NCT04410055

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2012

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2022

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

10 years

First QC Date

May 23, 2020

Last Update Submit

May 27, 2020

Conditions

Diabete MellitusAgingCognitive Change

Outcome Measures

Primary Outcomes (1)

  • Oxygen consumption

    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 Outcomes (2)

  • Executive control

    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

    change in attentional levels between all three conditions, which will be measured with a minimum washout period of 3 days

Study Arms (3)

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.

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.

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.

Behavioral: Dynamic standing

Interventions

SittingBEHAVIORAL

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)

Also known as: SIT
Sitting
Static standingBEHAVIORAL

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)

Also known as: STAT
Static standing
Dynamic standingBEHAVIORAL

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)

Also known as: DYN
Dynamic standing

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • older participants (65+ years) with clinically confirmed type 2 diabetes
  • Body mass index above 25 and less than 40 kg/m2

You may not qualify if:

  • participants unable to perform a short clinical and motor function test battery (sABC test, Mini-BEST)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48104, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 27208318BACKGROUND

  • 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.

    PMID: 31036563BACKGROUND

  • 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.

    PMID: 30509536BACKGROUND

  • 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.

    PMID: 32527223DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Sitting Position

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Nicolaas Bohnen, MD, PhD

CONTACT

nbohnen@med.umich.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2020

First Posted

June 1, 2020

Study Start

January 8, 2012

Primary Completion

January 8, 2022

Study Completion

January 8, 2022

Last Updated

June 1, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)