Validity and Reliability of the Polar M200 Activity Monitor | NCT05077995

Studies
Validity and Reliability of the Polar M200 Activity Monitor

NCT05077995

Sponsor

Hasselt University

Status

Completed

Last Update Posted

May 24, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Healthy Persons
Fitness Trackers

Interventions

Polar M200

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2021Actual

Primary Completion Date

May 1, 2022Actual

Completion Date

May 1, 2022Actual

First Submitted Date

Oct 1, 2021

First Submission Date that Met QC Criteria

Oct 1, 2021

First Posted Date

Oct 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2022

Last Update Posted Date

May 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The aim of the present study is to evaluate the validity from a commercially available wearable Polar device. Consumer-based activity trackers are generally cheaper, designed for long-term wear and are less intrusive. Potentially, consumer-based activity trackers can be used for research purposes, but high-quality validation studies are needed. The aims of this study will be to assess validity of sedentary outcome measures of a Polar device during free-living conditions in comparison with the ActivPAL3TM activity monitor (AP; PAL Technologies Ltd, Glasgow, UK), which is considered the gold standard to measure sedentary time in free-living conditions.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy adult group	Experimental	Sixty healthy adults, aged 18-65 years, will be included following written informed consent.	Device: Polar M200

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polar M200	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sedentary time	Sedentary time	7 days

Secondary Outcomes

Measure	Description	Time Frame
Steps	Number of steps	7 days
Sleeping time	Sleeping time	7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adults

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bert Op 't Eijnde, Prof. dr.	Hasselt University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hasselt University		Hasselt	Limburg	3500	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided