NCT02087774

Brief Summary

The investigators hypothesized that the addition of 6 minutes of exercise during the school day would increase physical fitness in elementary school students as demonstrated by longer distances run in 2 minutes and a decrease in heart rate at the end of the exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

August 15, 2014

Completed
Last Updated

August 15, 2014

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

March 12, 2014

Results QC Date

June 25, 2014

Last Update Submit

July 25, 2014

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline to After Intervention in 75 Foot Laps Completed in 2 Minutes

    Subjects run for 2 minutes around cone separated by 75ft. One lap was one 75 foot length completed. Difference in laps completed from baseline was taken.

    Baseline to 12 weeks later

  • Change From Baseline to After Intervention for After-Exercise Heart Rate

    Immediate cool-down, after-exercise heart rate was taken. Difference in heart rate from baseline measurements is reported

    Baseline to 12 weeks later

Study Arms (2)

Control School

NO INTERVENTION

Control School received no intervention.

6 minutes activity

EXPERIMENTAL

Implementation of 6 minutes of physical activity daily into the school day routine. Children can jog in place, do jumping jacks or dance.

Behavioral: 6 minutes activity

Interventions

Group added 6 minutes of physical activity daily during school day.

6 minutes activity

Eligibility Criteria

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

You may qualify if:

  • All students were invited to participate.

You may not qualify if:

  • Lack of parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marshall University

Huntington, West Virginia, 25755, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Non-randomized, controlled design. Majority of subject were caucasian, from Appalachian region.

Results Point of Contact

Title
Rebecca Hayes, M.D.
Organization
Marshall University

Study Officials

  • Rebecca H Hayes, M.D.

    Marshall University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 14, 2014

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 15, 2014

Results First Posted

August 15, 2014

Record last verified: 2014-07

Locations