Cardiovascular Risk FactorNCT03385447
The Effects of Faculty/Staff Exercise Program
A study testing Physical Activity in people with Cardiovascular Risk Factor and Sedentary Lifestyle, run by Kent State University.
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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Sedentary Lifestyle, Physical Activity
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 26 Jun 2013to 11 Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 21-65 years
- current faculty/staff member
- no contraindications to exercise
- sedentary prior to enrollment
Who cannot join
- age <21 years, >65 years
- non faculty/staff member
- contraindications to exercise
- regular exercise participation prior to enrollment
About this study
Official title: 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.
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.
- Being tested
- Physical Activity
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Participants underwent 12-weeks of exercise prescription aimed at the federal guidelines (3 days/week).
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | Participants were subjected to a 12-week exercise program targeting the federal physical activity guidelines. Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
Objectively measured height in meters using a standard clinical stadiometer.
Measured: Assessed once at baseline.
Weight
Objectively measured weight in kilograms using a standard clinical scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Change from baseline accelerometer-based physical activity 4-weeks, 8-weeks, and 12-weeks follow-up using 1-minute epochs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start26 Jun 2013
- Primary completion11 Oct 2013
- Study completion11 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duane Corbett, Kent State University
- Investigators
- Duane B Corbett, PhD, Study director, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385447
- Sponsor's protocol ID
- 13-329
- Status last verified
- Dec 2017
- First submitted
- 4 Dec 2017
- Last updated
- 28 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physiological and Cognitive Effects of Faculty/Staff Exercise Program in a University Setting
- ClinicalTrials.gov ID
- NCT03385447
- Acronym / sponsor ID
- 13-329
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Study start
- 26 Jun 2013 (actual)
- Primary completion
- 11 Oct 2013 (actual)
- Study completion
- 11 Oct 2013 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Behavioral: Physical ActivityParticipants were subjected to a 12-week exercise program targeting the federal physical activity guidelines. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 21-65 years
- current faculty/staff member
- no contraindications to exercise
- sedentary prior to enrollment
Key exclusion criteria (4 listed)
- age <21 years, >65 years
- non faculty/staff member
- contraindications to exercise
- regular exercise participation prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityParticipants underwent 12-weeks of exercise prescription aimed at the federal guidelines (3 days/week). | Behavioural | Physical Activity |
Primary outcome
Height
Time frame: Assessed once at baseline.
Objectively measured height in meters using a standard clinical stadiometer.
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Derived from this study: PubMed 29378632Corbett 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duane B Corbett, PhD study director
Kent State University
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Cardiovascular Risk Factor and Sedentary Lifestyle, run by Kent State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height (time frame: Assessed once at baseline.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03385447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.