NCT03385447

Brief Summary

This study focuses on analyzing the data collected from participants in the Faculty/Staff Exercise Program to determine the success and quantifying the results of the program. The investigators are interested in the effectiveness of this program on multiple levels, individual and group, as it is the first of its kind - an exercise program targeting the faculty and staff at a university.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

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

June 26, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2013

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
Last Updated

December 28, 2017

Status Verified

December 1, 2017

Enrollment Period

4 months

First QC Date

December 4, 2017

Last Update Submit

December 20, 2017

Conditions

Outcome Measures

Primary Outcomes (8)

  • Height

    Objectively measured height in meters using a standard clinical stadiometer.

    Assessed once at baseline.

  • Weight

    Objectively measured weight in kilograms using a standard clinical scale.

    Change from baseline weight at 4-weeks, 8-weeks, and 12-weeks follow-up.

  • Systolic Blood Pressure

    Objectively measured systolic blood pressure in millimeters of Mercury using a standard Mercury sphygmomanometer.

    Change from baseline systolic blood pressure at 4-weeks, 8-weeks, and 12-weeks follow-up.

  • Diastolic Blood Pressure

    Objectively measured diastolic blood pressure in millimeters of Mercury using a standard Mercury sphygmomanometer.

    Change from baseline diastolic blood pressure at 4-weeks, 8-weeks, and 12-weeks follow-up.

  • High-Density Lipoprotein

    Objectively measured high-density lipoprotein in milligrams per deciliter using a standard assay kit.

    Change from baseline high-density lipoprotein at 4-weeks, 8-weeks, and 12-weeks follow-up.

  • Low-Density Lipoprotein

    Objectively measured low-density lipoprotein in milligrams per deciliter using a standard assay kit.

    Change from baseline low-density lipoprotein at 4-weeks, 8-weeks, and 12-weeks follow-up.

  • Total Serum Cholesteral

    Objectively measured total serum cholesterol in milligrams per deciliter using a standard assay kit.

    Change from baseline total serum cholesterol at 4-weeks, 8-weeks, and 12-weeks follow-up.

  • Impaired Fasting Glucose

    Objectively measured impaired fasting glucose in milligrams per deciliter using a standard assay kit.

    Change from baseline impaired fasting glucose at 4-weeks, 8-weeks, and 12-weeks follow-up.

Secondary Outcomes (1)

  • Accelerometer-Based Physical Activity

    Change from baseline accelerometer-based physical activity 4-weeks, 8-weeks, and 12-weeks follow-up using 1-minute epochs.

Other Outcomes (6)

  • Sleep Quality (Pittsburgh Sleep Quality Index)

    Change from baseline sleep quality at 4-weeks, 8-weeks, and 12-weeks follow-up.

  • Depression (Depression, Anxiety, and Stress Scale-21)

    Change from baseline depression at 4-weeks, 8-weeks, and 12-weeks follow-up.

  • Anxiety (Depression, Anxiety, and Stress Scale-21)

    Change from baseline anxiety at 4-weeks, 8-weeks, and 12-weeks follow-up.

  • +3 more other outcomes

Study Arms (1)

Physical Activity

EXPERIMENTAL

Participants were subjected to a 12-week exercise program targeting the federal physical activity guidelines.

Behavioral: Physical Activity

Interventions

Participants underwent 12-weeks of exercise prescription aimed at the federal guidelines (3 days/week).

Physical Activity

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 21-65 years
  • current faculty/staff member
  • no contraindications to exercise
  • sedentary prior to enrollment

You may not qualify if:

  • age \<21 years, \>65 years
  • non faculty/staff member
  • contraindications to exercise
  • regular exercise participation prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Corbett DB, Fennell C, Peroutky K, Kingsley JD, Glickman EL. The effects of a 12-week worksite physical activity intervention on anthropometric indices, blood pressure indices, and plasma biomarkers of cardiovascular disease risk among university employees. BMC Res Notes. 2018 Jan 29;11(1):80. doi: 10.1186/s13104-018-3151-x.

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Duane B Corbett, PhD

    Kent State University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Assistant

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 28, 2017

Study Start

June 26, 2013

Primary Completion

October 11, 2013

Study Completion

October 11, 2013

Last Updated

December 28, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share