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NCT04048759 · ClinicalTrials.gov registry record · NA
The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome
A NA study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 81
- Enrollment target
NCT04048759 is a NA study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 81 participants.
The verdict
NCT04048759, a NA study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 81 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Remote Low
- BEHAVIORAL Remote High
- BEHAVIORAL Personal Coach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2020-01-21 |
| Est. Completion | 2023-11-22 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04048759
The ClinicalTrials.gov registry entry for NCT04048759 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Remote Low is the first listed.
NCT04048759 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04048759 about?
NCT04048759 is a clinical study titled "The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome". 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...
What is the current status of trial NCT04048759?
This trial is currently completed. It is a NA study. The enrollment target is 81 participants. The study started on 2020-01-21. Estimated completion is 2023-11-22.
What interventions are being tested in trial NCT04048759?
The interventions under investigation include: Remote Low (BEHAVIORAL), Remote High (BEHAVIORAL), Personal Coach (BEHAVIORAL).
Who is sponsoring clinical trial NCT04048759?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
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