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

• Sponsor: Cedars-Sinai Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03624049
• Collaborator: Jewish Family Service (Other), Partners In Care Foundation (Other), AARP Foundation (Other)
• Enrollment: 2,600
• Locations: 9
• Arm: 1
• Anticipated Duration (Months): 46.5
• Patients Per Site: 288.9
• Patients Per Site Per Month: 6.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Social Isolation; Fall	Other: Exercise; Other: Health Class	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2600 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Pre-post studyPre-post study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Jun 1, 2018
• Anticipated Primary Completion Date: Jan 30, 2022
• Anticipated Study Completion Date: Apr 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Community Exercise Program Participation in Health Class including: Arthritis Exercise Foundation Exercise Class, Tai Chi for Arthritis, EnhanceFitness Class, or Healthier Living Class.	Other: Exercise; Community based exercise programs held 2-3 times per week; Other: Health Class; Community based health class held 1 time per week

Outcome Measures

Primary Outcome Measures

1. Change in Social Isolation [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 Outcome Measures

1. Number of falls 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

2. 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 with injury in the past 3 months

3. 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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• <50 years

• Cognitive impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roxbury Park Community Center	Beverly Hills	California	United States	90212
2	Washington Irving Branch Library	Los Angeles	California	United States	90018
3	Pan Pacific Park	Los Angeles	California	United States	90036
4	People Coordinated Services- Crenshaw	Los Angeles	California	United States	90043
5	Poinsettia Park	Los Angeles	California	United States	90046
6	Will and Ariel Durant Library	Los Angeles	California	United States	90046
7	Virtual recruiting	Los Angeles	California	United States	90048
8	Yvonne B. Burke Senior & Community Center	Los Angeles	California	United States	90056
9	West Hollywood Park Auditorium	West Hollywood	California	United States	90069

Sponsors and Collaborators

• Cedars-Sinai Medical Center
• Jewish Family Service
• Partners In Care Foundation
• AARP Foundation

Investigators

• Principal Investigator: Allison Mays, MD, Cedars-Sinai Medical Center
• Principal Investigator: Sonja Rosen, MD, Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allison Mays, Principal Investigator, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT03624049
• Other Study ID Numbers: Pro51676
• First Posted: Aug 9, 2018
• Last Update Posted: May 21, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 21, 2021