NCT06537648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

August 2, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2025

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 13, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

July 18, 2024

Results QC Date

January 22, 2026

Last Update Submit

March 12, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (2)

  • Energy Expenditure

    1 session

  • Exercise Intensity

    12 weeks

Study Arms (1)

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.

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

Interventions

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.

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

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Down SyndromeSedentary Behavior

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornBehavior

Limitations and Caveats

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.

Results Point of Contact

Title
Julianne G. Clina
Organization
University of Kansas Medical Center

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2024

First Posted

August 5, 2024

Study Start

August 2, 2024

Primary Completion

May 9, 2025

Study Completion

May 9, 2025

Last Updated

March 13, 2026

Results First Posted

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations