N/A
N=81
The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome
Down Syndrome · Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT04048759 ↗Enrolled (actual)
81
Serious AEs
7.4%
Results posted
Jul 2024
Primary outcome: Primary: Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day — 13.8; 17.9; 15.6; 21.8 min of MVPA/day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Remote Low (Behavioral); Remote High (Behavioral); Personal Coach (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day |
13.8; 17.9; 15.6; 21.8; 13.8; 19.9 | — |
| SECONDARY Cognitive Function |
— | — |
| SECONDARY Cardiovascular Fitness |
— | — |
| SECONDARY Change in Quality of Life |
— | — |
| SECONDARY Brain Volume |
— | — |
| SECONDARY Functional Connectivity |
— | — |
| SECONDARY Cerebral Blood Flow |
— | — |
| SECONDARY Retention |
— | — |
| SECONDARY Session Attendance |
— | — |
| SECONDARY Use of Recorded Exercise Sessions |
— | — |
| SECONDARY Reported Serious Adverse Event |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04048759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.