NCT02927275

Brief Summary

The purpose of this study is to evaluate the effect of low-intensity exercise on cognitive functioning during activity. Evaluation was accomplished by having participants perform standardized cognitive tests while in three forms of low-intensity exercise and then comparing results to performance when sitting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 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

Study Start

First participant enrolled

April 1, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

3.4 years

First QC Date

October 1, 2016

Last Update Submit

October 5, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognitive Testing Performance

    Scores generated from cognitive testing

    Starting in April 2012, participant enrollment was open for 41 months with data collection occurring immediately at the time of testing with no need for follow-up outcome measurements.

Study Arms (4)

Standing Modality

EXPERIMENTAL

Performance on computerized cognitive tests while standing at a desk. Experimental: Standing Modality

Behavioral: Experimental: Standing Modality

Biking Modality

EXPERIMENTAL

Performance on computerized cognitive tests while biking at user's preferred speed on stationary bicycle. Experimental: Biking Modality

Behavioral: Experimental: Biking Modality

Walking Modality

EXPERIMENTAL

Performance on computerized cognitive tests while walking at 1mph. Experimental: Walking Modality

Behavioral: Experimental: Walking Modality

Seated Modality

OTHER

Performance on computerized cognitive tests while sitting. No Intervention: Seated Modality

Behavioral: No Intervention: Seated Modality

Interventions

Cognitive performance when standing

Standing Modality

Cognitive performance when biking slowly

Biking Modality

Cognitive performance when walking at 1mph

Walking Modality

Cognitive performance when sitting.

Seated Modality

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Student at Baylor College of Medicine
  • Able to perform low-intensity exercise

You may not qualify if:

  • Not a student at Baylor College of Medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine-Department of Obstetrics & Gynecology

Houston, Texas, 77030, United States

Location

Related Publications (38)

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Study Officials

  • Cecilia T Valdes, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate Professor-Obstetrics & Gynecology

Study Record Dates

First Submitted

October 1, 2016

First Posted

October 7, 2016

Study Start

April 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 7, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Individual performance on testing rounds was incorporated into cumulative statistical analysis and will not be made public.

Locations