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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Virtual Paired Exercises for Loneliness?

Research shows that exercise programs delivered via videoconferencing can be as effective as face-to-face programs for improving physical health in older adults and people with chronic diseases. Additionally, online-supervised exercise programs have been found to improve physical outcomes and quality of life, suggesting that virtual paired exercises could help reduce loneliness by promoting social interaction and physical activity. ^{1 2 3 4 5}

Is virtual paired exercise safe for humans?

Research on online exercise programs, including those delivered via videoconference, suggests they are generally safe for older adults and can help improve physical and psychological health. These programs have been tested in various groups, such as healthy older adults and cancer survivors, without significant safety concerns. ^{1 5 6 7 8}

How is the Virtual Paired Exercise treatment unique for addressing loneliness?

The Virtual Paired Exercise treatment is unique because it combines physical activity with social interaction through virtual pairings, either intergenerationally or with peers, to enhance social connectedness and reduce loneliness, unlike traditional physical activity programs that may not focus on social aspects. ^{9 10 11 12 13}

Research Team

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Can the Otago falls prevention program be delivered by video? A feasibility study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Remotely delivered exercise to older rural cancer survivors: a randomized controlled pilot trial. [2023]

4. England 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. [2022]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Online Exercise Programming Among Older Adults: A Scoping Review. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A Group-Based, Videoconference-Delivered Physical Activity Program for Cancer Survivors. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Time-varying associations between loneliness and physical activity: Evidence from repeated daily life assessments in an adult lifespan sample. [2023]

9. England 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. [2021]

10. New Zealand 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. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

Loneliness is associated with an increased risk of sedentary life in older Israelis. [2018]

13. Germany pubmed.ncbi.nlm.nih.gov

Peer-led exercise program for ageing adults to improve physical functions - a randomized trial. [2021]