- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03624049
The Impact of Community Exercise on Social Connectedness and Falls in Older Adults: Leveraging Exercise to Age in Place (LEAP)
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
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
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Los Angeles, California, United States, 90043
- People Coordinated Services- Crenshaw
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Los Angeles, California, United States, 90046
- Poinsettia Park
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Los Angeles, California, United States, 90046
- Will and Ariel Durant Library
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Los Angeles, California, United States, 90048
- Virtual recruiting
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Los Angeles, California, United States, 90056
- Yvonne B. Burke Senior & Community Center
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West Hollywood, California, United States, 90069
- West Hollywood Park Auditorium
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be cognitively stable and must be 50 years or older
Exclusion Criteria:
- <50 years
- Cognitive impairment
Study Plan
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
Sponsor
Investigators
- Principal Investigator: Allison Mays, MD, Cedars-Sinai Medical Center
- Principal Investigator: Sonja Rosen, MD, Cedars-Sinai Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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