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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03385447
Other study ID # 13-329
Secondary ID
Status Completed
Phase N/A
First received December 4, 2017
Last updated December 20, 2017
Start date June 26, 2013
Est. completion date October 11, 2013

Study information

Verified date December 2017
Source Kent State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 11, 2013
Est. primary completion date October 11, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kent State University

Outcome

Type Measure Description Time frame Safety issue
Other 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. Change from baseline sleep quality at 4-weeks, 8-weeks, and 12-weeks follow-up.
Other 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. Change from baseline depression at 4-weeks, 8-weeks, and 12-weeks follow-up.
Other 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. Change from baseline anxiety at 4-weeks, 8-weeks, and 12-weeks follow-up.
Other 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. Change from baseline stress at 4-weeks, 8-weeks, and 12-weeks follow-up.
Other Mood (Profile of Mood States) 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.
Other 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. Change from baseline quality of life at 4-weeks, 8-weeks, and 12-weeks follow-up.
Primary Height Objectively measured height in meters using a standard clinical stadiometer. Assessed once at baseline.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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 Accelerometer-Based Physical Activity 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.
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