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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03412084
Other study ID # 2013-1155
Secondary ID R21AG054916A1760
Status Completed
Phase N/A
First received
Last updated
Start date March 14, 2018
Est. completion date December 1, 2019

Study information

Verified date November 2020
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 56 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Stand up and move more
4 week behavioral intervention involving the development and implementation of action plans

Locations

Country Name City State
United States Kelli Koltyn Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Sedentary Time Per Day Participants wore monitors during the day to assess total sitting time/day Baseline, 4 weeks, 12 weeks
Secondary 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. Baseline, 4 weeks, 12 weeks
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