Sedentary LifestyleNCT02342301
Cardiometabolic Response to Sit-stand Workstations.
A study testing Standing Desk and Traditional Desk in people with Sedentary Lifestyle, run by University of Prince Edward Island at 1 site in Canada.
Trial summary
We aim to determine if changing a person's workstation from a traditional seated desk to a height adjustable "standing desk" for a period of approximately 3 months is associated with alterations in traditional measures of cardiometabolic risk. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Standing Desk and Traditional Desk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Sep 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male and female participants
- 18 years of age and older
- work in an office-based setting.
- abdominally obese, defined as a waist circumference ≥ 88 cm for women, and 102 cm for men.
Who cannot join
- glucose lowering medication
- inability to stand or walk
Trial locations and contacts
1 site in 1 country.
Canada1 site
Human Performance and Health Research Lab, University of Prince Edward Island
Charlottetown, Prince Edward Island, C1A4P3
About this study
We aim to determine if changing a person's workstation from a traditional seated desk to a height adjustable "standing desk" for a period of approximately 3 months is associated with alterations in traditional measures of cardiometabolic risk.
Read the detailed description
The present study will include 24 male and female participants 18 years of age and older who work in an office-based setting. To be included participants must be abdominally obese, defined as a waist circumference ≥ 88 cm for women, and 102 cm for men. All potential participants will be asked to come to the Human Performance Laboratory at University of Prince Edward Island and will be given an opportunity to ask questions about the study, and to read and sign the informed consent form. Once this has taken place, participants will have their waist circumference measured in order to determine whether they meet the above criteria. If not, the individual will be thanked for their time and told that they are not eligible to participate in the current study.
Lab Day 1 (baseline)
Once screening is complete, participants will have glycosylated hemoglobin checked via a simple finger prick and point-of-care analysis of a single drop of blood. (Funding dependent, a second drop of blood may be used to analyze the participant's blood lipid profile- as would be done at a typical doctor's office visit). Next we will measure the participants' resting metabolic rate, by having them lay on a hospital bed while we analyze the oxygen and carbon dioxide concentrations of the air they exhale. This will inform us as to the participant's baseline caloric needs. Blood pressure, height, weight, waist circumference and body composition will be determined following resting metabolic rate, prior to the determination of aerobic fitness using a sub-maximal exercise protocol (see below).
Augmentation Index:
Arterial stiffness will be determined using a Sphygmocor pulse wave applanation tonomoter (Atcor Medical). This device measures arterial pulse waves non-invasively through the skin at the wrist. We will use this same device to analyze the shape of the pulse wave, which will give us information about reflected pulse waves (and thus the stiffness of the arterial tree). The measure of arterial stiffness is non-invasive and pain-free and is taken using a pen-like tool pressed against the participant's skin to detect his or her pulse.
Prior to departing the lab, participants will be instructed on the use of an accelerometer-based activity monitor (20 min), which they will wear for 1 week prior to the desk intervention. During the activity monitor collection week, participants will also be instructed to wear a heart rate belt (non-invasive chest strap) for one day during working hours only (at least 4 hours of data collection) which will be analyzed after the strap is returned to the lab. Participants will then answer an online questionnaire about his/her current physical activity and sedentary behaviors. https://docs.google.com/forms/d/1fjz5ua47KzcdnhCAN7wCDGNbvy-tKSGgZKGGhIKSqQg/viewform?usp=mail_form_link . A similar questionnaire will be used for post- intervention follow-up with the tenses changed and questions about "anticipated" desk use altered to report on "actual" use (participants in the control group will be asked to answer "not applicable" for any questions related to standing desk use on the follow-up questionnaire).
Total participation Time (1.5 hr)
Once the baseline testing session is complete, participants will be randomly allocated to intervention or control groups (12 participants per group). Participants in the intervention group will be asked to complete the below intervention, while those in the control group will be asked to maintain their current lifestyle and office workstation throughout the study.
Intervention- the participant will be given a stand-up desk and asked to use it in place of their normal desk at work. Participants will again be given the activity and HR monitors to wear during the first and last 2 weeks of desk use.
Lab day 2 (post) - all measures from lab day 1 will be repeated as described above.
Aerobic Fitness- Aerobic fitness will be determined using a treadmill-based graded exercise test with analysis of expired gases. The test will consist of 2-3 increasingly more challenging stages of walking/running (through the addition of speed or incline) at a submaximal intensity. The heart rate and oxygen consumption data collected will be used to extrapolate the data to estimate maximal values. All aerobic fitness tests will be administered under the supervision of a Canadian Society for Exercise Physiology Certified Exercise Physiologist. Prior to any exercise all participants will be required to complete a Physical Activity Readiness Questionnaire (PAR-Q+) safe exercise participation screening form for known or suspected chronic disease risk factors (this tool is used for screening purposes only).
Resting metabolic rate will be determined using the same electrochemical analyzers (on the same metabolic cart) as the exercise measures, except a different flowmeter and gas collection system will be used (namely, we will use a canopy rather than a face mask). This will allow the participant to relax and rest normally without the need of having their nose and mouth covered by a rubber mask, as their entire head and shoulders will be contained within a canopy to collect gases. This system is identical to those used in-hospital.
- Conditions
- Sedentary Lifestyle
- Being tested
- Standing Desk, Traditional 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.
Standing DeskBehavioural
Participants will be provided with a standing desk for 3 months
Traditional DeskBehavioural
Participants will use a traditional seated desk for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Standing Desk | Experimental | Will use standing desk for 3 months Receives: Behavioral: Standing Desk |
| Traditional Desk | Active comparator | Will use traditional desk for 3 months Receives: Behavioral: Traditional Desk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycoslyated Hemoglobin (HbA1C)
HbA1c will be measured at baseline and 3 months in both conditions in all participants using a bench-top analyzer.
Measured: 3 months
Secondary outcomes (9)
Sedentary Time
Sedentary time will be measured at baseline and 3 months using an activPAL inclinometer.
Measured: 3 months
Aerobic Fitness (VO2max)
Aerobic Fitness will be measured at baseline and 3 months using a sub-maximal fitness test.
Measured: 3 months
Augmentation Index
Augmentation Index will be measured at baseline and 3 months using a Sphygmocor pulse wave applanation tonomoter.
Measured: 3 months
Waist Circumference
Waist circumference will be measured at baseline and 3 months at the level of the iliac crest.
Measured: 3 months
Physical Activity
Physical activity will be measured at baseline and 3 months using an activPAL inclinometer.
Measured: 3 months
Triglycerides
Plasma triglycerides will be measured at baseline and at 3 months using a bench top analyzer.
Measured: 3 months
Fasting Glucose
Fasting glucose will be measured at baseline and at 3 months using a bench top analyzer.
Measured: 3 months
LDL Cholesterol
LDL Cholesterol will be measured at baseline and at 3 months using a bench top analyzer.
Measured: 3 months
HDL Cholesterol
HDL Cholesterol will be measured at baseline and at 3 months using a bench top analyzer.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Prince Edward Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Travis Saunders, University of Prince Edward Island
- Investigators
- Jamie Burr, PhD, Principal investigator, University of Prince Edward Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342301
- Sponsor's protocol ID
- 6005871
- Status last verified
- May 2016
- First submitted
- 14 Jan 2015
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Response to Sit-stand Workstations.
- ClinicalTrials.gov ID
- NCT02342301
- Acronym / sponsor ID
- 6005871
- Conditions
- Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Prince Edward IslandUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Jan 2015 (estimated)
- 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.
We aim to determine if changing a person's workstation from a traditional seated desk to a height adjustable "standing desk" for a period of approximately 3 months is associated with alterations in traditional measures of cardiometabolic risk.
Detailed description
The present study will include 24 male and female participants 18 years of age and older who work in an office-based setting. To be included participants must be abdominally obese, defined as a waist circumference ≥ 88 cm for women, and 102 cm for men. All potential participants will be asked to come to the Human Performance Laboratory at University of Prince Edward Island and will be given an opportunity to ask questions about the study, and to read and sign the informed consent form. Once this has taken place, participants will have their waist circumference measured in order to determine whether they meet the above criteria. If not, the individual will be thanked for their time and told that they are not eligible to participate in the current study.
Lab Day 1 (baseline)
Once screening is complete, participants will have glycosylated hemoglobin checked via a simple finger prick and point-of-care analysis of a single drop of blood. (Funding dependent, a second drop of blood may be used to analyze the participant's blood lipid profile- as would be done at a typical doctor's office visit). Next we will measure the participants' resting metabolic rate, by having them lay on a hospital bed while we analyze the oxygen and carbon dioxide concentrations of the air they exhale. This will inform us as to the participant's baseline caloric needs. Blood pressure, height, weight, waist circumference and body composition will be determined following resting metabolic rate, prior to the determination of aerobic fitness using a sub-maximal exercise protocol (see below).
Augmentation Index:
Arterial stiffness will be determined using a Sphygmocor pulse wave applanation tonomoter (Atcor Medical). This device measures arterial pulse waves non-invasively through the skin at the wrist. We will use this same device to analyze the shape of the pulse wave, which will give us information about reflected pulse waves (and thus the stiffness of the arterial tree). The measure of arterial stiffness is non-invasive and pain-free and is taken using a pen-like tool pressed against the participant's skin to detect his or her pulse.
Prior to departing the lab, participants will be instructed on the use of an accelerometer-based activity monitor (20 min), which they will wear for 1 week prior to the desk intervention. During the activity monitor collection week, participants will also be instructed to wear a heart rate belt (non-invasive chest strap) for one day during working hours only (at least 4 hours of data collection) which will be analyzed after the strap is returned to the lab. Participants will then answer an online questionnaire about his/her current physical activity and sedentary behaviors. https://docs.google.com/forms/d/1fjz5ua47KzcdnhCAN7wCDGNbvy-tKSGgZKGGhIKSqQg/viewform?usp=mail_form_link . A similar questionnaire will be used for post- intervention follow-up with the tenses changed and questions about "anticipated" desk use altered to report on "actual" use (participants in the control group will be asked to answer "not applicable" for any questions related to standing desk use on the follow-up questionnaire).
Total participation Time (1.5 hr)
Once the baseline testing session is complete, participants will be randomly allocated to intervention or control groups (12 participants per group). Participants in the intervention group will be asked to complete the below intervention, while those in the control group will be asked to maintain their current lifestyle and office workstation throughout the study.
Intervention- the participant will be given a stand-up desk and asked to use it in place of their normal desk at work. Participants will again be given the activity and HR monitors to wear during the first and last 2 weeks of desk use.
Lab day 2 (post) - all measures from lab day 1 will be repeated as described above.
Aerobic Fitness- Aerobic fitness will be determined using a treadmill-based graded exercise test with analysis of expired gases. The test will consist of 2-3 increasingly more challenging stages of walking/running (through the addition of speed or incline) at a submaximal intensity. The heart rate and oxygen consumption data collected will be used to extrapolate the data to estimate maximal values. All aerobic fitness tests will be administered under the supervision of a Canadian Society for Exercise Physiology Certified Exercise Physiologist. Prior to any exercise all participants will be required to complete a Physical Activity Readiness Questionnaire (PAR-Q+) safe exercise participation screening form for known or suspected chronic disease risk factors (this tool is used for screening purposes only).
Resting metabolic rate will be determined using the same electrochemical analyzers (on the same metabolic cart) as the exercise measures, except a different flowmeter and gas collection system will be used (namely, we will use a canopy rather than a face mask). This will allow the participant to relax and rest normally without the need of having their nose and mouth covered by a rubber mask, as their entire head and shoulders will be contained within a canopy to collect gases. This system is identical to those used in-hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standing Desk | Experimental | Behavioral: Standing DeskWill use standing desk for 3 months |
| Traditional Desk | Active comparator | Behavioral: Traditional DeskWill use traditional desk for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male and female participants
- 18 years of age and older
- work in an office-based setting.
- abdominally obese, defined as a waist circumference ≥ 88 cm for women, and 102 cm for men.
Key exclusion criteria (2 listed)
- glucose lowering medication
- inability to stand or walk
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 |
|---|---|---|
| Standing DeskParticipants will be provided with a standing desk for 3 months | Behavioural | Standing Desk |
| Traditional DeskParticipants will use a traditional seated desk for 3 months | Behavioural | Traditional Desk |
Primary outcome
Glycoslyated Hemoglobin (HbA1C)
Time frame: 3 months
HbA1c will be measured at baseline and 3 months in both conditions in all participants using a bench-top analyzer.
9 secondary outcomes
Sedentary Time
Time frame: 3 months
Aerobic Fitness (VO2max)
Time frame: 3 months
Augmentation Index
Time frame: 3 months
Waist Circumference
Time frame: 3 months
Physical Activity
Time frame: 3 months
Triglycerides
Time frame: 3 months
Fasting Glucose
Time frame: 3 months
LDL Cholesterol
Time frame: 3 months
HDL Cholesterol
Time frame: 3 months
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 11 May 2016.
- 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.
Jamie Burr, PhD principal investigator
University of Prince Edward Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standing Desk and Traditional Desk in people with Sedentary Lifestyle, run by University of Prince Edward Island at 1 site in Canada.
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 2 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 11 May 2016. 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 Canada. 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?
Glycoslyated Hemoglobin (HbA1C) (time frame: 3 months). 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 11 May 2016.