Clinical trial NCT03624049: The Impact of Community Exercise on Social Connectedness and Falls in Older Adults: Leveraging Exercise to Age in Place
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Isolation
Fall
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Jewish Family Service
name: Partners In Care Foundation
name: AARP Foundation
First posted: 2018-08-09
Enrollment: 671
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post study
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* \<50 years
* Cognitive impairment

Primary outcomes:
measure: Change in Social Isolation
timeFrame: Change in Duke Social Support Index from baseline will be measured at 8 weeks and 6 months.
Secondary outcomes:
measure: Number of falls in the past 3 months - Reduce Falls
timeFrame: Items will be measured at Baseline, 8 weeks, and 6 months
measure: Number of falls with injury in the past 3 months - Reduce Falls
timeFrame: Items will be measured at Baseline, 8 weeks, and 6 months
measure: Change in Loneliness
timeFrame: Items will be measured at Baseline, 8 weeks, and 6 months; assessing a change in loneliness from baseline to 8 weeks and 6 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Roxbury Park Community Center
state: California
city: Los Angeles
country: United States
facility: Washington Irving Branch Library
state: California
city: Los Angeles
country: United States
facility: Pan Pacific Park
state: California
city: Los Angeles
country: United States
facility: People Coordinated Services- Crenshaw
state: California
city: Los Angeles
country: United States
facility: Poinsettia Park
state: California
city: Los Angeles
country: United States
facility: Will and Ariel Durant Library
state: California
city: Los Angeles
country: United States
facility: Virtual recruiting
state: California
city: Los Angeles
country: United States
facility: Yvonne B. Burke Senior & Community Center
state: California
city: West Hollywood
country: United States
facility: West Hollywood Park Auditorium
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Allison Mays, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Sonja Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References: