LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation

Loneliness Clinical Trial

— LEAPTogether  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831475
• Other study ID #: STUDY00001980
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2023
• Est. completion date: May 2025

Study information

• Verified date: September 2023
• Source: Cedars-Sinai Medical Center
• Contact: Allison M Mays, MD, MAS
• Phone: (310) 385-3511
• Email: Allison.Mays[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• Current diagnosis of dementia

Related Conditions & MeSH terms

• Intergenerational Relations
• Loneliness
• Social Isolation

Intervention

Behavioral:
• Intergenerational 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.
• Peer 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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Beverly Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	FlexTogether

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Attendance over 8-weeks
Secondary	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).	baseline and 10 weeks
Secondary	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)	baseline and 10 weeks
Secondary	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)	baseline and 10 weeks
Secondary	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)	baseline and 10 weeks
Secondary	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)	baseline and 10 weeks
Secondary	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)	baseline and 10 weeks
Secondary	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)	baseline and 10 weeks
Secondary	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).	18 weeks
Secondary	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)	18 weeks
Secondary	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)	18 weeks
Secondary	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)	18 weeks
Secondary	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)	18 weeks
Secondary	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)	18 weeks
Secondary	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)	18 weeks
Secondary	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	10 weeks