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CompletedNCT03385447Updated Dec 28, 2017

The Effects of Faculty/Staff Exercise Program

An interventional study of Physical Activity in Cardiovascular Risk Factor, Sedentary Lifestyle and Physical Activity, sponsored by Kent State University. Completed. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-28.

Sponsored by Kent State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
21 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Cardiovascular Risk Factor
  • Sedentary Lifestyle
  • Physical Activity
03

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • age \<21 years, >65 years
  • non faculty/staff member
  • contraindications to exercise
  • regular exercise participation prior to enrollment
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Physical Activity

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

    Behavioral: Physical Activity

Interventions

  • BehavioralPhysical Activity

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

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What researchers measure

Primary outcomes

  1. Height

    Objectively measured height in meters using a standard clinical stadiometer.

    Time frame: Assessed once at baseline.

  2. Weight

    Objectively measured weight in kilograms using a standard clinical scale.

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

  3. Systolic Blood Pressure

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

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

  4. Diastolic Blood Pressure

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

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

  5. High-Density Lipoprotein

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

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

  6. Low-Density Lipoprotein

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

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

  7. Total Serum Cholesteral

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

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

  8. Impaired Fasting Glucose

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

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

Secondary outcomes

  1. Accelerometer-Based Physical Activity

    Assessment of accelerometer-based physical activity outcome measures (e.g., steps per day).

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

Other outcomes

  1. Sleep Quality (Pittsburgh Sleep Quality Index)

    The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.

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

  2. Depression (Depression, Anxiety, and Stress Scale-21)

    The depression, anxiety, and stress scale-21 (DASS-21) is a clinical assessment that measures the three related states of depression, anxiety and stress.

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

  3. Anxiety (Depression, Anxiety, and Stress Scale-21)

    The depression, anxiety, and stress scale-21 (DASS-21) is a clinical assessment that measures the three related states of depression, anxiety and stress.

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

  4. Stress (Depression, Anxiety, and Stress Scale-21)

    The depression, anxiety, and stress scale-21 (DASS-21) is a clinical assessment that measures the three related states of depression, anxiety and stress.

    Time frame: Change from baseline stress at 4-weeks, 8-weeks, and 12-weeks follow-up.

  5. Mood (Profile of Mood States)

    The Profile of Mood States (POMS) is a psychological rating scale used to assess transient, distinct mood states.

    Time frame: Change from baseline mood at 4-weeks, 8-weeks, and 12-weeks follow-up.

  6. Quality of Life (36-Item Short Form Survey)

    The 36-item short form survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures.

    Time frame: Change from baseline quality of life at 4-weeks, 8-weeks, and 12-weeks follow-up.

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Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 29378632 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03385447
Lead sponsor
Kent State University
Responsible party
Duane Corbett (Graduate Assistant, Kent State University) — Principal investigator
First posted
Dec 28, 2017
Start date
Jun 26, 2013
Primary completion
Oct 11, 2013
Completion
Oct 11, 2013
Last update
Dec 28, 2017

Study contacts

Duane B Corbett, PhD
study director · Kent State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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