Diabete MellitusSTANDNCT04410055
Non-exercise Physical Activity Intervention
A study testing Sitting, Static standing and Dynamic standing in people with Diabete Mellitus and Aging, run by Science and Research Centre Koper at 1 site in United States.
Trial summary
Physical inactivity is prevalent in older adults and poses a risk factor for the development of type 2 diabetes. The aim of this pilot study was to examine the effect of non-exercise physical activity using a standing desk on clinical variables in older adults with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Diabete Mellitus, Aging, Cognitive Change
- What is being tested?
- Sitting, Static standing and Dynamic standing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2012to 8 Jan 2022
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- older participants (65+ years) with clinically confirmed type 2 diabetes
- Body mass index above 25 and less than 40 kg/m2
Who cannot join
- participants unable to perform a short clinical and motor function test battery (sABC test, Mini-BEST)
Trial locations and contacts
1 site in 1 country.
Nicolaas Bohnen, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48104
Martijn Muller, PhD, 734-998-8400, mtmuller@umich.edu
Nico Bohnen, MD, PhD, +1734-998-8400, nbohnen@umich.edu
About this study
Official title: Effects of Dynamic Standing vs. Static Standing on Subjective Fatigue Symptoms
Physical inactivity is prevalent in older adults and poses a risk factor for the development of type 2 diabetes. The aim of this pilot study was to examine the effect of non-exercise physical activity using a standing desk on clinical variables in older adults with type 2 diabetes.
- Conditions
- Diabete Mellitus, Aging, Cognitive Change
- Being tested
- Sitting, Static standing, Dynamic standing
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SittingBehavioural
Also called SIT
We proposed a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions were applied: 3 hours of sitting, static standing and dynamic standing. Both standing conditions were done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)
Static standingBehavioural
Also called STAT
We proposed a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions were applied: 3 hours of sitting, static standing and dynamic standing. Both standing conditions were done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)
Dynamic standingBehavioural
Also called DYN
We proposed a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions were applied: 3 hours of sitting, static standing and dynamic standing. Both standing conditions were done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)
| Study group | Role | What they receive |
|---|---|---|
| Sitting | Active comparator | Three hours of sitting condition with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales were monitored. Receives: Behavioral: Sitting |
| Static standing | Active comparator | Four hours of static standing condition with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales were monitored. Receives: Behavioral: Static standing |
| Dynamic standing | Active comparator | Four hours of dynamic standing condition with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales were monitored. Receives: Behavioral: Dynamic standing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption
Oxygen uptake VO2 (ml/min/kg)
Measured: change in oxygen consumption between all three conditions, which will be measured with a minimum washout period of 3 days
Secondary outcomes (2)
Executive control
Executive functions measured with Trail Making Test (seconds)
Measured: change in executive control and cognitive switching levels between all three conditions, which will be measured with a minimum washout period of 3 days
Attention levels
Measuring attention with Stroop test (seconds)
Measured: change in attentional levels between all three conditions, which will be measured with a minimum washout period of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start8 Jan 2012
- Primary completion8 Jan 2022 (estimated)
- Study completion8 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabete MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Science and Research Centre Koper
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410055
- Sponsor's protocol ID
- STAND
- Acronym
- STAND
- Status last verified
- May 2020
- First submitted
- 23 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dempsey PC, Larsen RN, Sethi P, Sacre JW, Straznicky NE, Cohen ND, Cerin E, Lambert GW, Owen N, Kingwell BA, Dunstan DW. Benefits for Type 2 Diabetes of Interrupting Prolonged Sitting With Brief Bouts of Light Walking or Simple Resistance Activities. Diabetes Care. 2016 Jun;39(6):964-72. doi: 10.2337/dc15-2336. Epub 2016 Apr 13.
PubMed 27208318Wheeler MJ, Green DJ, Ellis KA, Cerin E, Heinonen I, Naylor LH, Larsen R, Wennberg P, Boraxbekk CJ, Lewis J, Eikelis N, Lautenschlager NT, Kingwell BA, Lambert G, Owen N, Dunstan DW. Distinct effects of acute exercise and breaks in sitting on working memory and executive function in older adults: a three-arm, randomised cross-over trial to evaluate the effects of exercise with and without breaks in sitting on cognition. Br J Sports Med. 2020 Jul;54(13):776-781. doi: 10.1136/bjsports-2018-100168. Epub 2019 Apr 29.
PubMed 31036563Sui W, Smith ST, Fagan MJ, Rollo S, Prapavessis H. The effects of sedentary behaviour interventions on work-related productivity and performance outcomes in real and simulated office work: A systematic review. Appl Ergon. 2019 Feb;75:27-73. doi: 10.1016/j.apergo.2018.09.002. Epub 2018 Sep 18.
PubMed 30509536Marusic U, Muller MLTM, Alexander NB, Bohnen NI. Feasibility and behavioral effects of prolonged static and dynamic standing as compared to sitting in older adults with type 2 diabetes mellitus. BMC Geriatr. 2020 Jun 11;20(1):204. doi: 10.1186/s12877-020-01600-0.
PubMed 32527223
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dynamic Standing vs. Static Standing on Subjective Fatigue Symptoms
- ClinicalTrials.gov ID
- NCT04410055
- Acronym / sponsor ID
- STAND / STAND
- Conditions
- Diabete Mellitus, Aging, Cognitive Change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Science and Research Centre KoperUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 8 Jan 2012 (actual)
- Primary completion
- 8 Jan 2022 (estimated)
- Study completion
- 8 Jan 2022 (estimated)
- First posted
- 1 Jun 2020 (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.
Physical inactivity is prevalent in older adults and poses a risk factor for the development of type 2 diabetes. The aim of this pilot study was to examine the effect of non-exercise physical activity using a standing desk on clinical variables in older adults with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sitting | Active comparator | Behavioral: SittingThree hours of sitting condition with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales were monitored. |
| Static standing | Active comparator | Behavioral: Static standingFour hours of static standing condition with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales were monitored. |
| Dynamic standing | Active comparator | Behavioral: Dynamic standingFour hours of dynamic standing condition with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales were monitored. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- older participants (65+ years) with clinically confirmed type 2 diabetes
- Body mass index above 25 and less than 40 kg/m2
Key exclusion criteria (1 listed)
- participants unable to perform a short clinical and motor function test battery (sABC test, Mini-BEST)
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 |
|---|---|---|
| SittingAlso: SITWe proposed a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions were applied: 3 hours of sitting, static standing and dynamic standing. Both standing conditions were done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA) | Behavioural | Sitting |
| Static standingAlso: STATWe proposed a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions were applied: 3 hours of sitting, static standing and dynamic standing. Both standing conditions were done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA) | Behavioural | Static standing |
| Dynamic standingAlso: DYNWe proposed a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions were applied: 3 hours of sitting, static standing and dynamic standing. Both standing conditions were done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA) | Behavioural | Dynamic standing |
Primary outcome
Oxygen consumption
Time frame: change in oxygen consumption between all three conditions, which will be measured with a minimum washout period of 3 days
Oxygen uptake VO2 (ml/min/kg)
2 secondary outcomes
Executive control
Time frame: change in executive control and cognitive switching levels between all three conditions, which will be measured with a minimum washout period of 3 days
Attention levels
Time frame: change in attentional levels between all three conditions, which will be measured with a minimum washout period of 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Background: PubMed 27208318Dempsey PC, Larsen RN, Sethi P, Sacre JW, Straznicky NE, Cohen ND, Cerin E, Lambert GW, Owen N, Kingwell BA, Dunstan DW. Benefits for Type 2 Diabetes of Interrupting Prolonged Sitting With Brief Bouts of Light Walking or Simple Resistance Activities. Diabetes Care. 2016 Jun;39(6):964-72. doi: 10.2337/dc15-2336. Epub 2016 Apr 13.
- Background: PubMed 31036563Wheeler MJ, Green DJ, Ellis KA, Cerin E, Heinonen I, Naylor LH, Larsen R, Wennberg P, Boraxbekk CJ, Lewis J, Eikelis N, Lautenschlager NT, Kingwell BA, Lambert G, Owen N, Dunstan DW. Distinct effects of acute exercise and breaks in sitting on working memory and executive function in older adults: a three-arm, randomised cross-over trial to evaluate the effects of exercise with and without breaks in sitting on cognition. Br J Sports Med. 2020 Jul;54(13):776-781. doi: 10.1136/bjsports-2018-100168. Epub 2019 Apr 29.
- Background: PubMed 30509536Sui W, Smith ST, Fagan MJ, Rollo S, Prapavessis H. The effects of sedentary behaviour interventions on work-related productivity and performance outcomes in real and simulated office work: A systematic review. Appl Ergon. 2019 Feb;75:27-73. doi: 10.1016/j.apergo.2018.09.002. Epub 2018 Sep 18.
- Derived from this study: PubMed 32527223Marusic U, Muller MLTM, Alexander NB, Bohnen NI. Feasibility and behavioral effects of prolonged static and dynamic standing as compared to sitting in older adults with type 2 diabetes mellitus. BMC Geriatr. 2020 Jun 11;20(1):204. doi: 10.1186/s12877-020-01600-0.
- 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.
Nicolaas Bohnen, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitting, Static standing and Dynamic standing in people with Diabete Mellitus and Aging, run by Science and Research Centre Koper 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolaas Bohnen, MD, PhD (nbohnen@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption (time frame: change in oxygen consumption between all three conditions, which will be measured with a minimum washout period of 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04410055, which also lists 4 linked publications.
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 1 Jun 2020.