- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03412084
A "Stand Up and Move More" Intervention for Older Adults
November 18, 2020 updated by: University of Wisconsin, Madison
Translating a "Stand Up and Move More" Intervention by State Aging Units to Older Adults in Underserved Communities
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
84
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 Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53706
- Kelli Koltyn
-
-
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
56 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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:
- 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.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
4 week behavioral intervention involving the development and implementation of action plans
|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Sedentary Time Per Day
Time Frame: Baseline, 4 weeks, 12 weeks
|
Participants wore monitors during the day to assess total sitting time/day
|
Baseline, 4 weeks, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Physical Performance Battery (SPPB) Score
Time Frame: Baseline, 4 weeks, 12 weeks
|
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.
|
Baseline, 4 weeks, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kelli Koltyn, PhD, UW-Madison
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)
March 14, 2018
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
January 19, 2018
First Submitted That Met QC Criteria
January 19, 2018
First Posted (Actual)
January 26, 2018
Study Record Updates
Last Update Posted (Actual)
December 16, 2020
Last Update Submitted That Met QC Criteria
November 18, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2013-1155
- A176000 (Other Identifier: UW Madison)
- EDUC/KINESIOLOGY/KINESIO (Other Identifier: UW Madison)
- R21AG054916 (U.S. NIH Grant/Contract)
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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