- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03385447
The Effects of Faculty/Staff Exercise Program
The Physiological and Cognitive Effects of Faculty/Staff Exercise Program in a University Setting
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Physical Activity
Participants were subjected to a 12-week exercise program targeting the federal physical activity guidelines.
|
Participants underwent 12-weeks of exercise prescription aimed at the federal guidelines (3 days/week).
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What is the study measuring?
Primary Outcome Measures
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
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
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.
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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.
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Change from baseline quality of life at 4-weeks, 8-weeks, and 12-weeks follow-up.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Duane B Corbett, PhD, Kent State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 13-329
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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