ClinicalTrials.gg
CompletedNCT03412084Updated Dec 16, 2020Results posted

A "Stand Up and Move More" Intervention for Older Adults

An interventional study of Stand up and move more in Sedentary Lifestyle, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 56 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-16.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
56 Years and older
Sex
All
01

Study summary

The purpose of the expanded study is to examine the effectiveness of a "Stand Up and Move More" intervention to reduce sedentary behavior in older adults from underserved communities.

Read the detailed description

Based on successful pilot research in Rock County, WI, and the receipt of funding from the National Institutes of Health, the investigators expanded research to additional counties in Wisconsin for a total of four counties (i.e., Dane, Iowa, Rock, and Vilas counties). Sample size will increase and participants will be randomly assigned to the intervention group (Stand Up and Move More group) or a wait-list control group (who receive the intervention after 12 weeks). The Stand Up and Move More intervention/workshop involves sessions once/week for four weeks with a refresher session at 8 weeks. Assessments will be conducted before the intervention/workshop begins, and then again at 4 weeks and 12 weeks. We have added several questionnaires to examine potential mediators of behavior change (e.g., self-efficacy, self-regulation, outcome expectancies).

02

Conditions studied

  • Sedentary Lifestyle

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Keywords

  • Sedentary Lifestyle
  • physical function
03

In context

Sedentary Behavior

1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.

This study's enrollment of 84 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.

Browse Sedentary Behavior studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.

Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
56 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • adults older than 55 yrs of age
  • inactive or low active (i.e., less than 60 minutes of physical activity/week)
  • residents of Dane, Iowa, Rock or Vilas counties, and
  • residing in a home or an apartment.

Exclusion criteria

Exclusion Criteria:

  • low levels of sedentary behavior (less than or equal to 6 hours/day),
  • recent hospitalization (i.e., past month),
  • uncontrolled medical conditions including: uncontrolled hypertension, heart disease, actively receiving chemotherapy or palliative care for cancer, stage 4 liver disease, end-stage renal or pulmonary disease, severe arthritis or any other orthopedic condition that could be made worse by standing up and moving more;
  • inability to stand up without assistance of another person, and
  • inability to speak or hear spoken English.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    Stand up intervention

    four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting

    Behavioral: Stand up and move more

  • No intervention
    Control

    No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group

Interventions

  • BehavioralStand up and move more

    4 week behavioral intervention involving the development and implementation of action plans

06

What researchers measure

Primary outcomes

  1. Total Sedentary Time Per Day

    Participants wore monitors during the day to assess total sitting time/day

    Time frame: Baseline, 4 weeks, 12 weeks

Secondary outcomes

  1. Short Physical Performance Battery (SPPB) Score

    The SPPB is an assessment of physical limitations. It combines scores from a balance test, gait speed test, and a chair stand test. The total possible range of scores is 1-12, higher scores indicate better function/less functional limitations.

    Time frame: Baseline, 4 weeks, 12 weeks

07

Results

Posted Dec 16, 2020

Participant flow

Participant flow — Overall Study
MilestoneStand up InterventionControl
Started4836
Completed4435
Not completed41
Withdrew: Withdrawal by subject20
Withdrew: Participant moved10
Withdrew: Lost to follow-up11

Outcome measures

PrimaryTotal Sedentary Time Per Day

Participants wore monitors during the day to assess total sitting time/day

Time frame:
Baseline, 4 weeks, 12 weeks
Reported as:
Mean · minute/day
Total Sedentary Time Per Day
minute/dayStand up InterventionControl
Baseline618 ± 119660 ± 153
4 weeks564 ± 119650 ± 117
12 weeks602 ± 116617 ± 120
SecondaryShort Physical Performance Battery (SPPB) Score

The SPPB is an assessment of physical limitations. It combines scores from a balance test, gait speed test, and a chair stand test. The total possible range of scores is 1-12, higher scores indicate better function/less functional limitations.

Time frame:
Baseline, 4 weeks, 12 weeks
Reported as:
Mean · score on a scale
Short Physical Performance Battery (SPPB) Score
score on a scaleStand up InterventionControl
Baseline8.05 ± 2.467.65 ± 2.60
4 weeks9.29 ± 2.657.44 ± 2.31
12 weeks10.45 ± 2.018.00 ± 2.81

Adverse events

Collected over up to 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Stand up Intervention0/48 (0%)0/48 (0%)0/48 (0%)
Control0/36 (0%)0/36 (0%)0/36 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Stand up InterventionControlTotal
Mean72 ± 973.5 ± 673 ± 8
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Stand up InterventionControlTotal
Gender — Female423274
Gender — Male639
Gender — Unknown011
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Stand up InterventionControlTotal
Hispanic or Latino000
Not Hispanic or Latino372360
Unknown or Not Reported111324
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Stand up InterventionControlTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American15924
White312556
More than one race022
Unknown or Not Reported202
Region of Enrollment
Region of Enrollment(participants)Stand up InterventionControlTotal
United States483684
08

Study locations

1 site
  • Kelli Koltyn
    Madison, Wisconsin 53706, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Dec 2019, 20 months.

Results were first posted in Dec 2020, 1 year after primary completion.

Of 733 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 20 months is above that.

Counting every sponsor, half of 741 studies reached it within 14 months; a quarter within 6 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2018
First posted
Jan 26, 2018
StartActual
Mar 14, 2018
Primary completionActual
Dec 1, 2019
CompletionActual
Dec 1, 2019
Results first posted
Dec 16, 2020
Last update
Dec 16, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03412084
Responsible party
Sponsor
First posted
Jan 26, 2018
Start date
Mar 14, 2018
Primary completion
Dec 1, 2019
Completion
Dec 1, 2019
Results posted
Dec 16, 2020
Last update
Dec 16, 2020

Study contacts

Kelli Koltyn, PhD
principal investigator · UW-Madison

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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