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Completed

NCT Number: NCT03624049

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

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.

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Key information

Conditions

Social Isolation Behavior Fall Social Behavior

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roxbury Park Community Center, Beverly Hills, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • <50 years
  • Cognitive impairment

Treatment and study plan

Exercise

Other

Community based exercise programs held 2-3 times per week

Health Class

Other

Community based health class held 1 time per week

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • AARP Foundation
  • Jewish Family Service
  • Partners In Care Foundation

Registry information

Official study 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)

Acronym: LEAP

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Aug 9, 2018
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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