Dance Exercise for Down Syndrome

(DANCE-DS Trial)

Overseen By Lauren Ptomey, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Cancer, Recent heart attack, Stroke, others

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

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a remote dance exercise program called "Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome Program" to determine its suitability for young adults with Down Syndrome. The goal is to assess whether this dance routine can improve fitness and brain health while remaining easy to follow online. Participants will join group dance classes twice a week for 12 weeks. The program is ideal for those with Down Syndrome who can communicate verbally, have internet access, and enjoy moderate exercise. As an unphased trial, this study provides a unique opportunity to explore innovative methods to enhance health and well-being.

Will I have to stop taking my current medications?

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 young adults with Down Syndrome?

Research has shown that exercise is generally safe and well-tolerated by people with Down syndrome. This trial involves remote dance sessions, which are non-invasive and carry no known serious risks. Previous studies on exercise have demonstrated positive outcomes, such as improved fitness and enhanced cognitive skills, with minimal negative effects. Given that this trial uses a dance exercise program, it is expected to be safe, with participants likely experiencing only mild side effects, such as temporary muscle soreness or fatigue. This aligns with the general understanding that physical activities, like dancing, are typically safe and beneficial for health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Dance Exercise for Down Syndrome program because it offers a fun and engaging way to potentially reduce Alzheimer's risk through choreographed dance routines. Unlike traditional treatments that might focus on medication or passive activities, this program involves active participation in 35-minute group exercise sessions conducted online, making it accessible and interactive. The unique approach combines physical activity with social engagement, which might offer cognitive benefits and improve the overall quality of life for participants with Down syndrome.

What evidence suggests that this dance exercise program is effective for Down Syndrome?

Research has shown that exercise might help delay Alzheimer's disease in the general population. This finding is encouraging for people with Down syndrome, who face a higher risk of developing Alzheimer's. Early findings suggest that dance exercises, which involve learning dance steps, can improve both fitness and cognitive skills. This type of exercise not only involves movement but also engages the brain. In this trial, participants will take part in the "Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome Program," which offers remotely delivered, group exercise classes. Although specific data for young adults with Down syndrome remains limited, exercise has been linked to better health outcomes in many groups. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for young adults with Down Syndrome who lead a sedentary lifestyle and are interested in participating in a remote exercise program. The goal is to see if this program can be done easily and if it's suitable for them.

Inclusion Criteria

Sufficient functional ability to communicate through spoken language

No plans to relocate outside the study area over the next 12 weeks

I have been diagnosed with Down syndrome.

Exclusion Criteria

I am not willing to participate in follow-up assessments.

I have a serious health condition like cancer, heart issues, or am pregnant.

This criterion seems to be incomplete. Could you provide more details?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week remotely delivered group dance intervention with two 35-minute sessions per week

12 weeks

24 sessions (virtual)

Follow-up

Participants are monitored for changes in aerobic fitness and cognitive function after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome Program

Trial Overview The study tests a 12-week online group dance program, where participants will have two 35-minute sessions each week. It aims to check the ease of doing the dance remotely, its impact on fitness and thinking skills, and how much energy it uses.

How Is the Trial Designed?

Group I: Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome Experimental Treatment 1 Intervention

Participants will be asked to play attend 35 minute, remotely delivered, group exercise classes using choreographed exercise twice a week for 12 weeks.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

A preliminary study showed that remotely delivered moderate-to-vigorous physical activity (MVPA) sessions for adults with Down Syndrome (DS) led to high attendance, increased MVPA during sessions, and improvements in cognitive function.

A new trial will assess the feasibility and efficacy of these remote MVPA sessions in 80 non-demented adults with DS, focusing on increasing daily MVPA and evaluating impacts on cardiovascular fitness, quality of life, and cognitive function related to Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The promotion of physical activity for the prevention of Alzheimer's disease in adults with Down Syndrome: Rationale and design for a 12 Month randomized trial. Ptomey, LT., Szabo-Reed, AN., Martin, LE., et al.[2023]

Regular moderate and high-intensity exercise in adults with Down syndrome is associated with a significant reduction in the risk of cognitive decline, with high-intensity exercise linked to an 87% reduced risk of decline in personality and behavior over two years.

Engaging in moderate intensity exercise was also associated with a 62% reduction in the risk of memory and orientation decline, suggesting that physical activity may serve as a protective measure against dementia in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association between Physical Activity and CAMDEX-DS Changes Prior to the Onset of Alzheimer's Disease in Down Syndrome. Pape, SE., Baksh, RA., Startin, C., et al.[2022]

A longitudinal study involving 24 individuals with early-stage Alzheimer's disease showed that participation in a structured exercise program significantly improved physical fitness, including aerobic capacity and strength, with highly significant gains in the six-minute walk test (p < .001).

The program also positively impacted mood and slowed cognitive decline, demonstrating that exercise combined with cognitive and social stimulation can provide meaningful benefits for individuals with Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Student-led exercise sessions yield significant fitness gains for Alzheimer's patients. Arkin, SM.[2022]

In a pilot study involving 38 elderly patients with metabolic syndrome, those who participated in dance exercise twice a week for 6 months showed significant improvements in cognitive function, particularly in verbal fluency and memory tasks, compared to a control group.

Despite the cognitive benefits observed, the dance exercise did not lead to significant changes in cardiometabolic risk factors such as body mass index or blood glucose levels, suggesting that the cognitive improvements may be independent of physical health metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dance exercise on cognitive function in elderly patients with metabolic syndrome: a pilot study. Kim, SH., Kim, M., Ahn, YB., et al.[2021]

In a study of 61 non-demented adults with Down syndrome, higher levels of moderate-to-vigorous physical activity were positively associated with better cognitive functioning, while more sedentary behavior was linked to poorer cognitive performance.

Physical activity was found to influence white matter integrity in the brain, suggesting that staying active may help promote healthier cognitive aging in individuals with Down syndrome, although it did not show a direct association with Alzheimer's disease pathology markers like amyloid-β and tau.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and cognitive and imaging biomarkers of Alzheimer's disease in down syndrome. Fleming, V., Piro-Gambetti, B., Patrick, A., et al.[2022]

A 16-week dance intervention significantly improved cognitive function, particularly memory performance, in older adults with cognitive impairment, while aerobic exercise did not show similar cognitive benefits.

Both dance and aerobic exercise led to a significant reduction in neuropsychiatric symptoms, indicating that both forms of physical activity can positively impact mental health in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of dance and aerobic exercise on cognition and neuropsychiatric symptoms in sedentary older adults with cognitive impairment. Ayari, S., Abellard, A., Sakrani, S., et al.[2023]

In a study of 71 adults with Down syndrome, higher engagement in moderate physical activity was linked to better memory performance, suggesting that physical activity may help preserve cognitive function in this population.

While greater hippocampal volume was associated with improved memory scores, it did not show a significant relationship with physical activity levels, indicating that while exercise benefits memory, it may not directly influence hippocampal size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity, memory function, and hippocampal volume in adults with Down syndrome. Peven, JC., Handen, BL., Laymon, CM., et al.[2023]

Regular exercise is crucial for preventive health care, especially for older adults, as it can reduce the risk of chronic illnesses and improve mood and cognitive function.

The RDAD program, a home health exercise and problem-solving intervention, has been shown to effectively decrease physical, psychological, and behavioral disabilities in individuals with dementia, highlighting the importance of making exercise accessible and enjoyable for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A home health care approach to exercise for persons with Alzheimer's disease. Logsdon, RG., McCurry, SM., Teri, L.[2019]

A 26-week supervised aerobic exercise program improved functional ability in individuals with early Alzheimer's disease, as evidenced by a significant gain in scores on the Disability Assessment for Dementia.

Increased cardiorespiratory fitness from the exercise was linked to better memory performance and less hippocampal atrophy, indicating that improving physical fitness may help support brain health in early Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial. Morris, JK., Vidoni, ED., Johnson, DK., et al.[2023]

A six-month dance-exercise intervention led to significant cortical thickening in brain regions associated with visual processing and motor skills in seniors, suggesting potential benefits for cognitive health.

Participants in the dance-exercise group showed subtle improvements in executive functions compared to those who maintained their usual lifestyle, indicating that engaging in physical activity can enhance cognitive abilities in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain structure changes in nondemented seniors after six-month dance-exercise intervention. Rektorova, I., Klobusiakova, P., Balazova, Z., et al.[2020]

In a pilot study involving 16 institutionalized older adults with Alzheimer's disease, the Biodanza intervention, which is a nonpharmacological dance movement therapy, significantly reduced agitation and neuropsychiatric behaviors.

The promising results suggest that Biodanza could be a beneficial therapeutic approach for improving the well-being of individuals with Alzheimer's, warranting further effectiveness studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biodanza as a Nonpharmacological Dance Movement-Based Treatment in Older People With Alzheimer's Disease: An Italian Pilot Study in 2 Tuscan Nursing Homes. Chiesi, F., Gori, E., Collini, F., et al.[2023]

A 12-month exercise program consisting of walking, strength, balance, and flexibility training significantly slowed the decline in the ability to perform activities of daily living (ADLs) in 134 patients with Alzheimer's disease compared to routine medical care.

The exercise program also improved physical performance, as evidenced by better 6-meter walking speed, with no adverse effects reported, highlighting its safety and potential benefits for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise program for nursing home residents with Alzheimer's disease: a 1-year randomized, controlled trial. Rolland, Y., Pillard, F., Klapouszczak, A., et al.[2022]

Dance interventions, including various styles and dance therapy, have been shown to improve physical and psychological health in elderly populations (65 years and older) and children, with benefits in areas such as depression, cognitive function, and neuromotor skills.

Notably, dance was associated with increased brain volume and function, as well as enhanced neurotrophic growth factors, suggesting that dance can have significant positive effects on brain health compared to regular exercise alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dance Is a Healing Art. Cox, L., Youmans-Jones, J.[2023]

The 4-month BAILAMOS dance program did not result in significant changes in hippocampal volume, indicating that it may not reverse hippocampal atrophy associated with cognitive decline.

Participants in the dance program reported increased physical activity compared to the control group, suggesting that while the program may not affect hippocampal size, it can enhance overall activity levels in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of the BAILAMOS Dance Program on hippocampal volume in older Latinos: a randomized controlled pilot study. Guzman, J., Aguiñaga, S., Balbim, GM., et al.[2022]

A 12-week exercise intervention involving group sessions improved memory performance in adults with Down syndrome, suggesting that physical activity can positively impact cognitive function.

Participants who attended more frequent exercise sessions (2 times a week) engaged in significantly more physical activity, which correlated with better cognitive outcomes, highlighting the importance of exercise frequency for cognitive benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in cognitive function after a 12-week exercise intervention in adults with Down syndrome. Ptomey, LT., Szabo, AN., Willis, EA., et al.[2023]

Citations

1. ctv.veeva.com ctv.veeva.com/study/decreasing-alzheimers-risk-through-online-choreographed-exercise-down-syndrome

Decreasing Alzheimer's Risk Through oNline Choreographed ... The investigators are assessing acceptability, appropriateness, and feasibility of an remote choreographed exercise intervention using ...

2. trial.medpath.com trial.medpath.com/clinical-trial/702f2979ad386e31/nct06537648-decreasing-alzheimers-risk-online-choreographed-exercise-down-syndrome

Decreasing Alzheimer's Risk Through oNline Choreographed ... The investigators are assessing acceptability, appropriateness, and feasibility of an remote choreographed exercise intervention using validated scales ...

3. clinconnect.io clinconnect.io/trials/NCT06537648

Decreasing Alzheimer's Risk Through oNline Choreographed This clinical trial is looking at a fun and engaging way to help young adults with Down syndrome stay active and possibly improve their fitness and thinking ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12162260/

Results from a 12‐month randomized trial - PMC Evidence suggests that exercise may delay Alzheimer's disease (AD) in the general population, but its impact on adults with Down syndrome (DS) ...

5. go.drugbank.com go.drugbank.com/conditions/DBCOND0061020

Down Syndrome (DS) (DBCOND0061020) Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome, No drug interventions, prevention, Not Available, completed. NCT06748248.