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

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ClinicalTrials.gov Identifier: NCT03624049
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : May 21, 2021
Sponsor:
Collaborators:
Jewish Family Service
Partners In Care Foundation
AARP Foundation
Information provided by (Responsible Party):
Allison Mays, Cedars-Sinai Medical Center

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pre-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 : June 1, 2018
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : April 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of falls in the past 3 months - Reduce Falls [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • <50 years
  • Cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624049


Contacts
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Contact: Allison Mays, MD 310-385-3511 Allison.Mays@cshs.org
Contact: Nathalie Guevara, BS 310-248-6242 nathalie.guevara@csmns.org

Locations
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United States, California
Roxbury Park Community Center Completed
Beverly Hills, California, United States, 90212
Washington Irving Branch Library Completed
Los Angeles, California, United States, 90018
Pan Pacific Park Completed
Los Angeles, California, United States, 90036
People Coordinated Services- Crenshaw Completed
Los Angeles, California, United States, 90043
Poinsettia Park Completed
Los Angeles, California, United States, 90046
Will and Ariel Durant Library Completed
Los Angeles, California, United States, 90046
Virtual recruiting Recruiting
Los Angeles, California, United States, 90048
Contact: Nathalie Guevara    310-248-6242      
Yvonne B. Burke Senior & Community Center Completed
Los Angeles, California, United States, 90056
West Hollywood Park Auditorium Completed
West Hollywood, California, United States, 90069
Sponsors and Collaborators
Cedars-Sinai Medical Center
Jewish Family Service
Partners In Care Foundation
AARP Foundation
Investigators
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Principal Investigator: Allison Mays, MD Cedars-Sinai Medical Center
Principal Investigator: Sonja Rosen, MD Cedars-Sinai Medical Center
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Responsible Party: Allison Mays, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03624049    
Other Study ID Numbers: Pro51676
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021

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