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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03624049
Other study ID # Pro51676
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date December 31, 2023

Study information

Verified date February 2023
Source Cedars-Sinai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to reduce risk of falls and social isolation in older adults age 50+ through participation in community based health and exercise programs.


Description:

PRIMARY HYPOTHESES: In community-dwelling ambulatory older adults (age ≥50 years) participation in a community-based group program will improve the Duke Social Support Index (DSSI) score by four points measured after six to eight participation in the program when compared to the DSSI score prior to participation in the program. This increase will be sustained at 26 week follow-up. SECONDARY HYPOTHESES: Participants in the community-based group exercise activities will have decreased fall risk when measured after six to eight weeks participation in the program when compared to pre-participation as based on responses to the fall risk questionnaire. Cedars-Sinai patients who participate in the community-based programs will have a decrease in health care utilization (as measured by physician visits, Emergency Department visits, and hospitalizations) in the 26 weeks after program enrollment compared to the 26 weeks prior to program enrollment.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 671
Est. completion date December 31, 2023
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Must be cognitively stable and must be 50 years or older Exclusion Criteria: - <50 years - Cognitive impairment

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
Community based exercise programs held 2-3 times per week
Health Class
Community based health class held 1 time per week

Locations

Country Name City State
United States Roxbury Park Community Center Beverly Hills California
United States Pan Pacific Park Los Angeles California
United States People Coordinated Services- Crenshaw Los Angeles California
United States Poinsettia Park Los Angeles California
United States Virtual recruiting Los Angeles California
United States Washington Irving Branch Library Los Angeles California
United States Will and Ariel Durant Library Los Angeles California
United States Yvonne B. Burke Senior & Community Center Los Angeles California
United States West Hollywood Park Auditorium West Hollywood California

Sponsors (4)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center AARP Foundation, Jewish Family Service, Partners In Care Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Social Isolation The Duke Social Support Index (DSSI) is an 11 item questionnaire with a total score between 11 and 33 with higher scores indicating increased social connection and lower scores indicating higher social isolation. Change in Duke Social Support Index from baseline will be measured at 8 weeks and 6 months.
Secondary Number of falls in the past 3 months - Reduce Falls Number of falls in the past 3 months Items will be measured at Baseline, 8 weeks, and 6 months
Secondary Number of falls with injury in the past 3 months - Reduce Falls Number of falls with injury in the past 3 months Items will be measured at Baseline, 8 weeks, and 6 months
Secondary Change in Loneliness University of California Los Angeles 3 item Loneliness scale is a 3 item questionnaire with a total score between 3 and 9 with higher scores indicating increased loneliness. Items will be measured at Baseline, 8 weeks, and 6 months; assessing a change in loneliness from baseline to 8 weeks and 6 months
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