CompletedNCT04048759Updated Jul 23, 2024Results posted

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

An interventional study of Remote Low and Remote High in Down Syndrome and Alzheimer Disease, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 81
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Down Syndrome
Alzheimer Disease

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Keywords

Physical Activity
Exercise

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 81 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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

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.

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 81 participants (actual)

Study arms

Other
Remote Low
Behavioral: Remote Low
Other
Remote High
Behavioral: Remote High
Other
Personal Coach
Behavioral: Personal Coach

Interventions

BehavioralRemote 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.
BehavioralRemote 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.
BehavioralPersonal Coach
Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education.

What researchers measure

Primary outcomes

Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day
MVPA was assessed using an ActiGraph tri-axial accelerometer.
Time frame: Baseline to 12 months

Secondary outcomes

Cognitive Function
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.
Time frame: Baseline to 12 months
Cardiovascular Fitness
Maximal treadmill tests (modified Balke protocol) will be completed at baseline, 6, and 12 months
Time frame: Baseline to 12 months
Change in Quality of Life
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.
Time frame: Baseline to 12 months
Brain Volume
Brain volume will be measured using structural MRI at baseline, 6, and 12 months
Time frame: Baseline to 12 months
Functional Connectivity
Functional connectivity will be measured using resting state MRI (rsMRI) at baseline, 6, and 12 months.
Time frame: Baseline to 12 months
Cerebral Blood Flow
Functional connectivity will be measured using arterial spin labeling at baseline, 6, and 12 months
Time frame: Baseline to 12 months
Retention
Retention will be measured by the percentage of participants who complete the 12 month intervention, defined as completing the 12 month outcome assessments.
Time frame: Baseline to 12 months
Session Attendance
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.
Time frame: Baseline to 12 months
Use of Recorded Exercise Sessions
Use of recorded exercise sessions will be tracked using Dropbox which provides information on how many times each user watched a video.
Time frame: Baseline to 12 months
Reported Serious Adverse Event
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.
Time frame: Baseline to 12 months

Other outcomes

Weight
Weight will be measured in light clothing on a calibrated scale (Model #PS6600, Belfour, Saukville, WI) to the nearest 0.1 kg.
Time frame: Baseline to 12 months
Height
Standing height will be measured with a portable stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK).
Time frame: Baseline to 12 months
Waist Circumference
Waist circumference will be assessed using a waist tape measure.
Time frame: Baseline to 12 months
Energy Expenditure of Exercise Sessions
The energy expenditure of sessions will be collected by a portable metabolic system at random timepoints across the 12 month study.
Time frame: Baseline to 12 months
Functional Lower Extremity Strength
Functional lower extremity strength will be assessed using the Five Times Sit to Stand
Time frame: Baseline to 12 months
Functional Mobility
Functional mobility will be assessed using the Timed Up and Go.
Time frame: Baseline to 12 months
Upper Body Strength
Upper body strength will be assessed using hand grip dynamometer
Time frame: Baseline to 12 months
Activities of Daily Living
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.
Time frame: Baseline to 12 months
Caregiver Burden
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.
Time frame: Baseline to 12 months
Caregiver Stress
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.
Time frame: Baseline to 12 months
Caregiver Quality of Life
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.
Time frame: Baseline to 12 months

Results

Posted Jul 23, 2024

Participant flow

Participant flow — Overall Study
Milestone	Remote High	Remote Low	Personal Coach
Started	34	32	15
6 month assessment	34	32	15
12 month assessment	34	32	15
Completed	34	32	15
Not completed	0	0	0

Outcome measures

PrimaryMinutes of Moderate to Vigorous Physical Activity (MVPA) Per Day

MVPA was assessed using an ActiGraph tri-axial accelerometer.

Time frame:: Baseline to 12 months
Reported as:: Mean · min of MVPA/day

Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day
min of MVPA/day	Remote High	Remote Low	Personal Coach
Absolute MVPA at Baseline	13.8 ± 13.9	17.9 ± 29.6	15.6 ± 15.8
Absolute MVPA at 3 months	21.8 ± 19.3	13.8 ± 12.6	19.9 ± 18.3
Absolute MVPA at 6 months	26.1 ± 24.4	15.9 ± 15.7	20.0 ± 18.6
Absolute MVPA at 9 months	23.9 ± 21.4	19.5 ± 24.9	17.9 ± 17.0
Absolute MVPA at 12 months	24.4 ± 23.5	14.7 ± 16.7	17.0 ± 13.9

SecondaryCognitive Function

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.

Time frame:: Baseline to 12 months