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Non-exercise Physical Activity Intervention (STAND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04410055
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : June 1, 2020
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Science and Research Centre Koper

Brief 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.

Condition or disease Intervention/treatment Phase
Diabete Mellitus Aging Cognitive Change Behavioral: Sitting Behavioral: Static standing Behavioral: Dynamic standing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Dynamic Standing vs. Static Standing on Subjective Fatigue Symptoms
Actual Study Start Date : January 8, 2012
Estimated Primary Completion Date : January 8, 2022
Estimated Study Completion Date : January 8, 2022

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.
Behavioral: Sitting
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 Name: SIT

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.
Behavioral: Static standing
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 Name: STAT

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.
Behavioral: Dynamic standing
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 Name: DYN




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)



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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410055


Contacts
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Contact: Nicolaas Bohnen, MD, PhD nbohnen@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48104
Contact: Martijn Muller, PhD    734-998-8400    mtmuller@umich.edu   
Contact: Nico Bohnen, MD, PhD    +1734-998-8400    nbohnen@umich.edu   
Sponsors and Collaborators
Science and Research Centre Koper
University of Michigan
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Science and Research Centre Koper
ClinicalTrials.gov Identifier: NCT04410055    
Other Study ID Numbers: STAND
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases