CompletedNot Applicable

The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome

United States81 participantsStarted 2020-01-21

Plain-language summary

The objectives of this study are to determine the feasibility and potential efficacy of remotely delivered group exercise sessions to increase daily moderate to vigorous physical activity in adults with Down syndrome, relative to a usual care control. Participants will be randomized to attend 40 min remotely delivered group moderate to vigorous physical activity (MVPA) sessions at low frequency (1 session/wk.,RL), high frequency (3 sessions/wk., RH), or usual care control usual care control (UC). In addition to the group MVPA sessions, participants in both the RL and RH groups will also receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. Content for both the RL and RH arms will be identical with the exception of group session frequency (1 vs. 3/wk.). Participants in the UC arm will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education).The primary aim is to Assess daily MVPA (min) in the RL, RH, and UC arms at baseline, 3, 6, 9, and 12 mos., and obtain effect sizes for change in MVPA over 12-mos.Secondary Aim 1 is to assess the impact of MVPA on cardiovascular fitness, quality of life, cognitive function, and brain parameters related to Alzheimer's Disease (whole and regional brain volume, functional connectivity, and cerebral blood flow) at baseline, 6, and 12 mos. Secondary Aim 2 will determine the feasibility (retention, session attendance, use of recorded sessions (RH/RL only) of RL, RH, and UC interventions.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age 18 and over. * Diagnosis of DS as determined by a Community Service Provider operating in our recruitment area under the auspices of a Community Developmental Disability Organization (CDDO). * Sufficient functional ability to understand directions, communicate preferences, wants and needs through spoken language. * Living at home with a parent/guardian or in a supported living environment with a caregiver who agrees to serve as a study partner. * No plans to relocate outside the study area over the next 12 mos. * Internet access in the home. Exclusion Criteria: * Diagnosis of dementia as determine by the Cambridge Examination for Mental Disorders of Older People with Down Syndrome and others with intellectual disabilities. * Unable to participate in MVPA. * Pregnancy during the previous 6 mos., currently lactating or planned pregnancy in the following 12 mos. * Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty as determined by the PCP. * Unwilling to be randomized. * Participation in a regular exercise program, i.e. greater than or equal to 20 min/d greater than or equal to 3 d/wk. * Contraindications for MRI, including metal implants or devices incompatible with MRI such as pacemakers, claustrophobia, and inability to lay in a supine position.

What they're measuring

Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day

Timeframe: Baseline to 12 months

Trial details

NCT IDNCT04048759

SponsorUniversity of Kansas Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-22

Results submitted2024-05-20