Clinical trial NCT05831475: LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation
Official title: Leveraging Exercise to Age in Place (LEAP) Together: An Intergenerational Intervention to Address Loneliness and Social Isolation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Isolation
Loneliness
Intergenerational Relations
Keywords: physical activity
older adults
intergenerational
social isolation
loneliness
virtual exercise
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: FlexTogether
First posted: 2023-04-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to an 8-week virtual paired exercise program for older adults
timeFrame: Attendance over 8-weeks
Secondary outcomes:
measure: social connectedness per units in scale
timeFrame: baseline and 10 weeks
measure: pre/post loneliness per units in scale
timeFrame: baseline and 10 weeks
measure: pre/post emotional, social, and psychological well-being per units in scale
timeFrame: baseline and 10 weeks
measure: pre/post expectations regarding aging per units in scale
timeFrame: baseline and 10 weeks
measure: pre/post generativity per units in scale
timeFrame: baseline and 10 weeks
measure: pre/post physical activity per units in scale
timeFrame: baseline and 10 weeks
measure: pre/post physical activity per 30 second sit to stand
timeFrame: baseline and 10 weeks
measure: long-term social connectedness per units in scale
timeFrame: 18 weeks
measure: long-term loneliness per units in scale
timeFrame: 18 weeks
measure: long-term expectations regarding aging per units in scale
timeFrame: 18 weeks
measure: long-term emotional, social, and psychological well-being per units in scale
timeFrame: 18 weeks
measure: long-term generativity per units in scale
timeFrame: 18 weeks
measure: long-term physical activity per units in scale
timeFrame: 18 weeks
measure: long-term physical activity per 30 second sit to stand
timeFrame: 18 weeks
measure: Key social pairing components in virtual programming
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Celina H Shirazipour, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Allison M Mays, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Sonja Rosen, MD, FACP, AGSF
role: PRINCIPAL_INVESTIGATOR
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