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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06537648
Acronym
DANCE-DS
Enrollment
20
Registered
2024-08-05
Start date
2024-08-02
Completion date
2025-05-09
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome, Physical Inactivity

Brief 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. 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.

Interventions

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

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.

Sponsors

University of Kansas Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Attendance12 weeksAttendance 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).
Retention12 weeksParticipant 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 Events12 weeksAdverse events will be collected on a weekly basis.

Secondary

MeasureTime frameDescription
Energy Expenditure1 sessionEnergy 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.
Exercise Intensity12 weeksExercise 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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

Baseline characteristics

Characteristic
Age, Continuous28.3 years
STANDARD_DEVIATION 8
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Level of Support Needs
Mild
13 Participants
Level of Support Needs
Moderate
7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
16 Participants
Sex: Female, Male
Female
14 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 20
other
Total, other adverse events
4 / 20
serious
Total, serious adverse events
0 / 20

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026