- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05077995
Validity and Reliability of the Polar M200 Activity Monitor (VAPO)
May 23, 2022 updated by: Bert Op't Eijnde, Hasselt University
Validity and Reliability of the Polar M200 Activity Monitor to Measure Sedentary and Active Time
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Limburg
-
Hasselt, Limburg, Belgium, 3500
- Hasselt University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adults
Exclusion Criteria:
- /
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy adult group
Sixty healthy adults, aged 18-65 years, will be included following written informed consent.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sedentary time
Time Frame: 7 days
|
Sedentary time
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Steps
Time Frame: 7 days
|
Number of steps
|
7 days
|
Sleeping time
Time Frame: 7 days
|
Sleeping time
|
7 days
|
Standing time
Time Frame: 7 days
|
Standing time
|
7 days
|
Walking time
Time Frame: 7 days
|
Walking and running time
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bert Op 't Eijnde, Prof. dr., Hasselt University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2021
Primary Completion (Actual)
May 1, 2022
Study Completion (Actual)
May 1, 2022
Study Registration Dates
First Submitted
October 1, 2021
First Submitted That Met QC Criteria
October 1, 2021
First Posted (Actual)
October 14, 2021
Study Record Updates
Last Update Posted (Actual)
May 24, 2022
Last Update Submitted That Met QC Criteria
May 23, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- VAPO-UH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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