Down SyndromeDANCE-DSNCT06537648
Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
A study testing Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome Program in people with Down Syndrome and Physical Inactivity, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The investigators are assessing acceptability, appropriateness, and feasibility of an remote choreographed exercise intervention using validated scales alongside qualitative data among young adults with Down Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Down Syndrome, Physical Inactivity
- What is being tested?
- Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2024to 9 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Down syndrome
- Sufficient functional ability to communicate through spoken language
- No plans to relocate outside the study area over the next 12 weeks
- Possession of a personal device that allows for connectivity to the internet and participate in 2x weekly group video calls
- Ability to participate in Moderate to vigorous physical activity
Who cannot join
- Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty as determined by the research staff
- unwilling to participate in outcomes assessments
- uninterested
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The investigators are assessing acceptability, appropriateness, and feasibility of an remote choreographed exercise intervention using validated scales alongside qualitative data among young adults with Down Syndrome. Participants will take part in a 12-week exercise program with two 35-minute session per week delivered in a group setting. The aims of the project are to:
- Assess the feasibility of a 12 week remotely delivered group dance intervention.
- Assess changes in aerobic fitness and cognitive function in response to a 12 week remotely delivered group dance intervention.
- Assess the intensity and total energy expenditure of remotely delivered group dance sessions.
Read the detailed description
The incidence of Alzheimer's disease for persons with Down syndrome exceeds 90%, and physical activity engagement has demonstrated potential to delay onset of Alzheimer's disease for this population. Adults with Down syndrome participate in less physical activity than their counterparts without disability, partially due to unique barriers preventing engagement in typical modalities of physical activity for this population. Dance, which is characterized by rhythmic physical movements offers the potential for social engagement, and stimulation of brain functions may offer a reasonable alternative to traditional physical activity modalities. However, empirical evidence to support the feasibility of a remotely delivered group dance intervention and evaluation of the intensity and energy expenditure achieved by a dance intervention for adults with Down syndrome are currently unavailable and will be the focus of the proposed pilot trial. Adults with Down will be asked to attend 35 minute remotely delivered (Zoom®) group dance sessions twice weekly across 12 weeks to assess the acceptability, appropriateness, and feasibility of the intervention, energy expenditure achieved during the exercise sessions, and evaluate change in aerobic fitness and cognitive function after 12 weeks.
- Conditions
- Down Syndrome, Physical Inactivity
- Being tested
- Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome Program
- Medical subject headings
- Down Syndrome, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome ProgramBehavioural
Adults with Down syndrome will be asked to attend 35 minute, remotely delivered (Zoom®) group dance sessions twice weekly across 12 weeks. All sessions will be directed by an instructor experienced in leading 35 minute, group remote exercise sessions for individuals with intellectual disability as part of the ongoing exercise program for individuals with intellectual disability offered by the Division for Physical Activity and Weight Management.
| Study group | Role | What they receive |
|---|---|---|
| Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome | Experimental | Participants will be asked to attend 35 minute, remotely delivered, group exercise classes using choreographed exercise twice a week for 12 weeks. Receives: Behavioral: Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance
Attendance at each 35-minute online exercise classes will be collected. Attendance will be assessed as the number of sessions attended out of the total number of sessions available (24 sessions available).
Measured: 12 weeks
Retention
Participant retention will be collected based on the number of participants who complete the 12 week intervention. A total of up to 20 participants will be enrolled into the study. Participants that complete the 12-week intervention will be considered retained. Any participant that discontinues participation prior to the end of the 12-week intervention will not be considered retained.
Measured: 12 weeks
Adverse Events
Adverse events will be collected on a weekly basis.
Measured: 12 weeks
Secondary outcomes (2)
Energy Expenditure
Energy expenditure during a dance session (kilocalories per minute; Metabolic equivalents (METs) will be assessed by portable indirect calorimetry. Measurement was taken during one class session per participant, between weeks 4-12 of the 12 week intervention.
Measured: 1 session
Exercise Intensity
Exercise intensity will be assessed as an average of the percent of age-estimated maximal heart rate achieved during dance sessions assessed time spent in moderate to vigorous intensity as defined by the COSMED device.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start2 Aug 2024
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537648
- Sponsor's protocol ID
- T32AG078114
- Acronym
- DANCE-DS
- Status last verified
- Mar 2026
- First submitted
- 18 Jul 2024
- Last updated
- 13 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
- ClinicalTrials.gov ID
- NCT06537648
- Acronym / sponsor ID
- DANCE-DS / T32AG078114
- Conditions
- Down Syndrome, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Posted 13 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are assessing acceptability, appropriateness, and feasibility of an remote choreographed exercise intervention using validated scales alongside qualitative data among young adults with Down Syndrome. Participants will take part in a 12-week exercise program with two 35-minute session per week delivered in a group setting. The aims of the project are to:
- Assess the feasibility of a 12 week remotely delivered group dance intervention.
- Assess changes in aerobic fitness and cognitive function in response to a 12 week remotely delivered group dance intervention.
- Assess the intensity and total energy expenditure of remotely delivered group dance sessions.
Detailed description
The incidence of Alzheimer's disease for persons with Down syndrome exceeds 90%, and physical activity engagement has demonstrated potential to delay onset of Alzheimer's disease for this population. Adults with Down syndrome participate in less physical activity than their counterparts without disability, partially due to unique barriers preventing engagement in typical modalities of physical activity for this population. Dance, which is characterized by rhythmic physical movements offers the potential for social engagement, and stimulation of brain functions may offer a reasonable alternative to traditional physical activity modalities. However, empirical evidence to support the feasibility of a remotely delivered group dance intervention and evaluation of the intensity and energy expenditure achieved by a dance intervention for adults with Down syndrome are currently unavailable and will be the focus of the proposed pilot trial. Adults with Down will be asked to attend 35 minute remotely delivered (Zoom®) group dance sessions twice weekly across 12 weeks to assess the acceptability, appropriateness, and feasibility of the intervention, energy expenditure achieved during the exercise sessions, and evaluate change in aerobic fitness and cognitive function after 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome | Experimental | Behavioral: Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome ProgramParticipants will be asked to attend 35 minute, remotely delivered, group exercise classes using choreographed exercise twice a week for 12 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of Down syndrome
- Sufficient functional ability to communicate through spoken language
- No plans to relocate outside the study area over the next 12 weeks
- Possession of a personal device that allows for connectivity to the internet and participate in 2x weekly group video calls
- Ability to participate in Moderate to vigorous physical activity
Key exclusion criteria (3 listed)
- Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty as determined by the research staff
- unwilling to participate in outcomes assessments
- uninterested
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome ProgramAdults with Down syndrome will be asked to attend 35 minute, remotely delivered (Zoom®) group dance sessions twice weekly across 12 weeks. All sessions will be directed by an instructor experienced in leading 35 minute, group remote exercise sessions for individuals with intellectual disability as part of the ongoing exercise program for individuals with intellectual disability offered by the Division for Physical Activity and Weight Management. | Behavioural | Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome |
Primary outcome
Attendance
Time frame: 12 weeks
Attendance at each 35-minute online exercise classes will be collected. Attendance will be assessed as the number of sessions attended out of the total number of sessions available (24 sessions available).
Retention
Time frame: 12 weeks
Participant retention will be collected based on the number of participants who complete the 12 week intervention. A total of up to 20 participants will be enrolled into the study. Participants that complete the 12-week intervention will be considered retained. Any participant that discontinues participation prior to the end of the 12-week intervention will not be considered retained.
Adverse Events
Time frame: 12 weeks
Adverse events will be collected on a weekly basis.
2 secondary outcomes
Energy Expenditure
Time frame: 1 session
Exercise Intensity
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Down Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome Program in people with Down Syndrome and Physical Inactivity, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.