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

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ClinicalTrials.gov Identifier: NCT04048759
Recruitment Status : Not yet recruiting
First Posted : August 7, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Down Syndrome Alzheimer Disease Behavioral: Remote Low Behavioral: Remote High Behavioral: Personal Coach Not Applicable

Detailed Description:
This research study will compare 3 strategies for the delivery of an intervention to increase moderate to vigorous physical activity (MVPA) in community dwelling adults with Down Syndrome; remotely delivered group MVPA sessions at low (1 session/wk.,RL), high frequency (3 sessions/wk., RH), or usual care control (UC). Adults (age ≥ 18 yrs.) with Down Syndrome will be randomized (2:2:1) to one of the 3 intervention arms for an 12-mo. trial. Cohorts of ~20 adults with Down Syndrome will be recruited and computer randomized. Participants will be stratified by sex and sequentially randomized by the study statistician. Participants in all arms will be provided with an iPad for intervention delivery, Fitbit for self-monitoring MPA, and will be asked to complete 150 min of MPA/wk. Participants in the RL and RH arms will be asked to complete 40 minutes MVPA sessions delivered via Zoom software on an iPad, RL will be provided 1 session/wk, and RH will be provided 3 sessions/wk. Participants in both the RL and RH groups will also receive one 20-min remotely delivered individual support/education session/wk. with a heath coach to discuss progress and provide support. The UC intervention will follow the traditional approach to promote increased MVPA. Participants will receive an iPad tablet loaded with information regarding increasing MVPA and will also receive resistance bands and a Fitbit for self-monitoring MVPA. Monthly 20-min. education/support sessions, identical to the education/support sessions provided in the RL and RH arms, will be delivered to participants and their caregivers remotely on the iPad using FaceTime. All outcomes will be collected by trained research assistants who are blinded to the study condition. The primary outcome, daily MVPA (min) in the RL, RH, and UC arms will be assessed at baseline, 3, 6, 9, and 12 mos. using an accelerometer. All secondary outcomes will be assessed at baselines, 6, and 12 months. Secondary outcomes are to assess the impact of MVPA across the RL, RH, and UC arms on cardiovascular fitness, quality of life, cognitive function and brain parameters related to Alzheimer's Disease (whole and regional brain volume, functional connectivity, cerebral blood flow). Additionally the researchers will determine the feasibility (retention, session attendance, use of recorded sessions (RH/RL only) and safety of RL, RH, and UC arms.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024


Arm Intervention/treatment
Remote Low Behavioral: Remote Low
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 High Behavioral: Remote High
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 Coach Behavioral: Personal Coach
Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education.




Primary Outcome Measures :
  1. Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: Baseline to 12 months ]
    MVPA will be assessed at baseline (month 0), 3, 6, 9, and, 12 months, using an ActiGraph tri-axial accelerometer


Secondary Outcome Measures :
  1. Cognitive Function [ Time Frame: Baseline to 12 months ]
    Working memory, processing speed, multitasking, and episodic memory will be assessed at baseline, 6 and, and 12 months, using tests selected from the widely used Cambridge Neuropsychological Test Automated Battery (CANTAB, Cambridge Cognition, LTD, Cambridge, UK) for Down syndrome. The CANTAB for Down syndrome uses a battery of tests including multitasking, episodic memory, executive function and processing speed.

  2. Cardiovascular fitness [ Time Frame: Baseline to 12 months ]
    Maximal treadmill tests (modified Balke protocol) will be completed at baseline, 6, and 12 months

  3. Change in Quality of Life [ Time Frame: Baseline to 12 months ]
    Quality of life will be assessed at baseline, 6, and 12 months with the Personal Well-Being Index Intellectual Disability, which contains 7 items, each corresponding to a quality of life domain: standard of living, health, life achievement, personal relationships, personal safety, community connectedness, and future security. Participants answer questions on a 0-4 scale, with 0 being least happy and 4 being most happy.

  4. Brain volume [ Time Frame: Baseline to 12 months ]
    Brain volume will be measured using structural MRI at baseline, 6, and 12 months

  5. Functional connectivity [ Time Frame: Baseline to 12 months ]
    Functional connectivity will be measured using resting state MRI (rsMRI) at baseline, 6, and 12 months.

  6. Cerebral blood flow [ Time Frame: Baseline to 12 months ]
    Functional connectivity will be measured using arterial spin labeling at baseline, 6, and 12 months

  7. Retention [ Time Frame: Baseline to 12 months ]
    Retention will be measured by the percentage of participants who complete the 12 month intervention, defined as completing the 12 month outcome assessments.

  8. Session attendance [ Time Frame: Baseline to 12 months ]
    Session attendance for both group MVPA and education/support sessions from baseline to 12 months will be obtained from records maintained by the health educator, and expressed as the percent of possible sessions. Attendance at group MVPA sessions will be defined as being logged in to the video conference and remaining on the screen for the entire 30-min session. Attendance at individual support/education sessions, for the both exercise and UC conditions, will be defined as answering the FaceTime call, and being present on screen for the entire session.

  9. Use of recorded exercise sessions [ Time Frame: Baseline to 12 months ]
    Use of recorded exercise sessions will be tracked using Dropbox which provides information on how many times each user watched a video.

  10. Reported Serious adverse event [ Time Frame: Baseline to 12 months ]
    Safety will be measured by number of participants reporting a serious adverse event, i.e., any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or results in persistent or significant disability/incapacity.


Other Outcome Measures:
  1. Weight [ Time Frame: Baseline to 12 months ]
    Weight will be measured in light clothing on a calibrated scale (Model #PS6600, Belfour, Saukville, WI) to the nearest 0.1 kg.

  2. Height [ Time Frame: Baseline to 12 months ]
    Standing height will be measured with a portable stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK).

  3. Waist Circumference [ Time Frame: Baseline to 12 months ]
    Waist circumference will be assessed using a waist tape measure.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048759


Contacts
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Contact: Lauren Ptomey, PhD 9135887983 lptomey@kumc.edu

Sponsors and Collaborators
University of Kansas Medical Center
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Lauren Ptomey, PhD University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT04048759     History of Changes
Other Study ID Numbers: STUDY00143836
R01AG063909 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Kansas Medical Center:
Physical Activity
Exercise

Additional relevant MeSH terms:
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Syndrome
Alzheimer Disease
Down Syndrome
Disease
Pathologic Processes
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn