Wearable Devices to Promote Physical Activity

Cardiovascular Diseases Clinical Trial

— HUNT4-PAI  

Official title:

The HUNT 4 PAI Study: A Randomized Controlled Intervention Study Using Wearable Devices to Promote Physical Activity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03270202
• Other study ID #: 2016/2300
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 17, 2018

Study information

• Verified date: November 2018
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 175
• Est. completion date: October 17, 2018
• Est. primary completion date: October 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• PAI group
physical activity defined as 100 weekly PAI during 1 year smartphone application and a user-friendly activity wristband (Mio PAI Slice)
• Usual care
Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.

Locations

Country	Name	City	State
Norway	Department of Circulation and Medical Imaging	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak oxygen uptake (VO2peak)	Measured by ergospirometry during a maximal treadmill protocol to exhaustion	16 weeks
Secondary	Peak oxygen uptake (VO2peak)	Measured by ergospirometry during a maximal treadmill protocol to exhaustion	1 year
Secondary	Cardiovascular risk profile (ESC Score)	Measured by blood samples and clinical data	16 weeks
Secondary	Cardiovascular risk profile (ESC Score)	Measured by blood samples and clinical data	1 year
Secondary	Structural and functional cardiac changes	Measured by echocardiography and CT coronary angiography	16 weeks
Secondary	Structural and functional cardiac changes	Measured by echocardiography and CT coronary angiography	1 year
Secondary	Quality of life	Measured by questionnaire SF-36	16 weeks
Secondary	Quality of life	Measured by questionnaire SF-36	1 year
Secondary	Adherence to prescribed physical activity	Measured by Mio Slice	16 weeks
Secondary	Adherence to prescribed physical activity	Measured by Mio Slice	1 year
Secondary	Feedback from users	Measured by interviews and feedback systems	16 weeks
Secondary	Feedback from users	Measured by interviews and feedback systems	1 year