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

• ClinicalTrials.gov Identifier: NCT04048759
• Recruitment Status: Active, not recruiting
• First Posted: August 7, 2019
• Last Update Posted: December 1, 2022
• Sponsor: University of Kansas Medical Center
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): University of Kansas Medical Center

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.
4. 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.
5. Functional lower extremity strength [ Time Frame: Baseline to 12 months ]
   Functional lower extremity strength will be assessed using the Five Times Sit to Stand
6. Functional mobility [ Time Frame: Baseline to 12 months ]
   Functional mobility will be assessed using the Timed Up and Go.
7. Upper body strength [ Time Frame: Baseline to 12 months ]
   Upper body strength will be assessed using hand grip dynamometer
8. 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.
9. 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.
10. 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.
11. 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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

University of Kansas Medical Center

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Lauren Ptomey, PhD; University of Kansas Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum In: Contemp Clin Trials Commun. 2020 Dec 10;20:100690.

• 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
• 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

Keywords provided by University of Kansas Medical Center:

Physical Activity; Exercise

Additional relevant MeSH terms:

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