Can RFID Technology Capture Stair Walking

November 19, 2019 updated by: Jennifer Gay, University of Georgia

Can RFID Technology Capture Stair Walking: A Pilot Study

There are two main aims for this study:

  1. conduct a proof-of-concept study illustrating how radio-frequency identification technology can be used to document the timestamps and duration of stair walking (ascending and descending stairs), and detect if an individual is stationary in the stairwell.
  2. assess the association of a 4-min bout of self-paced stair walking with changes in blood pressure, mood, and perceived exertion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective, passive methods for measuring physical activity participation can minimize error associated with self-report bias and cognitive processing. This study will test the utility of radio frequency identification (RFID) for the measurement of stair walking within buildings. RFID readers will be placed at stairwell entrances on each floor. Participants will wear a RFID tag. As the participant walks past the different readers going up and down the stairs, the reader will log the date and time. The frequency and duration of time in the stairwell can be calculated, as can an estimated speed.

There are known effects for blood pressure (hypotensive) and moodafter exercise. However, few studies have assessed this effect for short bouts (<10 minutes) of exercise. Participants will have their pre- and post-stair walking blood pressure measured to determine the hypotensive and mood enhancing effects of four minutes of stair walking at a comfortable pace. Participants also will rate the exertion level of four minutes of stair walking at a self-selected pace.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Georgia
      • Athens, Georgia, United States, 30602
        • Ramsey Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • in desired age range

Exclusion Criteria:

  • Unable to or uncomfortable climbing stairs
  • Not cleared for exercise using the Physical Activity Readiness Questionnaire (PAR-Q+)

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stair Walking
Participants in this arm will engage in four minutes of stair walking while being tracked by radio frequency identification equipment.
Behavioral: Stair Walking
Walking up and down stairs for four minutes at a comfortable pace
No Intervention: Control
Participants in this arm will stand in the stairwell for four minutes while being tracked by radio frequency identification equipment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stair walking duration
Time Frame: Calculated after the completion of the 4-minute stair walking episode
Duration, in seconds, of stair walking as tracked by the RFID equipment
Calculated after the completion of the 4-minute stair walking episode
Stair walking distance
Time Frame: Calculated after the completion of the 4-minute stair walking episode
Distance, in number of stairs climbed, as tracked by the RFID equipment
Calculated after the completion of the 4-minute stair walking episode
Stair walking speed
Time Frame: Calculated after the completion of the 4-minute stair walking episode
Speed of stair walking, in stairs per second based on duration and distance, as tracked by the RFID equipment
Calculated after the completion of the 4-minute stair walking episode

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: Before stair walking and 2-minutes and 5-minutes post stair walking
Systolic and diastolic blood pressure
Before stair walking and 2-minutes and 5-minutes post stair walking
Borg's Rating of Perceived Exertion
Time Frame: Immediately after stair walking
A one-item measure of a participant's perceived physical effort during an activity. Responses range from 6 (no exertion) to 20 (maximal exertion), where higher scores indicate a greater perceived exertion.
Immediately after stair walking
Mental Energy
Time Frame: Before and immediately after stair walking
Measured by self-report using the State Energy and Fatigue Scale. There are 3 items, scored using a number line from 0 to 100, that are summed to generate a score, where higher scores indicate greater mental energy.
Before and immediately after stair walking
Mental Fatigue
Time Frame: Before and immediately after stair walking
Measured by self-report using the State Energy and Fatigue Scale. There are 3 items, scored using a number line from 0 to 100, that are summed to generate a score, where higher scores indicate greater mental fatigue.
Before and immediately after stair walking
Physical Energy
Time Frame: Before and immediately after stair walking
Measured by self-report using the State Energy and Fatigue Scale. There are 3 items, scored using a number line from 0 to 100, that are summed to generate a score, where higher scores indicate greater physical energy.
Before and immediately after stair walking
Physical Fatigue
Time Frame: Before and immediately after stair walking
Measured by self-report using the State Energy and Fatigue Scale. There are 3 items, scored using a number line from 0 to 100, that are summed to generate a score, where higher scores indicate greater physical fatigue.
Before and immediately after stair walking

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Georgia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer L Gay, PhD, University of Georgia

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 14, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PROJECT00000674

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified, data may be shared for primary and secondary outcomes.

IPD Sharing Time Frame

Upon publication of the primary and secondary outcomes

IPD Sharing Access Criteria

Data access requests will be reviewed by the study team. Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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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