Social IsolationLEAPNCT03624049
The Impact of Community Exercise on Social Connectedness and Falls in Older Adults: Leveraging Exercise to Age in Place
A study testing Exercise and Health Class in people with Social Isolation and Fall, run by Cedars-Sinai Medical Center at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Isolation, Fall
- What is being tested?
- Exercise and Health Class
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 671 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Jun 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be cognitively stable and must be 50 years or older
Who cannot join
- <50 years
- Cognitive impairment
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Roxbury Park Community Center
Beverly Hills, California, 90212
Washington Irving Branch Library
Los Angeles, California, 90018
Pan Pacific Park
Los Angeles, California, 90036
People Coordinated Services- Crenshaw
Los Angeles, California, 90043
Poinsettia Park
Los Angeles, California, 90046
Will and Ariel Durant Library
Los Angeles, California, 90046
Virtual recruiting
Los Angeles, California, 90048
Yvonne B. Burke Senior & Community Center
Los Angeles, California, 90056
West Hollywood Park Auditorium
West Hollywood, California, 90069
About this study
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)
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.
Read the 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.
- Conditions
- Social Isolation, Fall
- Being tested
- Exercise, Health Class
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Community based exercise programs held 2-3 times per week
Health ClassOther
Community based health class held 1 time per week
| Study group | Role | What they receive |
|---|---|---|
| Community Exercise Program | Other | Participation in Health Class including: Arthritis Exercise Foundation Exercise Class, Tai Chi for Arthritis, EnhanceFitness Class, or Healthier Living Class. Receives: Other: Exercise; Other: Health Class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Social Isolation
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.
Measured: Change in Duke Social Support Index from baseline will be measured at 8 weeks and 6 months.
Secondary outcomes (3)
Number of falls in the past 3 months - Reduce Falls
Number of falls in the past 3 months
Measured: Items will be measured at Baseline, 8 weeks, and 6 months
Number of falls with injury in the past 3 months - Reduce Falls
Number of falls with injury in the past 3 months
Measured: Items will be measured at Baseline, 8 weeks, and 6 months
Change in Loneliness
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.
Measured: Items will be measured at Baseline, 8 weeks, and 6 months; assessing a change in loneliness from baseline to 8 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Jun 2018
- Primary completion30 Jun 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post study
- Masking
- None (open label)
- Enrolment
- 671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish Family Service, Partners In Care Foundation, AARP Foundation
- Responsible party
- Principal investigator, Allison Mays, Cedars-Sinai Medical Center
- Investigators
- Allison Mays, MD, Principal investigator, Cedars-Sinai Medical CenterSonja Rosen, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624049
- Sponsor's protocol ID
- Pro51676
- Acronym
- LEAP
- Status last verified
- Aug 2024
- First submitted
- 12 Jul 2018
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03624049
- Acronym / sponsor ID
- LEAP / Pro51676
- Conditions
- Social Isolation, Fall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 671 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Jewish Family Service, Partners In Care Foundation, AARP Foundation
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post study
| Arm | Type | Receives |
|---|---|---|
| Community Exercise Program | Other | Other: Exercise, Other: Health ClassParticipation in Health Class including: Arthritis Exercise Foundation Exercise Class, Tai Chi for Arthritis, EnhanceFitness Class, or Healthier Living Class. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be cognitively stable and must be 50 years or older
Key exclusion criteria (2 listed)
- <50 years
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseCommunity based exercise programs held 2-3 times per week | Other | Community Exercise Program |
| Health ClassCommunity based health class held 1 time per week | Other | Community Exercise Program |
Primary outcome
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.
3 secondary outcomes
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 with injury in the past 3 months - Reduce Falls
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Mays, MD principal investigator
Cedars-Sinai Medical Center
Sonja Rosen, MD principal investigator
Cedars-Sinai Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Health Class in people with Social Isolation and Fall, run by Cedars-Sinai Medical Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Social Isolation (time frame: Change in Duke Social Support Index from baseline will be measured at 8 weeks and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.