Clinical trial NCT06537648: Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
Official title: Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Physical Inactivity
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Attendance
timeFrame: 12 weeks
measure: Retention
timeFrame: 12 weeks
measure: Adverse Events
timeFrame: 12 weeks
Secondary outcomes:
measure: 6-minute walk test
timeFrame: 12 weeks
measure: Episodic Memory
timeFrame: 12 weeks
measure: Energy Expenditure
timeFrame: 1 session
measure: Exercise intensity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University Of Kansas Medical Center
state: Kansas
Study officials:
References: