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

August 21, 2024 updated by: Allison Mays, Cedars-Sinai Medical Center

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)

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

671

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Beverly Hills, California, United States, 90212
        • Roxbury Park Community Center
      • Los Angeles, California, United States, 90018
        • Washington Irving Branch Library
      • Los Angeles, California, United States, 90036
        • Pan Pacific Park
      • Los Angeles, California, United States, 90043
        • People Coordinated Services- Crenshaw
      • Los Angeles, California, United States, 90046
        • Poinsettia Park
      • Los Angeles, California, United States, 90046
        • Will and Ariel Durant Library
      • Los Angeles, California, United States, 90048
        • Virtual recruiting
      • Los Angeles, California, United States, 90056
        • Yvonne B. Burke Senior & Community Center
      • West Hollywood, California, United States, 90069
        • West Hollywood Park Auditorium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • <50 years
  • Cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Community based exercise programs held 2-3 times per week
Community based health class held 1 time per week

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Items will be measured at Baseline, 8 weeks, and 6 months
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
Items will be measured at Baseline, 8 weeks, and 6 months
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.
Items will be measured at Baseline, 8 weeks, and 6 months; assessing a change in loneliness from baseline to 8 weeks and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Pro51676

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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