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NCT04048759

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

Completed NA Results posted Last updated 23 July 2024
What this trial tests

NA trial testing Remote Low in Down Syndrome in 81 participants. Completed in 22 November 2023.

Timeline
21 January 2020
Primary endpoint
22 November 2023
22 November 2023

Quick facts

Lead sponsorUniversity of Kansas Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment81
Start date21 January 2020
Primary completion22 November 2023
Estimated completion22 November 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Kansas Medical Center

Who can join

18 and older, any sex, with Down Syndrome or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day Primary · Baseline to 12 months

MVPA was assessed using an ActiGraph tri-axial accelerometer.

Absolute MVPA at Baseline
GroupValue95% CI
Remote High13.8± 13.9
Remote Low17.9± 29.6
Personal Coach15.6± 15.8
Absolute MVPA at 3 months
GroupValue95% CI
Remote High21.8± 19.3
Remote Low13.8± 12.6
Personal Coach19.9± 18.3
Absolute MVPA at 6 months
GroupValue95% CI
Remote High26.1± 24.4
Remote Low15.9± 15.7
Personal Coach20.0± 18.6
Absolute MVPA at 9 months
GroupValue95% CI
Remote High23.9± 21.4
Remote Low19.5± 24.9
Personal Coach17.9± 17.0
Absolute MVPA at 12 months
GroupValue95% CI
Remote High24.4± 23.5
Remote Low14.7± 16.7
Personal Coach17.0± 13.9

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Remote High
Serious: 2/34 (6%)
Deaths: 0/34
Remote Low
Serious: 3/32 (9%)
Deaths: 0/32
Personal Coach
Serious: 1/15 (7%)
Deaths: 0/15

Serious adverse events (6 terms)

ReactionSystemRemote HighRemote LowPersonal Coach
CholecystectomyGastrointestinal disorders
Mitral Valve RegurgitationCardiac disorders
Pulmonary edemaRespiratory, thoracic and mediastinal disorders
AppendectomyImmune system disorders
Spinal infectionInfections and infestations
Isthmic SpondylolisthesisMusculoskeletal and connective tissue disorders
Other adverse events (5 terms — click to expand)

ReactionSystemRemote HighRemote LowPersonal Coach
Ankle InjuryMusculoskeletal and connective tissue disorders
COVID-19 InfectionInfections and infestations
Abdominal painGastrointestinal disorders
Back painMusculoskeletal and connective tissue disorders
Gastritis and gastroparesisGastrointestinal disorders

Most-reported serious reactions: Cholecystectomy, Mitral Valve Regurgitation, Pulmonary edema, Appendectomy, Spinal infection, Isthmic Spondylolisthesis.

Data from ClinicalTrials.gov NCT04048759 adverse events section.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The promotion of physical activity for the prevention of Alzheimer's disease in adults with Down Syndrome: Rationale and design for a 12 Month randomized trial.
    Ptomey LT, Szabo-Reed AN, Martin LE, Mayo MS, et al · · 2020 · cited 18× · PMID 32642594 · DOI 10.1016/j.conctc.2020.100607
  2. The association of increased body mass index on cardiorespiratory fitness, physical activity, and cognition in adults with down syndrome.
    Dodd D, Helsel B, Bodde AE, Danon JC, et al · · 2023 · cited 8× · PMID 37407386 · DOI 10.1016/j.dhjo.2023.101497
  3. The association between cardiovascular health and cognition in adults with Down syndrome.
    Frank L, Helsel B, Dodd D, Bodde AE, et al · · 2023 · cited 4× · PMID 38057709 · DOI 10.1186/s11689-023-09510-z
  4. Charting the future: current and future directions in translational research for individuals with Down syndrome.
    Waugh KA, Wilkins HM, Smith KP, Ptomey LT. · · 2025 · cited 1× · PMID 40629284 · DOI 10.1186/s11689-025-09630-8
  5. The promotion of physical activity for use in Alzheimer's disease prevention trials in adults with Down syndrome: Results from a 12-month randomized trial.
    Ptomey LT, Helsel BC, Washburn RA, Montgomery RN, et al · · 2025 · cited 1× · PMID 40520478 · DOI 10.1002/trc2.70115
  6. Outcomes of an Exercise Intervention in Adults With Down Syndrome and Congenital Heart Disease: A Secondary Analysis.
    Clina JG, Helsel BC, White DA, Sherman JR, et al · · 2026 · PMID 41633577 · DOI 10.1111/jir.70087
  7. Successful Online Exercise Intervention Studies for Individuals With Intellectual Disabilities Including Down Syndrome: Best Practices and Recommendations.
    Hilgenkamp T, Bodde A, Mann S, Helsel B, et al · · 2025 · PMID 40492527 · DOI 10.1111/jar.70080

Verify or expand the search:

Other recruiting trials for Down Syndrome

Currently open trials in the same condition.

Other University of Kansas Medical Center trials

Trials by the same sponsor.

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