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
|Condition or disease||Intervention/treatment||Phase|
|Down Syndrome Alzheimer Disease||Behavioral: Remote Low Behavioral: Remote High Behavioral: Personal Coach||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome|
|Actual Study Start Date :||January 21, 2020|
|Estimated Primary Completion Date :||January 1, 2024|
|Estimated Study Completion Date :||January 1, 2024|
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.
- 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
- 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.
- 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.
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
|Contact: Lauren Ptomey, PhDemail@example.com|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Lauren Ptomey, PhD|
|Principal Investigator:||Lauren Ptomey, PhD||University of Kansas Medical Center|