CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 81 enrolled
Drug / intervention
Remote Low +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04048759
NCT04048759N/ACompleted

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

University of Kansas Medical Center·interventional·Posted Aug 7, 2019·Updated Jul 23, 2024

In Brief

A clinical study evaluating Remote Low, Remote High, and 1 other intervention for Down Syndrome and Alzheimer Disease. Completed, enrolled 81 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 7, 2019
Enrollment StartJan 21, 2020
Primary CompletionNov 22, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.9 years ago

Interventions

Remote Lowbehavioral

Participants will attend 40 min remotely delivered group MVPA sessions once a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk.

Remote Highbehavioral

Participants will attend 40 min remotely delivered group MVPA sessions 3x a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk.

Personal Coachbehavioral

Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education.