ClinicalTrials.gov, last updated 2018-11-30.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Prevention
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.
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.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's enrollment of 175 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Norwegian University of Science and Technology is the lead sponsor of 495 studies on the registry; 48 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Behavioral: 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
* physical activity defined as 100 weekly PAI during 1 year * smartphone application and a user-friendly activity wristband (Mio PAI Slice)
Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.
Peak oxygen uptake (VO2peak)
Measured by ergospirometry during a maximal treadmill protocol to exhaustion
Time frame: 16 weeks
Peak oxygen uptake (VO2peak)
Measured by ergospirometry during a maximal treadmill protocol to exhaustion
Time frame: 1 year
Cardiovascular risk profile (ESC Score)
Measured by blood samples and clinical data
Time frame: 16 weeks
Cardiovascular risk profile (ESC Score)
Measured by blood samples and clinical data
Time frame: 1 year
Structural and functional cardiac changes
Measured by echocardiography and CT coronary angiography
Time frame: 16 weeks
Structural and functional cardiac changes
Measured by echocardiography and CT coronary angiography
Time frame: 1 year
Quality of life
Measured by questionnaire SF-36
Time frame: 16 weeks
Quality of life
Measured by questionnaire SF-36
Time frame: 1 year
Adherence to prescribed physical activity
Measured by Mio Slice
Time frame: 16 weeks
Adherence to prescribed physical activity
Measured by Mio Slice
Time frame: 1 year
Feedback from users
Measured by interviews and feedback systems
Time frame: 16 weeks
Feedback from users
Measured by interviews and feedback systems
Time frame: 1 year
Plan to share: Yes — After the study ends all data from baseline and follow-up testing will be transferred to HUNT databank and made available for other researchers.
Supporting information: Study protocol, Informed consent form
Time frame: Data will be available within 6 months after study completion with no time-frame restriction.
Access criteria: Data will be available for national and international institutions after contract with HUNT Research Center and includes a fee.
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Oct 2018, 12 months.
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This study is terminated, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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