Alzheimer Disease, Down Syndrome
Conditions
Keywords
Physical Activity, Exercise
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.
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.
Sponsors
National Institute on Aging (NIA)
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Baseline to 12 months | MVPA was assessed using an ActiGraph tri-axial accelerometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of Recorded Exercise Sessions | 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 | 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. |
| Cognitive Function | 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 | Baseline to 12 months | Maximal treadmill tests (modified Balke protocol) will be completed at baseline, 6, and 12 months |
| Change in Quality of Life | 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 | Baseline to 12 months | Brain volume will be measured using structural MRI at baseline, 6, and 12 months |
| Functional Connectivity | Baseline to 12 months | Functional connectivity will be measured using resting state MRI (rsMRI) at baseline, 6, and 12 months. |
| Cerebral Blood Flow | Baseline to 12 months | Functional connectivity will be measured using arterial spin labeling at baseline, 6, and 12 months |
| Retention | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Weight | 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 | Baseline to 12 months | Standing height will be measured with a portable stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK). |
| Waist Circumference | Baseline to 12 months | Waist circumference will be assessed using a waist tape measure. |
| Energy Expenditure of Exercise Sessions | 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 | Baseline to 12 months | Functional lower extremity strength will be assessed using the Five Times Sit to Stand |
| Functional Mobility | Baseline to 12 months | Functional mobility will be assessed using the Timed Up and Go. |
| Upper Body Strength | Baseline to 12 months | Upper body strength will be assessed using hand grip dynamometer |
| Activities of Daily Living | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Remote High 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. | 34 |
| Remote Low 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. | 32 |
| Personal Coach Personal Coach: Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education. | 15 |
| Total | 81 |
Baseline characteristics
| Characteristic | Remote High | Total | Personal Coach | Remote Low |
|---|---|---|---|---|
| Age, Continuous | 25.5 years STANDARD_DEVIATION 8.5 | 26.6 years STANDARD_DEVIATION 8.9 | 26.6 years STANDARD_DEVIATION 6.6 | 27.8 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 7 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 74 Participants | 14 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 68 Participants | 15 Participants | 21 Participants |
| Region of Enrollment United States | 34 participants | 81 participants | 15 participants | 32 participants |
| Sex: Female, Male Female | 19 Participants | 45 Participants | 7 Participants | 19 Participants |
| Sex: Female, Male Male | 15 Participants | 36 Participants | 8 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 32 | 0 / 15 |
| other Total, other adverse events | 7 / 34 | 1 / 32 | 4 / 15 |
| serious Total, serious adverse events | 2 / 34 | 3 / 32 | 1 / 15 |
Outcome results
Primary
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
Population: Only participants who had valid accelerometer wear time (8 hrs a day for at least 3 weekdays/1weekend day) are included at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remote High | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Absolute MVPA at 9 months | 23.9 min of MVPA/day | Standard Deviation 21.4 |
| Remote High | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Absolute MVPA at 6 months | 26.1 min of MVPA/day | Standard Deviation 24.4 |
| Remote High | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Absolute MVPA at Baseline | 13.8 min of MVPA/day | Standard Deviation 13.9 |
| Remote High | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Absolute MVPA at 3 months | 21.8 min of MVPA/day | Standard Deviation 19.3 |
| Remote High | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Absolute MVPA at 12 months | 24.4 min of MVPA/day | Standard Deviation 23.5 |
| Remote Low | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Absolute MVPA at 6 months | 15.9 min of MVPA/day | Standard Deviation 15.7 |
| Remote Low | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Absolute MVPA at Baseline | 17.9 min of MVPA/day | Standard Deviation 29.6 |
| Remote Low | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Absolute MVPA at 3 months | 13.8 min of MVPA/day | Standard Deviation 12.6 |
| Remote Low | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Absolute MVPA at 9 months | 19.5 min of MVPA/day | Standard Deviation 24.9 |
| Remote Low | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Absolute MVPA at 12 months | 14.7 min of MVPA/day | Standard Deviation 16.7 |
| Personal Coach | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Absolute MVPA at 12 months | 17.0 min of MVPA/day | Standard Deviation 13.9 |
| Personal Coach | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Absolute MVPA at 9 months | 17.9 min of MVPA/day | Standard Deviation 17 |
| Personal Coach | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Absolute MVPA at Baseline | 15.6 min of MVPA/day | Standard Deviation 15.8 |
| Personal Coach | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Absolute MVPA at 6 months | 20.0 min of MVPA/day | Standard Deviation 18.6 |
| Personal Coach | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | Absolute MVPA at 3 months | 19.9 min of MVPA/day | Standard Deviation 18.3 |
Secondary
Brain Volume
Brain volume will be measured using structural MRI at baseline, 6, and 12 months
Time frame: Baseline to 12 months
Secondary
Cardiovascular Fitness
Maximal treadmill tests (modified Balke protocol) will be completed at baseline, 6, and 12 months
Time frame: Baseline to 12 months
Secondary
Cerebral Blood Flow
Functional connectivity will be measured using arterial spin labeling at baseline, 6, and 12 months
Time frame: Baseline to 12 months
Secondary
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
Secondary
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
Secondary
Functional Connectivity
Functional connectivity will be measured using resting state MRI (rsMRI) at baseline, 6, and 12 months.
Time frame: Baseline to 12 months
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
Functional Lower Extremity Strength
Functional lower extremity strength will be assessed using the Five Times Sit to Stand
Time frame: Baseline to 12 months
Other Pre-specified
Functional Mobility
Functional mobility will be assessed using the Timed Up and Go.
Time frame: Baseline to 12 months
Other Pre-specified
Height
Standing height will be measured with a portable stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK).
Time frame: Baseline to 12 months
Other Pre-specified
Upper Body Strength
Upper body strength will be assessed using hand grip dynamometer
Time frame: Baseline to 12 months
Other Pre-specified
Waist Circumference
Waist circumference will be assessed using a waist tape measure.
Time frame: Baseline to 12 months
Other Pre-specified
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