- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04410055
Non-exercise Physical Activity Intervention (STAND)
May 27, 2020 updated by: Science and Research Centre Koper
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicolaas Bohnen, MD, PhD
- Email: nbohnen@med.umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48104
- Recruiting
- University of Michigan
-
Contact:
- Martijn Muller, PhD
- Phone Number: 734-998-8400
- Email: mtmuller@umich.edu
-
Contact:
- Nico Bohnen, MD, PhD
- Phone Number: +1734-998-8400
- Email: nbohnen@umich.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- older participants (65+ years) with clinically confirmed type 2 diabetes
- Body mass index above 25 and less than 40 kg/m2
Exclusion Criteria:
- participants unable to perform a short clinical and motor function test battery (sABC test, Mini-BEST)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sitting
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.
|
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)
Other Names:
|
Active Comparator: Static standing
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.
|
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)
Other Names:
|
Active Comparator: Dynamic standing
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.
|
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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
change in oxygen consumption between all three conditions, which will be measured with a minimum washout period of 3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Executive functions measured with Trail Making Test (seconds)
|
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
|
Measuring attention with Stroop test (seconds)
|
change in attentional levels between all three conditions, which will be measured with a minimum washout period of 3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Wheeler 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.
- Sui 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.
- Marusic 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2012
Primary Completion (Anticipated)
January 8, 2022
Study Completion (Anticipated)
January 8, 2022
Study Registration Dates
First Submitted
May 23, 2020
First Submitted That Met QC Criteria
May 27, 2020
First Posted (Actual)
June 1, 2020
Study Record Updates
Last Update Posted (Actual)
June 1, 2020
Last Update Submitted That Met QC Criteria
May 27, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STAND (Other Identifier: AgNovos)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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