Healthy PersonsVAPONCT05077995
Validity and Reliability of the Polar M200 Activity Monitor
A study testing Polar M200 in people with Healthy Persons and Fitness Trackers, run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Persons, Fitness Trackers
- What is being tested?
- Polar M200
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Jul 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Persons, Fitness Trackers
- Being tested
- Polar M200
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adult group | Experimental | Sixty healthy adults, aged 18-65 years, will be included following written informed consent. Receives: Device: Polar M200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedentary time
Sedentary time
Measured: 7 days
Secondary outcomes (4)
Steps
Number of steps
Measured: 7 days
Sleeping time
Sleeping time
Measured: 7 days
Standing time
Standing time
Measured: 7 days
Walking time
Walking and running time
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start25 Jul 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PersonsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bert Op't Eijnde, Hasselt University
- Investigators
- Bert Op 't Eijnde, Prof. dr., Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077995
- Sponsor's protocol ID
- VAPO-UH
- Acronym
- VAPO
- Status last verified
- May 2022
- First submitted
- 1 Oct 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Polar M200 Activity Monitor to Measure Sedentary and Active Time
- ClinicalTrials.gov ID
- NCT05077995
- Acronym / sponsor ID
- VAPO / VAPO-UH
- Conditions
- Healthy Persons, Fitness Trackers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adult group | Experimental | Device: Polar M200Sixty healthy adults, aged 18-65 years, will be included following written informed consent. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (1 listed)
- /
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polar M200Participants 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. | Device | Healthy adult group |
Primary outcome
Sedentary time
Time frame: 7 days
Sedentary time
4 secondary outcomes
Steps
Time frame: 7 days
Sleeping time
Time frame: 7 days
Standing time
Time frame: 7 days
Walking time
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy Persons
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
RecruitingObservational study
Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy
Healthy Volunteer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bert Op 't Eijnde, Prof. dr. principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polar M200 in people with Healthy Persons and Fitness Trackers, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedentary time (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.