Clinical trial NCT04048759: The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome
Official title: The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Alzheimer Disease
Keywords: Physical Activity
Exercise
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-08-07
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Cognitive Function
timeFrame: Baseline to 12 months
measure: Cardiovascular Fitness
timeFrame: Baseline to 12 months
measure: Change in Quality of Life
timeFrame: Baseline to 12 months
measure: Brain Volume
timeFrame: Baseline to 12 months
measure: Functional Connectivity
timeFrame: Baseline to 12 months
measure: Cerebral Blood Flow
timeFrame: Baseline to 12 months
measure: Retention
timeFrame: Baseline to 12 months
measure: Session Attendance
timeFrame: Baseline to 12 months
measure: Use of Recorded Exercise Sessions
timeFrame: Baseline to 12 months
measure: Reported Serious Adverse Event
timeFrame: Baseline to 12 months
Other outcomes:
measure: Weight
timeFrame: Baseline to 12 months
measure: Height
timeFrame: Baseline to 12 months
measure: Waist Circumference
timeFrame: Baseline to 12 months
measure: Energy Expenditure of Exercise Sessions
timeFrame: Baseline to 12 months
measure: Functional Lower Extremity Strength
timeFrame: Baseline to 12 months
measure: Functional Mobility
timeFrame: Baseline to 12 months
measure: Upper Body Strength
timeFrame: Baseline to 12 months
measure: Activities of Daily Living
timeFrame: Baseline to 12 months
measure: Caregiver Burden
timeFrame: Baseline to 12 months
measure: Caregiver Stress
timeFrame: Baseline to 12 months
measure: Caregiver Quality of Life
timeFrame: Baseline to 12 months
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Lauren Ptomey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.