Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04048759
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE August 5, 2019
First Posted Date  ICMJE August 7, 2019
Last Update Posted Date January 23, 2020
Actual Study Start Date  ICMJE January 21, 2020
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: Baseline to 12 mos ]
MVPA will be assessed at baseline (mo. 0), 3, 6, 9, and, 12 mos., using an ActiGraph tri-axial accelerometer
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • 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.
  • Cardiovascular fitness [ Time Frame: Baseline to 12 months ]
    Maximal treadmill tests (modified Balke protocol) will be completed at baseline, 6, and 12 months
  • 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.
  • Brain volume [ Time Frame: Baseline to 12 months ]
    Brain volume will be measured using structural MRI at baseline, 6, and 12 months
  • Functional connectivity [ Time Frame: Baseline to 12 months ]
    Functional connectivity will be measured using resting state MRI (rsMRI) at baseline, 6, and 12 months.
  • Cerebral blood flow [ Time Frame: Baseline to 12 months ]
    Functional connectivity will be measured using arterial spin labeling at baseline, 6, and 12 months
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
  • Cognitive Function [ Time Frame: Baseline to 12 mos. ]
    Working memory, processing speed, multitasking, and episodic memory will be assessed at baseline, 6 and, and 12 mos., 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.
  • Cardiovascular fitness [ Time Frame: Baseline to 12 mos ]
    Maximal treadmill tests (modified Balke protocol) will be completed at baseline, 6, and 12 mos.
  • Change in Quality of Life [ Time Frame: Baseline to 12 mos ]
    Quality of life will be assessed at baseline, 6, and 12 mos. 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.
  • Brain volume [ Time Frame: Baseline to 12 mos. ]
    Brain volume will be measured using structural MRI at baseline, 6, and 12 mos
  • Functional connectivity [ Time Frame: Baseline to 12 mos. ]
    Functional connectivity will be measured using resting state MRI (rsMRI) at baseline, 6, and 12 mos.
  • Cerebral blood flow [ Time Frame: Baseline to 12 mos. ]
    Functional connectivity will be measured using arterial spin labeling at baseline, 6, and 12 mos
  • Retention [ Time Frame: Baseline to 12 mos. ]
    Retention will be measured by the percentage of participants who complete the 12 mo. intervention, defined as completing the 12 mo. outcome assessments.
  • Session attendance [ Time Frame: Baseline to 12 mos ]
    Session attendance for both group MVPA and education/support sessions from baseline to 12 mos. 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.
  • Use of recorded exercise sessions [ Time Frame: Baseline to 12 mos ]
    Use of recorded exercise sessions will be tracked using Dropbox which provides information on how many times each user watched a video.
  • Reported Serious adverse event [ Time Frame: Baseline to 12 mos. ]
    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.
Current Other Pre-specified Outcome Measures
 (submitted: August 7, 2019)
  • 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.
  • Height [ Time Frame: Baseline to 12 months ]
    Standing height will be measured with a portable stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK).
  • Waist Circumference [ Time Frame: Baseline to 12 months ]
    Waist circumference will be assessed using a waist tape measure.
Original Other Pre-specified Outcome Measures
 (submitted: August 5, 2019)
  • Weight [ Time Frame: Baseline to 12 mos. ]
    Weight will be measured in light clothing on a calibrated scale (Model #PS6600, Belfour, Saukville, WI) to the nearest 0.1 kg.
  • Height [ Time Frame: Baseline to 12 mos. ]
    Standing height will be measured with a portable stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK).
  • Waist Circumference [ Time Frame: Baseline to 12 mos. ]
    Waist circumference will be assessed using a waist tape measure.
 
Descriptive Information
Brief Title  ICMJE The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome
Official Title  ICMJE The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Down Syndrome
  • Alzheimer Disease
Intervention  ICMJE
  • 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.
  • 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.
  • Behavioral: Personal Coach
    Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education.
Study Arms  ICMJE
  • Remote Low
    Intervention: Behavioral: Remote Low
  • Remote High
    Intervention: Behavioral: Remote High
  • Personal Coach
    Intervention: Behavioral: Personal Coach
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 5, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2024
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lauren Ptomey, PhD 9135887983 lptomey@kumc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04048759
Other Study ID Numbers  ICMJE STUDY00143836
R01AG063909 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Lauren Ptomey, PhD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP