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

NCT04048759 | Completed Results

• 2 other identifiers: STUDY00143836R01AG063909
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Down Syndrome; Alzheimer Disease

Keywords

Physical Activity; Exercise

Outcome Measures

Primary Outcomes (1)

• Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day

  MVPA was assessed using an ActiGraph tri-axial accelerometer.

  Baseline to 12 months

Secondary Outcomes (10)

• Cognitive Function

  Baseline to 12 months

• Cardiovascular Fitness

  Baseline to 12 months

• Change in Quality of Life

  Baseline to 12 months

• Brain Volume

  Baseline to 12 months

• Functional Connectivity

  Baseline to 12 months

Other Outcomes (11)

• Weight

  Baseline to 12 months

• Height

  Baseline to 12 months

• Waist Circumference

  Baseline to 12 months

Study Arms (3)

Remote Low

OTHER

Behavioral: Remote Low

Remote High

OTHER

Behavioral: Remote High

Personal Coach

OTHER

Behavioral: Personal Coach

Interventions

Remote Low BEHAVIORAL

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 Low

Remote High BEHAVIORAL

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.

Remote High

Personal Coach BEHAVIORAL

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

Personal Coach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (4)

• Ptomey LT, Helsel BC, Washburn RA, Montgomery RN, Krebill R, Danon JC, Sherman JR, Forsha D, Bodde A, Szabo-Reed AN, Gorczyca AM, Donnelly JE. 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. Alzheimers Dement (N Y). 2025 Jun 12;11(2):e70115. doi: 10.1002/trc2.70115. eCollection 2025 Apr-Jun.

  PMID: 40520478 DERIVED

• Frank L, Helsel B, Dodd D, Bodde AE, Danon JC, Sherman JR, Forsha DE, Szabo-Reed A, Washburn RA, Donnelly JE, Ptomey LT. The association between cardiovascular health and cognition in adults with Down syndrome. J Neurodev Disord. 2023 Dec 6;15(1):43. doi: 10.1186/s11689-023-09510-z.

  PMID: 38057709 DERIVED

• Dodd D, Helsel B, Bodde AE, Danon JC, Sherman JR, Donnelly JE, Washburn RA, Ptomey LT. The association of increased body mass index on cardiorespiratory fitness, physical activity, and cognition in adults with down syndrome. Disabil Health J. 2023 Oct;16(4):101497. doi: 10.1016/j.dhjo.2023.101497. Epub 2023 Jun 16.

  PMID: 37407386 DERIVED

• Ptomey LT, Szabo-Reed AN, Martin LE, Mayo MS, Washburn RA, Gorczyca AM, Lepping RJ, Lee P, Forsha DE, Sherman JR, Danon JC, Donnelly JE. 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. Contemp Clin Trials Commun. 2020 Jun 30;19:100607. doi: 10.1016/j.conctc.2020.100607. eCollection 2020 Sep.

  PMID: 32642594 DERIVED

MeSH Terms

Conditions

Down Syndrome; Alzheimer Disease; Motor Activity

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Dr. Lauren Ptomey
• Organization: University of Kansas Medical Center

lptomey@kumc.edu

913-588-7983

Study Officials

• Lauren Ptomey, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 7, 2019
• Study Start: January 21, 2020
• Primary Completion: November 22, 2023
• Study Completion: November 22, 2023
• Last Updated: July 23, 2024
• Results First Posted: July 23, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)