Cardiovascular DiseasesHUNT4-PAINCT03270202
Wearable Devices to Promote Physical Activity
A study testing PAI group in people with Cardiovascular Diseases, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- PAI group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2017to 17 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participated in HUNT 3 and HUNT 4 Fitness Study
- VO2peak in HUNT4 in the lowest sex- and age-specific tertile.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The HUNT 4 PAI Study: A Randomized Controlled Intervention Study Using Wearable Devices to Promote Physical Activity
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- PAI group, Usual care
- Keywords
- Exercise, Cardiorespiratory fitness, Risk factors, Monitoring, physiologic, Monitoring, ambulatory, Prognosis, Norway
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAI groupBehavioural
- physical activity defined as 100 weekly PAI during 1 year
- smartphone application and a user-friendly activity wristband (Mio PAI Slice)
Usual careBehavioural
Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.
| Study group | Role | What they receive |
|---|---|---|
| PAI group | Experimental | 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. Receives: Behavioral: PAI group; Behavioral: Usual care |
| Usual care | Active comparator | 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. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake (VO2peak)
Measured by ergospirometry during a maximal treadmill protocol to exhaustion
Measured: 16 weeks
Secondary outcomes (11)
Peak oxygen uptake (VO2peak)
Measured by ergospirometry during a maximal treadmill protocol to exhaustion
Measured: 1 year
Cardiovascular risk profile (ESC Score)
Measured by blood samples and clinical data
Measured: 16 weeks
Cardiovascular risk profile (ESC Score)
Measured by blood samples and clinical data
Measured: 1 year
Structural and functional cardiac changes
Measured by echocardiography and CT coronary angiography
Measured: 16 weeks
Structural and functional cardiac changes
Measured by echocardiography and CT coronary angiography
Measured: 1 year
Quality of life
Measured by questionnaire SF-36
Measured: 16 weeks
Quality of life
Measured by questionnaire SF-36
Measured: 1 year
Adherence to prescribed physical activity
Measured by Mio Slice
Measured: 16 weeks
Adherence to prescribed physical activity
Measured by Mio Slice
Measured: 1 year
Feedback from users
Measured by interviews and feedback systems
Measured: 16 weeks
Feedback from users
Measured by interviews and feedback systems
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Oct 2017
- Primary completion17 Oct 2018
- Study completion17 Oct 2018
Why it stopped: discontinuation of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Øystein Risa, phd, Study director, Norwegian University of Science and TechnologyBjarne Martens Nes, phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270202
- Sponsor's protocol ID
- 2016/2300
- Acronym
- HUNT4-PAI
- Status last verified
- Nov 2018
- First submitted
- 30 Aug 2017
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HUNT 4 PAI Study: A Randomized Controlled Intervention Study Using Wearable Devices to Promote Physical Activity
- ClinicalTrials.gov ID
- NCT03270202
- Acronym / sponsor ID
- HUNT4-PAI / 2016/2300
- Conditions
- Cardiovascular Diseases
- Keywords
- Exercise, Cardiorespiratory fitness, Risk factors, Monitoring, physiologic, Monitoring, ambulatory, Prognosis, Norway
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: discontinuation of financial support
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 17 Oct 2018 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAI group | Experimental | Behavioral: PAI group, Behavioral: Usual careParticipants 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 | Active comparator | Behavioral: Usual careUsual 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. |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participated in HUNT 3 and HUNT 4 Fitness Study
- VO2peak in HUNT4 in the lowest sex- and age-specific tertile.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAI group* physical activity defined as 100 weekly PAI during 1 year * smartphone application and a user-friendly activity wristband (Mio PAI Slice) | Behavioural | PAI group |
| Usual careParticipants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities. | Behavioural | PAI group, Usual care |
Primary outcome
Peak oxygen uptake (VO2peak)
Time frame: 16 weeks
Measured by ergospirometry during a maximal treadmill protocol to exhaustion
11 secondary outcomes
Peak oxygen uptake (VO2peak)
Time frame: 1 year
Cardiovascular risk profile (ESC Score)
Time frame: 16 weeks
Cardiovascular risk profile (ESC Score)
Time frame: 1 year
Structural and functional cardiac changes
Time frame: 16 weeks
Structural and functional cardiac changes
Time frame: 1 year
Quality of life
Time frame: 16 weeks
Quality of life
Time frame: 1 year
Adherence to prescribed physical activity
Time frame: 16 weeks
Adherence to prescribed physical activity
Time frame: 1 year
Feedback from users
Time frame: 16 weeks
Feedback from users
Time frame: 1 year
Results and safety
The study was stopped early (reason given: discontinuation of financial support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øystein Risa, phd study director
Norwegian University of Science and Technology
Bjarne Martens Nes, phd principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAI group in people with Cardiovascular Diseases, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: discontinuation of financial support). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (VO2peak) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.