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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 12 weeks |
| Adverse Events | Adverse events will be collected on a weekly basis. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 session |
| Exercise Intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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All 20 participants who consented to participate in the program enrolled in the intervention. All enrolled participants were assigned to the single treatment arm. No participants were excluded between enrollment and assignment
Adults with DS were recruited to participate in a 12-week exercise intervention with two dance-based exercise sessions per week. Participants were recruited in two cohorts, with the goal of 10 participants per cohort. Cohorts were limited to 10 people to ensure the exercise instructor could safely observe all participants at the same time. Participants were recruited using flyers and emails to past research participants and through community partnerships.
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| ID | Title | Description |
|---|---|---|
| FG000 | Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome | Participants will be asked to attend 35 minute, remotely delivered, group exercise classes using choreographed exercise twice a week for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All 20 enrolled participants were assigned to the single treatment arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome | Participants will be asked to attend 35 minute, remotely delivered, group exercise classes using choreographed exercise twice a week for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All 20 participants enrolled were included in the analysis for attendance. | Posted | Mean | Full Range | Number of Classes Attended | 12 weeks |
|
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From enrollment to end of intervention, 12 weeks.
Safety was assessed via the number and type of adverse events during the intervention in accordance with the National Institute on Aging guidelines. This included the severity of the event (mild, moderate, severe), relatedness to intervention (not related, possibly related, definitely related) and if it was considered a Serious Adverse Event (resulting in death, hospitalization, medical event, or disability) .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome | Participants will be asked to attend 35 minute, remotely delivered, group exercise classes using choreographed exercise twice a week for 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory illness (common cold) | Infections and infestations | Non-systematic Assessment | Participant caught a respiratory virus and went to the doctor to get medication. This was classified as mild and not related to the intervention. |
The sample size was small (n = 20) and the program duration short (12 weeks), which limits generalizability and makes it unclear whether usability and outcomes would be sustained over longer interventions. The sample was also relatively young (mean age 28.3 years), and none required assistive devices for ambulation, potentially limiting applicability to older adults or those with additional mobility impairments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julianne G. Clina | University of Kansas Medical Center | 913-588-7982 | jclina@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2024 | Jan 21, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2025 | Feb 20, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
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. |
| 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Level of Support Needs | As reported by caregiver | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | 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. | All enrolled participants were assigned to the single treatment arm and were included in the analysis for retention. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Primary | Adverse Events | Adverse events will be collected on a weekly basis. | All enrolled participants were assigned to the single treatment arm and were included when totaling number and types of adverse events. | Posted | Number | Event Type | 12 weeks |
|
|
|
| Secondary | 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. | Out of the 20 participants enrolled, 16 were able to complete the energy expenditure assessment. Two attempted the assessment but were unable to complete the assessment per the protocol, and two were unable to be scheduled due to scheduling conflicts. | Posted | Mean | Standard Deviation | Metabolic Equivalents of Task | 1 session |
|
|
|
| Secondary | 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. | Of the 20 participants enrolled, only 16 were able to complete the assessment of exercise intensity. Two were unable to complete the study protocol as described due to non-compliance with the mask and two were unable to be scheduled to to schedule conflicts. | Posted | Mean | Full Range | Percent of class in moderate-to-vigorous | 12 weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 4 |
| 20 |
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| Foot pain from long walk earlier in day | Injury, poisoning and procedural complications | Non-systematic Assessment | Participant went for a long walk before class and had some foot pain during class. Class was modified to allow participant to use chair. Classified as mild and not related to intervention. |
|
| Back pain from previous injury | Injury, poisoning and procedural complications | Non-systematic Assessment | Participant had back pain from an existing injury and asked for modifications to exercise to prevent any pain resurgence. Modifications were provided. Considered mild and not related to intervention. |
|
| Knee pain from sporting event | Injury, poisoning and procedural complications | Non-systematic Assessment | Participant injured knee during a sporting activity outside of class and went to urgent care to get X-Rays. Participant was provided with alternative exercises. Considered Moderate severity; unrelated to intervention. |
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| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D001519 | Behavior |