The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04048759 |
Recruitment Status :
Active, not recruiting
First Posted : August 7, 2019
Last Update Posted : December 1, 2022
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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 |
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 |
Actual Study Start Date : | January 21, 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. |
- 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.
- Energy Expenditure of Exercise Sessions [ Time Frame: Baseline to 12 months ]The energy expenditure of sessions will be collected by a portable metabolic system at random timepoints across the 12 month study.
- Functional lower extremity strength [ Time Frame: Baseline to 12 months ]Functional lower extremity strength will be assessed using the Five Times Sit to Stand
- Functional mobility [ Time Frame: Baseline to 12 months ]Functional mobility will be assessed using the Timed Up and Go.
- Upper body strength [ Time Frame: Baseline to 12 months ]Upper body strength will be assessed using hand grip dynamometer
- Activities of daily living [ Time Frame: Baseline to 12 months ]Activities of daily living will be assessed using the Waisman Activities of Daily Living scale. This scale contains 17 questions, each item is rated as 0="does not do", 1="does with help", or 2="does independently / on own. A higher score indicates greater independence.
- Caregiver burden [ Time Frame: Baseline to 12 months ]Caregiver burden will be assess using The Modified Caregiver Strain Index. The tool has 13 questions that measure strain related to care provision. Scoring is 2 points for each 'yes', 1 point for each 'sometimes', and 0 for each 'no' response. Scoring ranges from 26 to 0; a higher score indicates a higher level of caregiver strain.
- Caregiver stress [ Time Frame: Baseline to 12 months ]Caregiver stress will be assessed by the Caregiver Self-Assessment Questionnaire. This questionnaire is 18 questions, 16 with yes or no responses, and 2 ranking questions. Typically a higher score indicates a higher level of caregiver stress.
- Caregiver quality of life [ Time Frame: Baseline to 12 months ]Caregiver quality of life will be assessed by the Adult Carer Quality of Life Questionnaire. The Adult Carer Quality of Life Questionnaire is a 40-item instrument that measures the overall quality of life for adult carers. Scores on the have a possible range of 0 to 120 with higher scores indicating greater quality of life.

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

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
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 |
Principal Investigator: | Lauren Ptomey, PhD | University of Kansas Medical Center |
Responsible Party: | University of Kansas Medical Center |
ClinicalTrials.gov Identifier: | NCT04048759 |
Other Study ID Numbers: |
STUDY00143836 R01AG063909 ( U.S. NIH Grant/Contract ) |
First Posted: | August 7, 2019 Key Record Dates |
Last Update Posted: | December 1, 2022 |
Last Verified: | November 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Physical Activity Exercise |
Alzheimer Disease Down Syndrome 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 |