NCT04048759Completed
The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome
Source: ClinicalTrials.gov · Last updated 23 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 81 (actual)
- First submitted
- 5 Aug 2019
- Start date
- 21 Jan 2020
- Primary completion date
- 22 Nov 2023
- Lead sponsor
- University of Kansas Medical Center
- Diseases
- Alzheimer disease
- NCT number
- NCT04048759
What you commit to
- Study type: Interventional
- Participants enrolled: 81
- From 21 Jan 2020 to the primary completion date, 22 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnancy during the previous 6 mos., currently lactating or planned pregnancy in the following 12 mos.
- Contraindications for MRI, including metal implants or devices incompatible with MRI such as pacemakers, claustrophobia, and inability to lay in a supine position.
Other illness
- Diagnosis of dementia as determine by the Cambridge Examination for Mental Disorders of Older People with Down Syndrome and others with intellectual disabilities.
- Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty as determined by the PCP.
Other
- Unable to participate in MVPA.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
Related publications
- The impact of a 12-month randomized exercise intervention on cognitive function and brain volume in adults with down syndrome.Disabil Health J · 2026 · PMID 42532804
This page is information, not medical advice. Discuss any trial with your doctor.