The Effects of Faculty/Staff Exercise Program

December 20, 2017 updated by: Duane Corbett, Kent State University

The Physiological and Cognitive Effects of Faculty/Staff Exercise Program in a University Setting

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.

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

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. Participants were regular attendees in either a 6am or 12pm exercise program session. Data included both measures of physical health as well as cognitive health. Measures of physical health included the assessment of body fat using the skin-fold method of analysis (3-site). Cholesterol was measured via blood draw analysis. This was done at the Kent State University Exercise Physiology Laboratory by certified research staff. A 6 minute walk test was completed to measure aerobic capacity. Flexibility was assessed via the sit-and-reach test while anaerobic strength and endurance were assessed using sit-up and curl-up tests. Assessment of balance was done using a Biodex Balance System.

Assessments of cognitive health included several questionnaires that asked questions related to sleep habits, stress levels, and mood. In addition, each participant was given a MOVband to track physical activity. The device was worn during waking hours for all days of participation.The data from the MOVband was auto-uploaded to a computer program for tracking so that no manual entry was necessary.

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.
50

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

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

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group 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: Physical Activity
Participants were subjected to a 12-week exercise program targeting the federal physical activity guidelines.
Behavioral: Physical Activity
Participants underwent 12-weeks of exercise prescription aimed at the federal guidelines (3 days/week).

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
Height
Time Frame: Assessed once at baseline.
Objectively measured height in meters using a standard clinical stadiometer.
Assessed once at baseline.
Weight
Time Frame: Change from baseline weight at 4-weeks, 8-weeks, and 12-weeks follow-up.
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
Time Frame: Change from baseline systolic blood pressure at 4-weeks, 8-weeks, and 12-weeks follow-up.
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
Time Frame: Change from baseline diastolic blood pressure at 4-weeks, 8-weeks, and 12-weeks follow-up.
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
Time Frame: Change from baseline high-density lipoprotein at 4-weeks, 8-weeks, and 12-weeks follow-up.
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
Time Frame: Change from baseline low-density lipoprotein at 4-weeks, 8-weeks, and 12-weeks follow-up.
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
Time Frame: Change from baseline total serum cholesterol at 4-weeks, 8-weeks, and 12-weeks follow-up.
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
Time Frame: Change from baseline impaired fasting glucose at 4-weeks, 8-weeks, and 12-weeks follow-up.
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 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
Accelerometer-Based Physical Activity
Time Frame: Change from baseline accelerometer-based physical activity 4-weeks, 8-weeks, and 12-weeks follow-up using 1-minute epochs.
Assessment of accelerometer-based physical activity outcome measures (e.g., steps per day).
Change from baseline accelerometer-based physical activity 4-weeks, 8-weeks, and 12-weeks follow-up using 1-minute epochs.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep Quality (Pittsburgh Sleep Quality Index)
Time Frame: Change from baseline sleep quality at 4-weeks, 8-weeks, and 12-weeks follow-up.
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
Change from baseline sleep quality at 4-weeks, 8-weeks, and 12-weeks follow-up.
Depression (Depression, Anxiety, and Stress Scale-21)
Time Frame: Change from baseline depression at 4-weeks, 8-weeks, and 12-weeks follow-up.
The depression, anxiety, and stress scale-21 (DASS-21) is a clinical assessment that measures the three related states of depression, anxiety and stress.
Change from baseline depression at 4-weeks, 8-weeks, and 12-weeks follow-up.
Anxiety (Depression, Anxiety, and Stress Scale-21)
Time Frame: Change from baseline anxiety at 4-weeks, 8-weeks, and 12-weeks follow-up.
The depression, anxiety, and stress scale-21 (DASS-21) is a clinical assessment that measures the three related states of depression, anxiety and stress.
Change from baseline anxiety at 4-weeks, 8-weeks, and 12-weeks follow-up.
Stress (Depression, Anxiety, and Stress Scale-21)
Time Frame: Change from baseline stress at 4-weeks, 8-weeks, and 12-weeks follow-up.
The depression, anxiety, and stress scale-21 (DASS-21) is a clinical assessment that measures the three related states of depression, anxiety and stress.
Change from baseline stress at 4-weeks, 8-weeks, and 12-weeks follow-up.
Mood (Profile of Mood States)
Time Frame: Change from baseline mood at 4-weeks, 8-weeks, and 12-weeks follow-up.
The Profile of Mood States (POMS) is a psychological rating scale used to assess transient, distinct mood states.
Change from baseline mood at 4-weeks, 8-weeks, and 12-weeks follow-up.
Quality of Life (36-Item Short Form Survey)
Time Frame: Change from baseline quality of life at 4-weeks, 8-weeks, and 12-weeks follow-up.
The 36-item short form survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures.
Change from baseline quality of life at 4-weeks, 8-weeks, and 12-weeks follow-up.

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.
Kent State University

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.
  • Study Director: Duane B Corbett, PhD, Kent State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
June 26, 2013

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.
October 11, 2013

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.
October 11, 2013

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).
December 4, 2017

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.
December 20, 2017

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.
December 28, 2017

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.
December 28, 2017

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.
December 20, 2017

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.
December 1, 2017

More Information

Terms related to this study

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.
  • 13-329

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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