NCT03270202

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2018

Completed
Last Updated

November 30, 2018

Status Verified

November 1, 2018

Enrollment Period

1 year

First QC Date

August 30, 2017

Last Update Submit

November 28, 2018

Conditions

Cardiovascular Diseases

Keywords

ExerciseCardiorespiratory fitnessRisk factorsMonitoring, physiologicMonitoring, ambulatoryPrognosisNorway

Outcome Measures

Primary Outcomes (1)

  • Peak oxygen uptake (VO2peak)

    Measured by ergospirometry during a maximal treadmill protocol to exhaustion

    16 weeks

Secondary Outcomes (11)

  • Peak oxygen uptake (VO2peak)

    1 year

  • Cardiovascular risk profile (ESC Score)

    16 weeks

  • Cardiovascular risk profile (ESC Score)

    1 year

  • Structural and functional cardiac changes

    16 weeks

  • Structural and functional cardiac changes

    1 year

  • +6 more secondary outcomes

Study Arms (2)

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.

Behavioral: PAI groupBehavioral: 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.

Behavioral: Usual care

Interventions

PAI groupBEHAVIORAL

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

PAI group
Usual careBEHAVIORAL

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

PAI groupUsual care

Eligibility Criteria

Age23 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participated in HUNT 3 and HUNT 4 Fitness Study
  • VO2peak in HUNT4 in the lowest sex- and age-specific tertile.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Circulation and Medical Imaging

Trondheim, Norway

Location

MeSH Terms

Conditions

Cardiovascular DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Øystein Risa, phd

    Norwegian University of Science and Technology

    STUDY DIRECTOR

  • Bjarne Martens Nes, phd

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 1, 2017

Study Start

October 1, 2017

Primary Completion

October 17, 2018

Study Completion

October 17, 2018

Last Updated

November 30, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

After the study ends all data from baseline and follow-up testing will be transferred to HUNT databank and made available for other researchers.

Shared Documents
STUDY PROTOCOL, ICF
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.

Locations

NO(1)