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RecruitingNCT05831475LEAPTogetherUpdated Aug 22, 2024

LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation

An interventional study of Intergenerational Virtual Paired Exercise and Peer Virtual Paired Exercise in Social Isolation, Loneliness and Intergenerational Relations, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-22.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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
02

Conditions studied

  • Social Isolation
  • Loneliness
  • Intergenerational Relations

Keywords

  • physical activity
  • older adults
  • intergenerational
  • social isolation
  • loneliness
  • virtual exercise
03

In context

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Current diagnosis of dementia
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Peer Pairings

    Two older adults paired

    Behavioral: Peer Virtual Paired Exercise

  • Experimental
    Intergenerational Pairings

    A younger adult and older adult paired

    Behavioral: Intergenerational Virtual Paired Exercise

Interventions

  • BehavioralIntergenerational Virtual Paired Exercise

    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.

  • BehavioralPeer Virtual Paired Exercise

    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.

06

What researchers measure

Primary outcomes

  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)

    Time frame: Attendance over 8-weeks

Secondary outcomes

  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).

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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).

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 10 weeks

07

Study locations

1 of 1 sites recruiting
  • Cedars-Sinai Medical Center
    Beverly Hills, California 90211, United States
    • Allison M Mays, MD, MAS · Contact · allison.mays@cshs.org · 310-385-3511
    • Nathalie E Guevara · Contact · nathalie.guevara@csmns.org · 3102486242
    • Allison M Mays, MD,MAS · Principal investigator
    • Celina H Shirazipour, Ph.D. · Principal investigator
    • Sonja Rosen, MD,FACP,AGSF · Principal investigator
    • Nathalie Guevara · Sub investigator
    • Bianca Luna-Luperico · Sub investigator
    Recruiting
08

References and documents

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

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05831475
Lead sponsor
Cedars-Sinai Medical Center
Collaborators
FlexTogether
Responsible party
Allison Mays (Principal Investigator, Cedars-Sinai Medical Center) — Principal investigator
First posted
Apr 26, 2023
Start date
Sep 7, 2023
Primary completion
May 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Aug 22, 2024

Study contacts

Allison M Mays, MD, MAS
Contact
Allison.Mays@cshs.org
(310) 385-3511
Nathalie Guevara
Contact
nathalie.guevara@csmns.org
310-248-6242
Celina H Shirazipour, Ph.D.
principal investigator · Cedars-Sinai Medical Center
Allison M Mays, MD, MAS
principal investigator · Cedars-Sinai Medical Center
Sonja Rosen, MD, FACP, AGSF
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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