Caregiver Education + Remote Exercise for Down Syndrome

(CareFit DS/AD Trial)

Overseen By Joseph Sherman, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Cardiovascular, metabolic, renal disease, others

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

Compensation: Varies

Number of Visits: 38

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and feasibility of a remote exercise program combined with caregiver education for older adults with Down syndrome and their caregivers. The aim is to enhance physical activity and caregiving skills, supporting individuals with Down syndrome who may face cognitive decline. It suits adults over 35 with Down syndrome who live at home or in a supported environment and can follow simple instructions. Caregivers should be the primary support person, able to communicate in English, and willing to engage in physical activities like brisk walking. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could improve the quality of life for those with Down syndrome.

What prior data suggests that this remote exercise and caregiver education intervention is safe for older adults with Down syndrome?

Research has shown that remote exercise programs for adults with Down syndrome are generally safe. In past studies, most participants completed the exercise sessions, with nearly everyone adhering to the program. Attendance was high, with about 85% joining the exercise sessions and 86% attending support and education sessions.

Additionally, a specific 12-week remote exercise program received positive feedback, with participants attending about 89% of the group exercise sessions. These findings suggest that remote exercise and caregiver education sessions are safe and well-accepted by individuals with Down syndrome. No major negative effects were reported, supporting the safety of these programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of remote exercise and caregiver education for individuals with Down Syndrome because it offers a unique approach to improving quality of life. Unlike traditional therapies that often require in-person sessions, this treatment can be accessed from anywhere, reducing logistical barriers for caregivers and participants. Additionally, by empowering caregivers with education, the treatment could enhance long-term outcomes by ensuring consistent support and engagement in daily activities. This dual approach aims to provide a more holistic and accessible solution, potentially leading to improved physical and cognitive health for those with Down Syndrome.

What evidence suggests that remote exercise and caregiver education sessions are effective for older adults with Down syndrome?

Research has shown that remote exercise programs can benefit people with Down syndrome. One study found that participants improved their balance after a 12-week remote exercise program. Another study demonstrated that adults with Down syndrome could safely participate in exercise programs, potentially benefiting their health. Additionally, online exercise programs increase accessibility for individuals with intellectual disabilities, such as Down syndrome, enhancing their quality of life. This trial will evaluate the effectiveness of remote exercise combined with caregiver education for older adults with Down syndrome. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

Caregivers: Reports being a primary caregiver of an adult with DS

Caregivers: Age ≥18 yrs.

Caregivers: Self-reported ability to participate in physical activity

Exclusion Criteria

I have Down syndrome and heart, metabolic, or kidney problems or symptoms.

I have Down syndrome and cannot do moderate or vigorous exercise.

I have heart, metabolic, or kidney disease or related symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive remote-delivered functional exercise classes and dementia caregiving training sessions over 12 weeks

12 weeks

36 exercise sessions (remote), 12 caregiver training sessions (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Remote Exercise and Caregiver Education Sessions

How Is the Trial Designed?

Group I: Remote Exercise and Caregiver Education Experimental Treatment 2 Interventions

Single Arm with active intervention for remote exercise and caregiver education sessions

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6005664/

Remote Exercise for Adults with Down Syndrome - PMC - NIH

All participants completed the 12 week intervention, attended ~89% of group exercise and ~84% of support/education sessions, and averaged 28 ...

2.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1111/jir.70087

Outcomes of an Exercise Intervention in Adults With Down ...

Results from this analysis show preliminary support for young adults with DS and CHD to safely participate in exercise interventions that are ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04048759

NCT04048759 | The Promotion of Physical Activity for the ...

The objectives of this study are to determine the feasibility and potential efficacy of remotely delivered group exercise sessions to increase daily ...

4.

oasis.library.unlv.edu

oasis.library.unlv.edu/cgi/viewcontent.cgi?article=5563&context=thesesdissertations

Effects of a 12-week Remote Exercise Program on Balance in ...

A combined exercise program (walking, dynamic balance exercises, and plyometrics) was shown to be effective in improving balance in adults with ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2451865420300910

Rationale and design for a 12 Month randomized trial

Therefore, we will conduct a trial in 80 non-demented adults with DS to determine the feasibility and potential efficacy of remotely delivered group MVPA ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12893337/

Outcomes of an exercise intervention in adults with Down ...

This secondary analysis used data from a 12-month randomized controlled physical activity intervention for adults with DS. Safety of the ...

7.

researchgate.net

researchgate.net/publication/325949713_Remote_Exercise_for_Adults_with_Down_Syndrome

Remote Exercise for Adults with Down Syndrome

Participant retention (100%), attendance at both remote group exercise (≈85%) and support/education sessions (≈86%) observed in the current 12-month trial were ...