MedDataX Logo

Wearable Devices to Promote Physical Activity

NCT ID: NCT03270202

Last Updated: 2018-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-10-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Exercise Cardiorespiratory fitness Risk factors Monitoring, physiologic Monitoring, ambulatory Prognosis Norway

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PAI group

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.

Group Type EXPERIMENTAL

PAI group

Intervention Type BEHAVIORAL

* physical activity defined as 100 weekly PAI during 1 year
* smartphone application and a user-friendly activity wristband (Mio PAI Slice)

Usual care

Intervention Type BEHAVIORAL

Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.

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.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PAI group

* physical activity defined as 100 weekly PAI during 1 year
* smartphone application and a user-friendly activity wristband (Mio PAI Slice)

Intervention Type BEHAVIORAL

Usual care

Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Øystein Risa, phd

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Bjarne Martens Nes, phd

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Circulation and Medical Imaging

Trondheim, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016/2300

Identifier Type: -

Identifier Source: org_study_id