Trial Outcomes & Findings for Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome (NCT NCT06537648)
NCT ID: NCT06537648
Last Updated: 2026-03-13
Results Overview
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).
COMPLETED
NA
20 participants
12 weeks
2026-03-13
Participant Flow
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.
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
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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20
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|
Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
Baseline characteristics by cohort
| Measure |
Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
n=20 Participants
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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|---|---|
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Age, Continuous
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28.3 years
STANDARD_DEVIATION 8.0 • n=41 Participants
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Sex: Female, Male
Female
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14 Participants
n=41 Participants
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Sex: Female, Male
Male
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6 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=41 Participants
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
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1 Participants
n=41 Participants
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Race (NIH/OMB)
White
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16 Participants
n=41 Participants
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|
Race (NIH/OMB)
More than one race
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2 Participants
n=41 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=41 Participants
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|
Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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18 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=41 Participants
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Level of Support Needs
Mild
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13 Participants
n=41 Participants
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Level of Support Needs
Moderate
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7 Participants
n=41 Participants
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PRIMARY outcome
Timeframe: 12 weeksPopulation: All 20 participants enrolled were included in the analysis for 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).
Outcome measures
| Measure |
Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
n=20 Participants
Participants will be asked to play attend 35 minute, remotely delivered, group exercise classes using choreographed exercise twice a week for 12 weeks.
|
|---|---|
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Attendance
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21.7 Number of Classes Attended
Interval 16.0 to 24.0
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PRIMARY outcome
Timeframe: 12 weeksPopulation: All enrolled participants were assigned to the single treatment arm and were included in the analysis for 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.
Outcome measures
| Measure |
Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
n=20 Participants
Participants will be asked to play attend 35 minute, remotely delivered, group exercise classes using choreographed exercise twice a week for 12 weeks.
|
|---|---|
|
Retention
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20 Participants
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PRIMARY outcome
Timeframe: 12 weeksPopulation: All enrolled participants were assigned to the single treatment arm and were included when totaling number and types of adverse events.
Adverse events will be collected on a weekly basis.
Outcome measures
| Measure |
Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
n=20 Participants
Participants will be asked to play attend 35 minute, remotely delivered, group exercise classes using choreographed exercise twice a week for 12 weeks.
|
|---|---|
|
Adverse Events
Moderate
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1 Event Type
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Adverse Events
Mild
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3 Event Type
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SECONDARY outcome
Timeframe: 1 sessionPopulation: 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.
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.
Outcome measures
| Measure |
Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
n=16 Participants
Participants will be asked to play attend 35 minute, remotely delivered, group exercise classes using choreographed exercise twice a week for 12 weeks.
|
|---|---|
|
Energy Expenditure
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4.8 Metabolic Equivalents of Task
Standard Deviation 1.0
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SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
n=16 Participants
Participants will be asked to play attend 35 minute, remotely delivered, group exercise classes using choreographed exercise twice a week for 12 weeks.
|
|---|---|
|
Exercise Intensity
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90.1 Percent of class in moderate-to-vigorous
Interval 31.3 to 100.0
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Adverse Events
Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
n=20 participants at risk
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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|---|---|
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Infections and infestations
Respiratory illness (common cold)
|
5.0%
1/20 • 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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Injury, poisoning and procedural complications
Foot pain from long walk earlier in day
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5.0%
1/20 • 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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Injury, poisoning and procedural complications
Back pain from previous injury
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5.0%
1/20 • 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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|
Injury, poisoning and procedural complications
Knee pain from sporting event
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5.0%
1/20 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place