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Clinical Trials/NCT03624049
NCT03624049
Completed
Not Applicable

The Impact of Expanding a Community-Based Exercise Program on Social Connectedness and Falls Prevention in Older Adults: Leveraging Exercise to Age in Place (LEAP)

Cedars-Sinai Medical Center9 sites in 1 country671 target enrollmentJune 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Social Isolation
Sponsor
Cedars-Sinai Medical Center
Enrollment
671
Locations
9
Primary Endpoint
Change in Social Isolation
Status
Completed
Last Updated
last year

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Allison Mays

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

Inclusion Criteria

  • Must be cognitively stable and must be 50 years or older

Exclusion Criteria

  • \<50 years
  • Cognitive impairment

Outcomes

Primary Outcomes

Change in Social Isolation

Time Frame: Change in Duke Social Support Index from baseline will be measured at 8 weeks and 6 months.

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.

Secondary Outcomes

  • Number of falls with injury in the past 3 months - Reduce Falls(Items will be measured at Baseline, 8 weeks, and 6 months)
  • Number of falls in the past 3 months - Reduce Falls(Items will be measured at Baseline, 8 weeks, and 6 months)
  • Change in 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)

Study Sites (9)

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