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Social IsolationLEAPTogetherNCT05831475

LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation

A study testing Intergenerational Virtual Paired Exercise and Peer Virtual Paired Exercise in people with Social Isolation and Loneliness, run by Cedars-Sinai Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Older adult participants will engage in exercise videos twice a week for 8 weeks either while paired with a peer (same age group) or paired with a younger adult with the ability to simultaneously video chat while exercising. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Intergenerational Virtual Paired Exercise and Peer Virtual Paired Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
7 Sep 2023to 25 Mar 2026
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Verbal informed consent obtained from subject and ability for subject to comply with the requirements of the study
  • Age 18-30 years for younger adults
  • Age greater than or equal to 65 years for older adults
  • Has access to a tablet, laptop, or desktop computer with video capabilities connected to the internet with a screen at least 13 inches across
  • Able to read, write, and understand English
  • Has a 5 x 6 foot space at home in which to exercise

Who cannot join

  • Current diagnosis of dementia

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cedars-Sinai Medical Center

    Beverly Hills, California, 90211

Other trials in United States

About this study

Official title: Leveraging Exercise to Age in Place (LEAP) Together: An Intergenerational Intervention to Address Loneliness and Social Isolation

Older adult participants will engage in exercise videos twice a week for 8 weeks either while paired with a peer (same age group) or paired with a younger adult with the ability to simultaneously video chat while exercising.

Read the detailed description

Participation in this study includes:

  • Completing assessments at baseline (start of study), 8 weeks, and 16 weeks
  • Initial meeting with an Exercise Physiologist to determine exercise interests and preferences
  • Being matched with an exercise partner
  • Virtually meeting with partner to engage in exercise videos via the FlexTogether platform (meet twice a week for a total of 8 weeks)
  • Attend a live group class once a month
  • Completing an exit interview

Primary Objective:

To assess feasibility by monitoring adherence to an 8-week virtual paired exercise program for older adults

Secondary Objectives:

  1. To mechanistically investigate the key social pairing components (i.e., older adults together, younger and older adult pairing) within a virtual program necessary to enhance social connectedness, decrease loneliness, improve well-being, and increase physical activity in older adults and younger adult participants in the short-term (pre-post) through surveys and qualitative interviews
  2. To mechanistically investigate the key social pairing components (i.e., older adults together, younger and older adult pairing) within a virtual program necessary to enhance social connectedness, decrease loneliness, improve well-being, and increase physical activity in older adults and younger adult participants in the long-term (8 weeks post-intervention / 18 weeks on study) through surveys and qualitative interviews
Being tested
Intergenerational Virtual Paired Exercise, Peer Virtual Paired Exercise
Keywords
physical activity, older adults, intergenerational, social isolation, loneliness, virtual exercise
Medical subject headings
Social Isolation, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intergenerational Virtual Paired ExerciseBehavioural

    Participants will be paired with someone older/ younger and will engage in exercise videos with the ability to simultaneously video chat with their partner while exercising. Participants will log on with their partner twice a week for 8 weeks.

  • Peer Virtual Paired ExerciseBehavioural

    Participants will be paired with someone of the same age group and will engage in exercise videos with the ability to simultaneously video chat with their partner while exercising. Participants will log on with their partner twice a week for 8 weeks.

Study groups in NCT05831475
Study groupRoleWhat they receive
Peer PairingsExperimentalTwo older adults paired
Receives: Behavioral: Peer Virtual Paired Exercise
Intergenerational PairingsExperimentalA younger adult and older adult paired
Receives: Behavioral: Intergenerational Virtual Paired Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to an 8-week virtual paired exercise program for older adults

    Adherence defined as attending at least 12 out of 16 sessions (70% attendance)

    Measured: Attendance over 8-weeks

Secondary outcomes (15)
  1. social connectedness per units in scale

    To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to enhance social connectedness in the short-term (pre-post) through Duke Social Support Index (min score- 11, max score- 33; higher score indicates higher social support and interaction).

    Measured: baseline and 10 weeks

  2. pre/post loneliness per units in scale

    To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to decrease loneliness in the short-term (pre-post) through UCLA Loneliness Survey (min score- 3, max score- 9; higher scores correspond to higher feelings of loneliness)

    Measured: baseline and 10 weeks

  3. pre/post emotional, social, and psychological well-being per units in scale

    To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to improve well-being in the short-term (pre-post) through Mental Health Continuum Short-Form (min score- 14, max score- 84; higher scores indicate greater levels of positive well-being)

    Measured: baseline and 10 weeks

  4. pre/post expectations regarding aging per units in scale

    To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to improve well-being in the short-term (pre-post) through Expectations Regarding Aging Survey (min score- 12, max score- 48; higher score indicates higher (positive) expectations of aging)

    Measured: baseline and 10 weeks

  5. pre/post generativity per units in scale

    To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to improve well-being in the short-term (pre-post) through Baltimore Experience Corps Trial Generativity Scale (min score- 13, max score- 65; higher score indicates higher levels of generativity)

    Measured: baseline and 10 weeks

  6. pre/post physical activity per units in scale

    To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to increase physical activity in older adults and younger adult participants in the short-term (pre-post) through Godin Leisure Time Exercise Questionnaire (min score- 0, max score- 24+; total of 14 or less indicates insufficient activity/sedentary lifestyle, 24 units or more indicates active lifestyle)

    Measured: baseline and 10 weeks

  7. pre/post physical activity per 30 second sit to stand

    To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to increase physical activity in older adults and younger adult participants in the short-term (pre-post) through 30 second sit to stand (how many times can the participant sit and stand without using their hands in a 30 second period, higher number indicates higher level of endurance)

    Measured: baseline and 10 weeks

  8. long-term social connectedness per units in scale

    To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to enhance social connectedness in the long-term (4.5 months/18 weeks) through Duke Social Support Index (min score- 11, max score- 33; higher score indicates higher social support and interaction).

    Measured: 18 weeks

  9. long-term loneliness per units in scale

    To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to decrease loneliness in the long-term (4.5 months/18 weeks) through UCLA Loneliness Survey (min score- 3, max score- 9; higher scores correspond to higher feelings of loneliness)

    Measured: 18 weeks

  10. long-term expectations regarding aging per units in scale

    To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to improve well-being in the long-term (4.5 months/18 weeks) through Expectations Regarding Aging Survey (min score- 12, max score- 48; higher score indicates higher (positive) expectations of aging)

    Measured: 18 weeks

  11. long-term emotional, social, and psychological well-being per units in scale

    To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to improve well-being in the long-term (4.5 months/18 weeks) through Mental Health Continuum Short-Form (min score- 14, max score- 84; higher scores indicate greater levels of positive well-being)

    Measured: 18 weeks

  12. long-term generativity per units in scale

    To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to improve well-being in the long-term (4.5 months/18 weeks) through Baltimore Experience Corps Trial Generativity Scale (min score- 13, max score- 65; higher score indicates higher levels of generativity)

    Measured: 18 weeks

  13. long-term physical activity per units in scale

    To mechanistically investigate the key social pairing components within a virtual program necessary to increase physical activity in older adults and younger adult participants in the long-term (4.5 months/18 weeks) through Godin Leisure Time Exercise Questionnaire (min score- 0, max score- 24+; total of 14 or less indicates insufficient activity/sedentary lifestyle, 24 units or more indicates active lifestyle)

    Measured: 18 weeks

  14. long-term physical activity per 30 second sit to stand

    To mechanistically investigate the key social pairing components within a virtual program necessary to increase physical activity in older adults and younger adult participants in the long-term (4.5 months/18 weeks) through 30 second sit to stand (how many times can the participant sit and stand without using their hands in a 30 second period, higher number indicates higher level of endurance)

    Measured: 18 weeks

  15. Key social pairing components in virtual programming

    Qualitative interview to capture any other thoughts and observations from participants that are not easily captured in surveys

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2023
  2. Study start7 Sep 2023
  3. Primary completion25 Mar 2026
  4. Study completion25 Mar 2026

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Participants will be randomized by the coordinator to a study arm: Arm 1- older adult paired with older adult (40) Arm 2- older adult paired with younger adult (20 older, 20 younger)
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05831475
Sponsor's protocol ID
STUDY00001980
Acronym
LEAPTogether
Status last verified
Oct 2026
First submitted
6 Feb 2023
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Steptoe A, Shankar A, Demakakos P, Wardle J. Social isolation, loneliness, and all-cause mortality in older men and women. Proc Natl Acad Sci U S A. 2013 Apr 9;110(15):5797-801. doi: 10.1073/pnas.1219686110. Epub 2013 Mar 25.

    PubMed 23530191
  • Tiwari SC. Loneliness: A disease? Indian J Psychiatry. 2013 Oct;55(4):320-2. doi: 10.4103/0019-5545.120536. No abstract available.

    PubMed 24459300
  • Perissinotto CM, Stijacic Cenzer I, Covinsky KE. Loneliness in older persons: a predictor of functional decline and death. Arch Intern Med. 2012 Jul 23;172(14):1078-83. doi: 10.1001/archinternmed.2012.1993.

    PubMed 22710744
  • Ronzi S, Orton L, Pope D, Valtorta NK, Bruce NG. What is the impact on health and wellbeing of interventions that foster respect and social inclusion in community-residing older adults? A systematic review of quantitative and qualitative studies. Syst Rev. 2018 Jan 30;7(1):26. doi: 10.1186/s13643-018-0680-2.

    PubMed 29382375
  • Teater B. Intergenerational Programs to Promote Active Aging: The Experiences and Perspectives of Older Adults. Activities, Adaptation & Aging. 2016/01/02 2016;40(1):1-19. doi:10.1080/01924788.2016.1127041

  • Peters R, Ee N, Ward SA, Kenning G, Radford K, Goldwater M, Dodge HH, Lewis E, Xu Y, Kudrna G, Hamilton M, Peters J, Anstey KJ, Lautenschlager NT, Fitzgerald A, Rockwood K. Intergenerational Programmes bringing together community dwelling non-familial older adults and children: A Systematic Review. Arch Gerontol Geriatr. 2021 May-Jun;94:104356. doi: 10.1016/j.archger.2021.104356. Epub 2021 Jan 28.

    PubMed 33567363
  • Kim Y, Kim J, Lee JM, Seo DC, Jung HC. Intergenerational Taekwondo Program: A Narrative Review and Practical Intervention Proposal. Int J Environ Res Public Health. 2022 Apr 26;19(9):5247. doi: 10.3390/ijerph19095247.

    PubMed 35564642
  • Rizzo N. Fitness Industry Statistics 2021-2028 [Market Research]. 2021. https://runrepeat.com/fitness-industry

  • Russell D, Peplau LA, Ferguson ML. Developing a measure of loneliness. J Pers Assess. 1978 Jun;42(3):290-4. doi: 10.1207/s15327752jpa4203_11.

    PubMed 660402
  • Koenig HG, Westlund RE, George LK, Hughes DC, Blazer DG, Hybels C. Abbreviating the Duke Social Support Index for use in chronically ill elderly individuals. Psychosomatics. 1993 Jan-Feb;34(1):61-9. doi: 10.1016/S0033-3182(93)71928-3.

    PubMed 8426892
  • Rikli RE, Jones CJ. Development and Validation of a Functional Fitness Test for Community-Residing Older Adults. Journal of Aging and Physical Activity. 01 Apr. 1999 1999;7(2):129-161. doi:10.1123/japa.7.2.129

Questions about this trial

What is this clinical trial studying?

A study testing Intergenerational Virtual Paired Exercise and Peer Virtual Paired Exercise in people with Social Isolation and Loneliness, run by Cedars-Sinai Medical Center at 1 site 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 6 inclusion and 1 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Adherence to an 8-week virtual paired exercise program for older adults (time frame: Attendance over 8-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05831475, which also lists 11 linked publications.

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 23 Oct 2026.

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