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Previous research suggests that prolonged sitting increases risk for cardiometabolic diseases and the risk factors associated with cardiometabolic diseases. However, no study to date has examined if a chronic intervention that breaks up prolonged sitting in a real-world environment results in a reduction in the metabolic risk factors associated with cardiometabolic diseases. Thus, the objective of this study is to examine the potential health benefits of breaking up sitting bouts throughout the workday using a small cycling device (DeskCycle) in office workers involved with jobs that require prolonged bouts of sitting. The investigators hypothesize that breaking up sitting will be associated with improvements in cardiometabolic disease risk factors. More specifically, the investigators hypothesize that breaking up sitting will decrease blood glucose during an oral glucose tolerance test (OGTT), increase cardiorespiratory fitness (VO2max), decrease blood pressure, decrease body fat, increase HDL cholesterol, and decrease LDL cholesterol, total cholesterol, and triglycerides.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cycling intervention | Experimental | Participants will use a small cycling device (DeskCycle) at their workstation for 15 minutes every hour that they are at work. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DeskCycle | Device | A small cycling ergometer that can fit under a desk at the workplace. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose | 2-h Post Oral Glucose Tolerance Test Blood Glucose | Measured after 4 weeks |
| Maximum Oxygen Consumption | Maximum oxygen consumption (VO2max) will be used to determine physical fitness | Measured after 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Measured after 4 weeks | |
| HDL Cholesterol | Measured after 4 weeks | |
| LDL Cholesterol |
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Inclusion Criteria:
Exclusion Criteria:
Females that are pregnant or breast-feeding.
Subjects must be free from any acute or chronic physical condition that would influence the outcome measures of the protocol. Examples include, but are not limited to advanced chronic disease states (chronic kidney, liver, heart, or lung disease), morbid obesity, emphysema, and an inability to use the legs for normal locomotion. Normality will be established on the basis of clinical history, physical exam, and vital signs. Any subject with a history of an uncontrolled metabolic disorder/disease or symptoms of active illness will be excluded from study. Any subject with a history of an uncontrolled metabolic disorder/disease such as diabetes (Type I or Type II) or symptoms of active illness will be excluded from study.
Medical/psychiatric/sleep disorders history: any clinically significant unstable medical or psychological condition within the last year (treated or untreated).
Drug use:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Boulder | Boulder | Colorado | 80309 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cycling Intervention | Participants will use a small cycling device (DeskCycle) at their workstation for 15 minutes every hour that they are at work. DeskCycle: A small cycling ergometer that can fit under a desk at the workplace. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cycling Intervention | Participants will use a small cycling device (DeskCycle) at their workstation for 15 minutes every hour that they are at work. DeskCycle: A small cycling ergometer that can fit under a desk at the workplace. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Glucose | 2-h Post Oral Glucose Tolerance Test Blood Glucose | Posted | Mean | Standard Deviation | mmol/L | Measured after 4 weeks |
|
|
2 years.
All-cause mortality was not assessed/collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cycling Intervention | Participants will use a small cycling device (DeskCycle) at their workstation for 15 minutes every hour that they are at work. DeskCycle: A small cycling ergometer that can fit under a desk at the workplace. |
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Participants were encouraged to cycle a set amount but this may not reflect how they would prefer to use the cycling device. In addition, the intervention was only 4 weeks long and more time may be needed to see improvements in the outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Peterman, PhD | University of Colorado Boulder | 303-735-0358 | james.peterman@colorado.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2017 | Oct 11, 2018 | Prot_SAP_000.pdf |
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| Measured after 4 weeks |
| Triglycerides | Measured after 4 weeks |
| Lean Mass | Measured after 4 weeks |
| Fat Mass | Measured after 4 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Maximum Oxygen Consumption (VO2max) | Mean | Standard Deviation | L/min |
|
| Blood Glucose | 2-h Post Oral Glucose Tolerance Test Blood Glucose | Mean | Standard Deviation | mmol/L |
|
| Work Sitting | Mean | Standard Deviation | hours |
|
| HDL Cholesterol | Mean | Standard Deviation | mmol/L |
|
| LDL Cholesterol | Mean | Standard Deviation | mmol/L |
|
| Triglycerides | Mean | Standard Deviation | mmol/L |
|
| Lean Mass | Mean | Standard Deviation | kg |
|
| Fat Mass | Mean | Standard Deviation | kg |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
|
| Primary | Maximum Oxygen Consumption | Maximum oxygen consumption (VO2max) will be used to determine physical fitness | Posted | Mean | Standard Deviation | L/min | Measured after 4 weeks |
|
|
|
| Secondary | Systolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | Measured after 4 weeks |
|
|
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| Secondary | HDL Cholesterol | Posted | Mean | Standard Deviation | mmol/L | Measured after 4 weeks |
|
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| Secondary | LDL Cholesterol | Posted | Mean | Standard Deviation | mmol/L | Measured after 4 weeks |
|
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| Secondary | Triglycerides | Posted | Mean | Standard Deviation | mmol/L | Measured after 4 weeks |
|
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| Secondary | Lean Mass | Posted | Mean | Standard Deviation | kg | Measured after 4 weeks |
|
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| Secondary | Fat Mass | Posted | Mean | Standard Deviation | kg | Measured after 4 weeks |
|
|
|
| 0 |
| 0 |
| 0 |
| 25 |
| 0 |
| 25 |
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