The Impact of Community Exercise on Social Connectedness and Falls in Older Adults: Leveraging Exercise to Age in Place

Fall Clinical Trial

— LEAP  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03624049
• Other study ID #: Pro51676
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fall
• Social Isolation

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