Virtual Paired Exercises for Loneliness

(LEAPTogether Trial)

Overseen By Sonja Rosen, MD,FACP,AGSF

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Dementia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 8 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if exercising with a partner can reduce loneliness in older adults. Participants will follow exercise videos twice a week for eight weeks, paired either with someone their own age or with a younger adult, with the option to video chat during exercise. The program, called Intergenerational Virtual Paired Exercise, targets older adults aged 65 and up who have space to exercise at home and access to a computer or tablet with internet. As an unphased trial, this study provides a unique opportunity to explore new methods for enhancing social connections and well-being.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this exercise program is safe for older adults?

Research has shown that virtual exercise programs, where participants pair with either younger or similar-aged partners, are generally safe and well-received by older adults. These programs offer social benefits, such as reducing loneliness, and have not revealed any major safety issues.

For programs pairing different generations, reviews of similar activities have found no serious problems. These programs often enhance social connections without causing harm.

Exercises with partners of the same age have been studied in other settings, and results suggest they are practical and safe. Those studies have reported no major safety concerns.

Since this trial is in the "Not Applicable" phase, it likely focuses on the practicality and social benefits of the programs, rather than testing new medical treatments. Participants can feel reassured about the safety of these programs based on existing evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Paired Exercises for Loneliness trial because it explores a novel approach to combating loneliness through technology-facilitated connections. Unlike traditional methods, such as therapy or social clubs, these virtual pairings allow for structured interactions between either two older adults or an older and a younger adult. This method leverages the accessibility and convenience of virtual platforms to foster meaningful connections, potentially bridging generational gaps and reducing feelings of isolation in older populations. By focusing on virtual exercises, this trial aims to provide a scalable and flexible solution to loneliness that can be adapted to individual needs and circumstances.

What evidence suggests that this trial's treatments could be effective for reducing loneliness?

Research shows that programs pairing older and younger people can reduce loneliness and improve social connections. In this trial, participants may join the Intergenerational Pairings arm, where a younger adult pairs with an older adult. A review found that these programs offer social and mental benefits, reducing isolation for older adults. Similarly, studies on virtual exercise with peers indicate that working out with someone of the same age can decrease loneliness and boost motivation. Participants in the Peer Pairings arm, where two older adults pair, may experience these benefits. Both methods seem promising for helping older adults feel less alone and more socially engaged. ^{1 4 5 6 7}

Who Is on the Research Team?

Celina H Shirazipour, Ph.D.

Principal Investigator

Cedars-Sinai Medical Center

Sonja Rosen, MD,FACP,AGSF

Principal Investigator

Cedars-Sinai Medical Center

Allison M Mays, MD, MAS

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for older adults aged 65 or above and younger adults aged 18-30 who experience loneliness or social isolation. Participants must have space at home to exercise, access to a video-capable device with internet, and be able to understand English. Those with dementia cannot join.

Inclusion Criteria

Verbal informed consent obtained from subject and ability for subject to comply with the requirements of the study

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

Exclusion Criteria

I have been diagnosed with dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments and meet with an Exercise Physiologist to determine exercise interests and preferences

1 week

1 visit (virtual)

Treatment

Participants engage in exercise videos twice a week for 8 weeks, paired with either a peer or a younger adult, and attend a live group class once a month

8 weeks

16 visits (virtual), 2 visits (virtual group class)

Follow-up

Participants are monitored for long-term effects on physical activity, social connectedness, and well-being through surveys and qualitative interviews

10 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Intergenerational Virtual Paired Exercise
• Peer Virtual Paired Exercise

Trial Overview The study tests if exercising while video chatting can help reduce loneliness. Older adults will follow exercise videos twice weekly for 8 weeks, paired either with someone their age or a younger adult, comparing the effects on social connection.

How Is the Trial Designed?

Group I: Peer Pairings Experimental Treatment 1 Intervention

Two older adults paired

Group II: Intergenerational Pairings Experimental Treatment 1 Intervention

A younger adult and older adult paired

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

FlexTogether

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

Group-based physical activity (GBPA) can significantly improve social connectedness among older adults, potentially reducing feelings of social isolation and loneliness, which are critical health issues in this population.

In addition to physical health benefits, GBPA offers a unique advantage over individual physical activity by fostering social interactions, highlighting the need for more research to develop targeted exercise programs for isolated or lonely older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group-based physical activity as a means to reduce social isolation and loneliness among older adults. Sebastião, E., Mirda, D.[2021]

In a study of 1663 older adults in Israel, loneliness was found to be significantly associated with lower levels of physical activity, particularly in women, indicating that feeling lonely may increase the risk of inactivity as people age.

The research suggests that loneliness affects physical activity levels independently of other factors like body mass index and education, highlighting the need for interventions that promote social interaction alongside physical activity to combat inactivity in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loneliness is associated with an increased risk of sedentary life in older Israelis. Netz, Y., Goldsmith, R., Shimony, T., et al.[2018]

The 'Choose to Move' (CTM) intervention significantly increased physical activity levels among older adults, with both lonely and not lonely participants showing improvements at 3 months, and maintaining higher activity levels at 6 months compared to baseline.

Loneliness decreased significantly for participants who identified as lonely at baseline, highlighting that community-based physical activity programs can effectively reduce social isolation and promote social connectedness among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It makes me feel not so alone": features of the Choose to Move physical activity intervention that reduce loneliness in older adults. Franke, T., Sims-Gould, J., Nettlefold, L., et al.[2021]

An online supervised exercise program significantly reduced fasting blood sugar and body mass index (BMI) in 70 older patients with Type 2 diabetes over a 6-week period.

While both supervised and unsupervised exercise groups showed improvements in psychological resilience and quality of life, the online supervised group demonstrated greater benefits, suggesting it may be a valuable treatment option for older adults unable to attend in-person rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an online-supervised exercise program in older people with diabetes on fasting blood sugar, psychological resilience and quality of life: A double blind randomised controlled trial. Terkes, N., Aksu, NT., Yamac, SU.[2023]

The Otago Exercise Programme delivered via an interactive DVD showed a high compliance rate of 87% among older adults, indicating that this method is feasible for promoting exercise in this population.

Participants in the intervention group experienced a significant reduction in falls risk, as measured by the Physiological Profile Assessment, demonstrating the efficacy of the OEP-DVD in improving safety and mobility among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can the Otago falls prevention program be delivered by video? A feasibility study. Davis, JC., Hsu, CL., Cheung, W., et al.[2022]

The tele-exercise program (tele-EF) was found to be feasible for older, rural cancer survivors, with a high completion rate of 95% among participants over 16 weeks.

Participants in the tele-EF group showed significant improvements in physical function and activity levels, including faster sit-to-stand times and increased daily step counts compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remotely delivered exercise to older rural cancer survivors: a randomized controlled pilot trial. Gell, NM., Dittus, K., Caefer, J., et al.[2023]

Videoconferencing exercise interventions for people with chronic diseases have been found to be effective in improving both exercise capacity and quality of life, based on a systematic review of 32 trials.

The studies showed small to moderate positive effects favoring videoconferencing compared to both non-exercising and exercising comparators, with no serious adverse events reported, indicating that this method is safe and feasible for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of exercise via telehealth for chronic disease: a systematic review and meta-analysis of exercise interventions delivered via videoconferencing. Brown, RC., Coombes, JS., Jungbluth Rodriguez, K., et al.[2022]

A 16-week randomized controlled trial with 41 healthy older adults showed that a home-based training program delivered via videoconference was as effective as face-to-face training in reducing body weight and fat mass, and improving cardiorespiratory fitness and lower limb strength.

While videoconferencing training was effective for many fitness measures, it was less effective than face-to-face training for improving certain strength metrics like handgrip and trunk extension strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-inferiority of a home-based videoconference physical training program in comparison with the same program administered face-to-face in healthy older adults: the MOTION randomised controlled trial. Langeard, A., Bigot, L., Maffiuletti, NA., et al.[2022]

A scoping review of 29 studies found that interventions using social robots or computer agents can effectively reduce loneliness in older adults, primarily by providing companionship and facilitating social interactions.

While most studies reported positive outcomes, some negative effects, such as feelings of sadness when robots were removed, highlight the need for careful consideration in the design and implementation of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Friends from the Future: A Scoping Review of Research into Robots and Computer Agents to Combat Loneliness in Older People. Gasteiger, N., Loveys, K., Law, M., et al.[2022]

A 12-week peer-led exercise program significantly improved physical function in adults aged 50 and above, with notable enhancements in tests like the chair stand and 6-minute walk test.

Participants in the intervention group also reported lower stress levels and better perceived health, indicating psychosocial benefits, although there were no significant changes in metabolic health compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-led exercise program for ageing adults to improve physical functions - a randomized trial. Bouchard, DR., Olthuis, JV., Bouffard-Levasseur, V., et al.[2021]

A review of 17 studies involving 1,767 older adults (ages 65 to 94) found that online exercise programming is primarily focused on feasibility and has the potential to promote physical activity among seniors.

Most studies delivered these programs asynchronously and assessed various health-related outcomes, indicating a need for further research on older adults' perceptions and the specific benefits of online exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Exercise Programming Among Older Adults: A Scoping Review. Dagenais, M., Parker, O., Galway, S., et al.[2023]

The 8-week group-based physical activity program delivered via videoconferencing was feasible and well-accepted by cancer survivors, with high enrollment (61 out of 65 interested) and retention rates (86.9%).

Participants showed significant improvements in physical activity levels, muscular endurance, and quality of life after the program, indicating that this innovative approach may effectively support cancer survivors in increasing their physical activity and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Group-Based, Videoconference-Delivered Physical Activity Program for Cancer Survivors. Leach, HJ., Crisafio, ME., Howell, MJ., et al.[2023]

A study involving 139 Canadian adults showed that on days when individuals felt lonelier, they engaged in significantly less moderate-to-vigorous physical activity and took fewer steps, highlighting a direct link between daily feelings of loneliness and physical activity levels.

While overall loneliness did not correlate with general physical activity levels across individuals, the findings suggest that addressing loneliness on a daily basis could be an effective strategy to encourage more physical activity, especially during challenging times like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-varying associations between loneliness and physical activity: Evidence from repeated daily life assessments in an adult lifespan sample. Broen, T., Choi, Y., Zambrano Garza, E., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12576164/

Assessing the Effectiveness of a Virtual Intergenerational ... This study aimed to assess the impact of a virtual intergenerational service-learning project on undergraduate students' ageism attitude ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05831475

Study Details | NCT05831475 | LEAPTogether: An ... Completing an exit interview. Primary Objective: To assess feasibility by monitoring adherence to an 8-week virtual paired exercise program for older adults.

3. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1386651/full

Needs of social isolation, loneliness, and intergenerational ... This scoping review examines the effectiveness of intergenerational interventions aimed at reducing social isolation and loneliness among older adults in the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S295030782500058X

Impact of intergenerational programmes on older adults for ... Intergenerational programs provided biopsychosocial benefits to generations of different ages, which helped enhance the pursuit of active ageing.

5. tandfonline.com tandfonline.com/doi/full/10.1080/15350770.2022.2113585

The Effectiveness of a Virtual Intergenerational Activity for ... We examined whether a virtual intergenerational activity was feasible and effective for reducing ageism among older (OA) and younger adults ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9222564/

Virtual Intergenerational Reverse-Mentoring Program ... This pilot evaluation suggests that reverse mentoring programs can be implemented virtually and may improve social outcomes.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9850285/

Digital Intergenerational Program to Reduce Loneliness ... This realist review aimed to identify existing digital intergenerational programs that were used to reduce loneliness or social isolation among older adults and ...