NCT05077995

Brief Summary

The aim of this study will be to investigate the validity of a consumer available activity tracker (Polar M200) in free-living conditions to measure sedentary time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 25, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

October 1, 2021

Last Update Submit

May 23, 2022

Conditions

Healthy PersonsFitness Trackers

Outcome Measures

Primary Outcomes (1)

  • Sedentary time

    Sedentary time

    7 days

Secondary Outcomes (4)

  • Steps

    7 days

  • Sleeping time

    7 days

  • Standing time

    7 days

  • Walking time

    7 days

Study Arms (1)

Healthy adult group

EXPERIMENTAL

Sixty healthy adults, aged 18-65 years, will be included following written informed consent.

Device: Polar M200

Interventions

Polar M200DEVICE

Participants will have to wear the activity monitors (AP and Polar M200) for at least 7 days. Minutes spent in each activity type will be summed to a total day score. Participants will be instructed to do their regular daily life activities without limitation, but to note their main activity categories in an activity diary, with a main focus on cycling and participation in structured exercise.

Healthy adult group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Hasselt, Limburg, 3500, Belgium

Location

Study Officials

  • Bert Op 't Eijnde, Prof. dr.

    Hasselt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

October 1, 2021

First Posted

October 14, 2021

Study Start

July 25, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

May 24, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)