Blood PressureNCT02855541
Health Effects of Increasing Muscle Activation While Sitting in Office Workers
A study testing DeskCycle in people with Blood Pressure, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- DeskCycle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both males and females
- Subjects will need to be 18-55 years old
- Subjects will need to be sitting at least 6 hours/day on 5 days/week
- Subjects will need to be exercising less than 5 hour/week
Who cannot join
- 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.
- Subjects will be excluded if they have a fasted blood glucose level >126 mg/dl or a systolic blood pressure >140 mmHg.
- Medical/psychiatric/sleep disorders history: any clinically significant unstable medical or psychological condition within the last year (treated or untreated).
- Drug use:
- Use of any medications, including over-the-counter and herbal products, that may affect metabolic function within 1 month prior to the study or need to use any of these medications at any time during the study (self-report by interview). Examples of potential medications that will exclude a subject include: beta-adrenergic blockers, sulfonylureas, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, meglitinides, and dipeptidyl peptidase IV inhibitors. Note, subjects may be tested at a later date.
- Use of any investigational drug within 1 month before the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
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.
- Conditions
- Blood Pressure
- Being tested
- DeskCycle
- Keywords
- Blood Glucose, Physical Fitness, Body Composition, Lipids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeskCycleDevice
A small cycling ergometer that can fit under a desk at the workplace.
| Study group | Role | What they receive |
|---|---|---|
| Cycling intervention | Experimental | Participants will use a small cycling device (DeskCycle) at their workstation for 15 minutes every hour that they are at work. Receives: Device: DeskCycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
2-h Post Oral Glucose Tolerance Test Blood Glucose
Measured: Measured after 4 weeks
Maximum Oxygen Consumption
Maximum oxygen consumption (VO2max) will be used to determine physical fitness
Measured: Measured after 4 weeks
Secondary outcomes (6)
Systolic Blood Pressure
Measured: Measured after 4 weeks
HDL Cholesterol
Measured: Measured after 4 weeks
LDL Cholesterol
Measured: Measured after 4 weeks
Triglycerides
Measured: Measured after 4 weeks
Lean Mass
Measured: Measured after 4 weeks
Fat Mass
Measured: Measured after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood PressureStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Peterman, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855541
- Sponsor's protocol ID
- UColoradoBoulder
- Status last verified
- Nov 2018
- First submitted
- 29 Jul 2016
- Last updated
- 13 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of Increasing Muscle Activation While Sitting in Office Workers
- ClinicalTrials.gov ID
- NCT02855541
- Acronym / sponsor ID
- UColoradoBoulder
- Conditions
- Blood Pressure
- Keywords
- Blood Glucose, Physical Fitness, Body Composition, Lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Posted 13 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cycling intervention | Experimental | Device: DeskCycleParticipants will use a small cycling device (DeskCycle) at their workstation for 15 minutes every hour that they are at work. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both males and females
- Subjects will need to be 18-55 years old
- Subjects will need to be sitting at least 6 hours/day on 5 days/week
- Subjects will need to be exercising less than 5 hour/week
Key exclusion criteria (7 listed)
- 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:
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 |
|---|---|---|
| DeskCycleA small cycling ergometer that can fit under a desk at the workplace. | Device | Cycling intervention |
Primary outcome
Blood Glucose
Time frame: Measured after 4 weeks
2-h Post Oral Glucose Tolerance Test Blood Glucose
Maximum Oxygen Consumption
Time frame: Measured after 4 weeks
Maximum oxygen consumption (VO2max) will be used to determine physical fitness
6 secondary outcomes
Systolic Blood Pressure
Time frame: Measured after 4 weeks
HDL Cholesterol
Time frame: Measured after 4 weeks
LDL Cholesterol
Time frame: Measured after 4 weeks
Triglycerides
Time frame: Measured after 4 weeks
Lean Mass
Time frame: Measured after 4 weeks
Fat Mass
Time frame: Measured after 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DeskCycle in people with Blood Pressure, run by University of Colorado, Boulder at 1 site in United States.
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 7 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 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 13 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blood Glucose (time frame: Measured after 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2018.