NCT02855541

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 13, 2018

Completed
Last Updated

November 13, 2018

Status Verified

November 1, 2018

Enrollment Period

10 months

First QC Date

July 29, 2016

Results QC Date

October 11, 2018

Last Update Submit

November 8, 2018

Conditions

Keywords

Blood GlucosePhysical FitnessBody CompositionLipids

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (6)

  • Systolic Blood Pressure

    Measured after 4 weeks

  • HDL Cholesterol

    Measured after 4 weeks

  • LDL Cholesterol

    Measured after 4 weeks

  • Triglycerides

    Measured after 4 weeks

  • Lean Mass

    Measured after 4 weeks

  • +1 more secondary outcomes

Study Arms (1)

Cycling intervention

EXPERIMENTAL

Participants will use a small cycling device (DeskCycle) at their workstation for 15 minutes every hour that they are at work.

Device: DeskCycle

Interventions

DeskCycleDEVICE

A small cycling ergometer that can fit under a desk at the workplace.

Cycling intervention

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

Limitations and Caveats

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.

Results Point of Contact

Title
James Peterman, PhD
Organization
University of Colorado Boulder

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 4, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 13, 2018

Results First Posted

November 13, 2018

Record last verified: 2018-11

Locations