Sedentary LifestyleNCT03236597
Assessing the Effects Of Treadmill On LPA, Sitting Time, and Cardiovascular Risk
A study testing Treadmill desk in people with Sedentary Lifestyle and Risk Factor, Cardiovascular, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to: 1. Evaluate the relative efficacy of a treadmill desk intervention on light physical activity and sitting behaviors at work over four weeks; 2. Evaluate the relative efficacy of a treadmill desk intervention on the cardiovascular risk profiles (blood pressure, body weight, body fat… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Risk Factor, Cardiovascular
- What is being tested?
- Treadmill desk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2018to 8 Dec 2019
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not currently pregnant or planning to become pregnant during the 11 week study period.
- Able to read and write in English.
- No current use of a sit/stand or treadmill desk.
- Work that is done in a predominately stationary position.
- Working at UMN West Bank Office Building at least 30 hours per week.
- Not currently meeting physical activity guidelines.
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- No balance issues (i.e. healthy vestibular system)
- No contraindications to standing or walking
- Weight stable for the past 12 months.
- Taking no more than 3 prescription drugs, with stable dosage, over the past 12 months
- Answer of no to all Physical Activity Readiness-Questionnaire (PAR-Q) questions
Who cannot join
- Currently pregnant or actively trying to become pregnant during the 14 week study period.
- Unable to read and write in English.
- Working less than 30 hours per week.
- Currently meeting physical activity guidelines.
- Non-sedentary job.
- Current use of treadmill desk
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- Any reported balance problems
- Anyone with contraindications to standing or walking
- Weight fluctuations of more than +/- 10% of their body weight in the past year
- Individuals taking more than 4 prescription drugs and/or unstable dosage of medications over the past 12 months if taking 3 or less.
- Answer of yes to any PAR-Q questions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota West Bank Office Building
Minneapolis, Minnesota, 55454
About this study
Official title: Assessing the Effects Of Treadmill On Light Physical Activity, Sitting Time, And Cardiovascular Risk
The purpose of this study is to:
- Evaluate the relative efficacy of a treadmill desk intervention on light physical activity and sitting behaviors at work over four weeks;
- Evaluate the relative efficacy of a treadmill desk intervention on the cardiovascular risk profiles (blood pressure, body weight, body fat percentage) over a four-week period.
Read the detailed description
American workers spend 70-80% of their time at work sitting at a desk, working on a computer, talking on a telephone, and sitting in meetings. Traditional approaches to increase MVPA in the workplace may not be sustainable as they require deliberate and dedicated time away from work, and may be perceived as harmful to productivity. Sedentary behavior interventions, in contrast, do not interfere with daily tasks and productivity and require small but cumulative changes in posture and LPA throughout the workday.
Sedentary behavior interventions in the worksite, including those conducted by our team, have shown promising effects. Studies that have used multi-level approaches targeting individual, social, and environmental factors have been most effective. The most robust environmental support has been the use of sit-stand workstations, providing distinct opportunities for workers to reduce sitting while maintaining productivity. However, treadmill desks may provide an even greater opportunity to both reduce sitting and increase LPA during the workday. Thus, a pilot study is required to test the efficacy of this approach to reduce sitting and increase LPA in the workplace.
- Conditions
- Sedentary Lifestyle, Risk Factor, Cardiovascular
- Being tested
- Treadmill desk
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill deskOther
Also called ActiveStation Treadmill desks
A standing height desk with a treadmill attached.
| Study group | Role | What they receive |
|---|---|---|
| Usual Desk | No intervention | participants will work at their usual desk for four weeks. |
| Treadmill desk | Experimental | Participants will be asked to use a treadmill desk for a minimum of 30 minutes per day for four weeks (Participants will sign up for a total of 30 minutes each day). Additional time may be spent on the treadmill, time permitting (two treadmills will be available to up to 10 people over the four week period). Receives: Other: Treadmill desk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent sitting
The change in time spent sitting as measured by the ActivPAL, from baseline to the final week of each intervention condition
Measured: 7-days
Time spent standing
The change in time spent standing as measured by the ActivPAL, from baseline to the final week of each intervention condition
Measured: 7-days
Time spent moving
The change in time spent moving as measured by the ActivPAL, from baseline to the final week of each intervention condition
Measured: 7-days
Secondary outcomes (3)
Cardiovascular risk: Blood pressure
The change in the cardiovascular risk, as measured via blood pressure from baseline to the final week of each condition.
Measured: 7-days
Cardiovascular risk: Body weight
The change in the cardiovascular risk, as measured via body weight from baseline to the final week of each condition.
Measured: 7-days
Cardiovascular risk: Percent body fat
The change in the cardiovascular risk, as measured via percent body fat from baseline to the final week of each condition.
Measured: 7-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start5 Oct 2018
- Primary completion7 Dec 2019
- Study completion8 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A within-person, cross-over design will be used. Fifteen participants will take part in two conditions: 1) the treadmill desk: this intervention will ask participants to use a treadmill desk for a minimum of 30min per day for four weeks; and 2) the usual desk condition: participants will use their current workstation, as is, for four weeks. Participants will be randomly assigned to their initial intervention condition after baseline measures have been collected. In addition to the two condition months, there will be a one-week baseline period (to collected information on habitual activity level at work).
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236597
- Sponsor's protocol ID
- STUDY000000866
- Status last verified
- Jan 2020
- First submitted
- 27 Jul 2017
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified IPD for all primary and secondary outcome measures will be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects Of Treadmill On Light Physical Activity, Sitting Time, And Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT03236597
- Acronym / sponsor ID
- STUDY000000866
- Conditions
- Sedentary Lifestyle, Risk Factor, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 7 Dec 2019 (actual)
- Study completion
- 8 Dec 2019 (actual)
- First posted
- 2 Aug 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.
The purpose of this study is to:
- Evaluate the relative efficacy of a treadmill desk intervention on light physical activity and sitting behaviors at work over four weeks;
- Evaluate the relative efficacy of a treadmill desk intervention on the cardiovascular risk profiles (blood pressure, body weight, body fat percentage) over a four-week period.
Detailed description
American workers spend 70-80% of their time at work sitting at a desk, working on a computer, talking on a telephone, and sitting in meetings. Traditional approaches to increase MVPA in the workplace may not be sustainable as they require deliberate and dedicated time away from work, and may be perceived as harmful to productivity. Sedentary behavior interventions, in contrast, do not interfere with daily tasks and productivity and require small but cumulative changes in posture and LPA throughout the workday.
Sedentary behavior interventions in the worksite, including those conducted by our team, have shown promising effects. Studies that have used multi-level approaches targeting individual, social, and environmental factors have been most effective. The most robust environmental support has been the use of sit-stand workstations, providing distinct opportunities for workers to reduce sitting while maintaining productivity. However, treadmill desks may provide an even greater opportunity to both reduce sitting and increase LPA during the workday. Thus, a pilot study is required to test the efficacy of this approach to reduce sitting and increase LPA in the workplace.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A within-person, cross-over design will be used. Fifteen participants will take part in two conditions: 1) the treadmill desk: this intervention will ask participants to use a treadmill desk for a minimum of 30min per day for four weeks; and 2) the usual desk condition: participants will use their current workstation, as is, for four weeks. Participants will be randomly assigned to their initial intervention condition after baseline measures have been collected. In addition to the two condition months, there will be a one-week baseline period (to collected information on habitual activity level at work).
| Arm | Type | Receives |
|---|---|---|
| Usual Desk | No intervention | –participants will work at their usual desk for four weeks. |
| Treadmill desk | Experimental | Other: Treadmill deskParticipants will be asked to use a treadmill desk for a minimum of 30 minutes per day for four weeks (Participants will sign up for a total of 30 minutes each day). Additional time may be spent on the treadmill, time permitting (two treadmills will be available to up to 10 people over the four week period). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Not currently pregnant or planning to become pregnant during the 11 week study period.
- Able to read and write in English.
- No current use of a sit/stand or treadmill desk.
- Work that is done in a predominately stationary position.
- Working at UMN West Bank Office Building at least 30 hours per week.
Key exclusion criteria (11 listed)
- Currently pregnant or actively trying to become pregnant during the 14 week study period.
- Unable to read and write in English.
- Working less than 30 hours per week.
- Currently meeting physical activity guidelines.
- Non-sedentary job.
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 |
|---|---|---|
| Treadmill deskAlso: ActiveStation Treadmill desksA standing height desk with a treadmill attached. | Other | Treadmill desk |
Primary outcome
Time spent sitting
Time frame: 7-days
The change in time spent sitting as measured by the ActivPAL, from baseline to the final week of each intervention condition
Time spent standing
Time frame: 7-days
The change in time spent standing as measured by the ActivPAL, from baseline to the final week of each intervention condition
Time spent moving
Time frame: 7-days
The change in time spent moving as measured by the ActivPAL, from baseline to the final week of each intervention condition
3 secondary outcomes
Cardiovascular risk: Blood pressure
Time frame: 7-days
Cardiovascular risk: Body weight
Time frame: 7-days
Cardiovascular risk: Percent body fat
Time frame: 7-days
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 7 Jan 2020.
- Individual participant dataSharing planned: Yes. Deidentified IPD for all primary and secondary outcome measures will be made available upon request.
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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 Treadmill desk in people with Sedentary Lifestyle and Risk Factor, Cardiovascular, run by University of Minnesota 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 11 inclusion and 11 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 7 Jan 2020. 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?
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?
Time spent sitting (time frame: 7-days). The study lists 3 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 7 Jan 2020.