NCT04050332

Brief Summary

There are two main aims for this study:

  1. 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. 2.assess the association of a 4-min bout of self-paced stair walking with changes in blood pressure, mood, and perceived exertion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 16, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2019

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

29 days

First QC Date

August 2, 2019

Last Update Submit

November 19, 2019

Conditions

Keywords

Radio Frequency Identification Device

Outcome Measures

Primary Outcomes (3)

  • Stair walking duration

    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

    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

    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 Outcomes (6)

  • Blood Pressure

    Before stair walking and 2-minutes and 5-minutes post stair walking

  • Borg's Rating of Perceived Exertion

    Immediately after stair walking

  • Mental Energy

    Before and immediately after stair walking

  • Mental Fatigue

    Before and immediately after stair walking

  • Physical Energy

    Before and immediately after stair walking

  • +1 more secondary outcomes

Study Arms (2)

Stair Walking

EXPERIMENTAL

Participants in this arm will engage in four minutes of stair walking while being tracked by radio frequency identification equipment.

Behavioral: Stair Walking

Control

NO INTERVENTION

Participants in this arm will stand in the stairwell for four minutes while being tracked by radio frequency identification equipment.

Interventions

Stair WalkingBEHAVIORAL

Walking up and down stairs for four minutes at a comfortable pace

Stair Walking

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • in desired age range

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramsey Center

Athens, Georgia, 30602, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jennifer L Gay, PhD

    University of Georgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 8, 2019

Study Start

October 16, 2019

Primary Completion

November 14, 2019

Study Completion

November 14, 2019

Last Updated

November 20, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Upon publication of the primary and secondary outcomes
Access Criteria
Data access requests will be reviewed by the study team. Requestors will be required to sign a Data Access Agreement.

Locations