Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
Phase: NA
Conditions: Down Syndrome, Physical Inactivity
Sponsor: University of Kansas Medical Center

 
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Decreasing Alzheimer’s risk through oNline Choreographed Exercise – Down Syndrome 
(DANCE-DS) Protocol 
 
PROTOCOL TITLE: 
Decreasing Alzheimer’s risk through oNline Choreographed Exercise – Down Syndrome 
(DANCE-DS) 
PRINCIPAL INVESTIGATOR: 
Lauren T. Ptomey, PhD, RD, LD 
Department of Internal Medicine 
Division of Physical Activity and Weight Management 
913-588-7983 
lptomey@kumc.edu 
 
VERSION NUMBER/DATE: 
Version 1; June 12th 2024 
 
REVISION HISTORY 
 
Revision 
# 
Version 
Date 
Summary of Changes 
Consent 
Change? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table of Contents 
1.0 
Study Summary ................................................................................................................. 3 
2.0 
Objectives ........................................................................................................................... 4 
3.0 
Background ........................................................................................................................ 4 
4.0 
Study Endpoints ................................................................................................................ 5 
5.0 
Study Intervention/Investigational Agent ....................................................................... 5 
6.0 
Procedures Involved ......................................................................................................... 6 
7.0 
Data and Specimen Banking ........................................................................................... 7 
8.0 
Sharing of Results with Subjects .................................................................................... 7 
9.0 
Study Timelines ................................................................................................................. 7 
10.0 Inclusion and Exclusion Criteria ...................................................................................... 8 
11.0 Vulnerable Populations .................................................................................................... 8 
12.0 Local Number of Subjects ................................................................................................ 8 
13.0 Recruitment Methods........................................................................................................ 8 
14.0 Withdrawal of Subjects ..................................................................................................... 9 
15.0 Risks to Subjects ............................................................................................................... 9 
16.0 Potential Benefits to Subjects ......................................................................................... 9 
17.0 Data Management and Confidentiality ........................................................................... 9 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects ............................ 10 
19.0 Provisions to Protect the Privacy Interests of Subjects ............................................. 11 
20.0 Compensation for Research-Related Injury ................................................................ 11 
21.0 Economic Burden to Subjects ....................................................................................... 11 
22.0 Consent Process ............................................................................................................. 11 
23.0 Process to Document Consent in Writing ................................................................... 12 
24.0 Setting ............................................................................................................................... 12 
25.0 Resources Available ....................................................................................................... 12 
26.0 Multi-Site Research ......................................................................................................... 13 
 
 
 

 
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1.0 
Study Summary 
 
Protocol Information  
Description  
Study Title 
Decreasing Alzheimer’s Risk through Online Choreographed 
Exercise (DANCE) – Down Syndrome 
Study Design 
Single Arm Pilot Feasibility Trial 
Primary Objective 
To assess the feasibility of a 12 week remotely delivered 
group dance intervention.   
Secondary 
Objective(s) 
1. To assess changes in aerobic fitness and cognitive 
function in response to a 12 week remotely delivered 
group dance intervention.   
2. To assess the intensity and total energy expenditure of 
remotely delivered group dance sessions 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Adults with Down syndrome (n=20) will participate in a 12 
week, remotely delivered choreographed exercise 
intervention. Classes will take place 2 times per week and 
be 35 minutes in length. 
IND/IDE #  
NA 
Study Population 
Adults (age 18-64) with Down syndrome 
Sample Size 
20 
Study Duration for 
individual 
participants 
12 Weeks 
Study Specific 
Abbreviations/ 
Definitions  
AD, Alzheimer’s Disease; DS, Down syndrome; ID, 
intellectual disability; MVPA, moderate-to-vigorous physical 
activity 
 
 

 
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2.0 
Objectives 
2.1 Adults with Down syndrome (n=20) will participate in a 12 week, remotely 
delivered choreographed exercise intervention. Classes will take place 2 
times per week and be 35 minutes in length. Prior to the start of the 
intervention (baseline) and at the conclusion of the intervention (week 12), 
aerobic fitness (6-minute walk test), cognitive function (modified cued 
recall), and physical activity enjoyment will be assessed. Attendance, 
retention, and adverse events will be collected on an ongoing basis 
throughout the intervention. The purpose of this pilot project is to assess 
the usability, feasibility, and preliminary effectiveness of a remotely 
delivered choreographed exercise intervention for the prevention of 
Alzheimer’s disease in adults with Down syndrome. This project will 
address the following aims:  
• Aim 1: Assess the feasibility of a 12 week. remotely delivered 
group dance intervention 
• Aim 2: Assess changes in aerobic fitness and cognitive function in 
response to a 12 week remotely delivered group dance 
intervention 
• Aim 3: Assess the intensity and total energy expenditure of 
remotely delivered group dance sessions 
2.2 We hypothesize the following: 
• Aim 1: Session attendance and participant retention will be ≥ 80%, 
and physical activity enjoyment (measured using the Physical 
Activity Enjoyment Disabilities Scale) will increase from baseline 
to week 12 
• Aim 2: We expected significant improvements in aerobic fitness 
and cognitive function across the 12 week intervention 
• Aim 3: Energy expenditure will exceed ≥3.0 METs during the 
exercise sessions and average heart rate will reach 65 % of age-
estimated maximal heart rate  
3.0 
Background 
 
Down syndrome (DS) or trisomy 21 is the most common chromosomal 
abnormality associated with an intellectual disability (ID) [1]. The current incidence of DS 
is 1 in every 650 live births [2, 3] which is ~30% higher than in 1979, largely due to 
women conceiving after age 35 [4]. Consequently, the prevalence of DS in the U.S. 
increased from an estimated 49,923 in 1950 to ~250,700 individuals in 2017 [3, 5]. 
The life expectancy for individuals with DS has increased dramatically in recent decades 
from 4 yrs. in the 1970’s due to high rates of congenital heart defects, to 60 yrs. 
currently[6]. Alzheimer's disease (AD) is currently the leading cause of death in 
individuals with DS. All adults with DS will develop pathology related with Alzheimer's 
disease (AD)[4, 7, 8]. The median age of dementia onset is 53.8 years[9], and the 
lifetime incidence is 90% [8, 10].  
For adults without DS, increased moderate-to-vigorous physical activity (MVPA) 
during mid-life [11-14] and older adulthood [15-17] may be effective in maintaining or 
improving components of cognition, including attention, memory, and executive function. 

 
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MVPA obtained through structured exercise appears to have the greatest benefit on 
cognition [18-20]. The limited research in adults with DS suggests that MVPA is closely 
associated with cognition[21, 22]. For example, Fleming et al. [21] reported that percent 
of time spent in MVPA was significantly correlated with 8/9 cognitive outcomes used the 
ABC-DS cognitive battery [23]. Similarly, a study by Pape et al. [22] which followed 214 
participants across 12 months, observed that higher MVPA at baseline was associated 
with a 62% reduced risk of decline in memory and orientation at 12 months. Additionally, 
previous intervention studies in adults with DS have demonstrated the potential for acute 
or short-term (≤ 12 wks.) exercise to improve cognitive outcomes [24-28]. For example, 
Chen et al [29] compared the response of 3 components of executive function (choice-
response time, attention shifting and inhibition) to an acute bout of moderate intensity 
exercise (20 min treadmill walk, n=10) with an attentional control (20 min video, n=10) in 
adults with DS. Compared to the control group, participants in the exercise group had 
non-significant improvements in choice-response time (p = 0.32) and attention shifting (p 
= 0.13). Participants in the exercise group had statistically significant improvement in 
inhibition compared with control (p = 0.03).   
While MVPA might serve to benefit those with DS, it is estimated that only 9% of 
adults with ID, including those with DS, [30] achieve 150 minutes per week of MVPA as 
recommend by the Physical Activity Guidelines for Americans [31] compared with ~52% 
of typically developed adults [32]. Adults with DS face unique barriers to participation in 
MVPA including disinterest or inability to participate in typical exercise modes, e.g., 
walking, jogging etc., challenges with gait and/or coordination, lack of access to adapted 
options for MVPA, and lack of social support and low self-efficacy for exercise [33, 34]. 
Previous research[35]/observations by our group and others suggests that dance 
activities are a preferred form of exercise for adults with DS.  Dance, which is 
characterized by rhythmic physical movements offers the potential for social 
engagement, and stimulation of brain functions including attention, memory, executive 
function, and visuospatial processing that are commonly affected by aging and cognitive 
decline [36, 37], particularly in individuals with DS.  However, empirical evidence to 
support the feasibility of a remotely delivered group dance intervention and evaluation of 
the intensity and energy expenditure achieved by a dance intervention for adults with DS 
are currently unavailable and will be the focus of the proposed pilot trial. 
 
4.0 
Study Endpoints 
4.1 The primary study endpoint is at the conclusion of the 12 week intervention. 
A secondary endpoint is upon participant withdrawal.  
4.2 Participants will be removed from the study due to safety concerns if any 
arise.  
5.0 
Study Intervention/Investigational Agent 
Adults with DS (n=20, age = 18 to 64 yrs.) will be asked to attend 35 min. remotely 
delivered (Zoom®) group dance sessions twice weekly across 12 weeks. All sessions will 
be directed by an instructor experienced in leading 35 min, group remote exercise 
sessions for individuals with intellectual disability as part of the ongoing exercise 
program for individuals with intellectual disability offered by the Division for Physical 
Activity and Weight Management. Classes will include a 5-minute warm up, 25 minutes 
of exercise designed to target moderate intensity activity, and a 5 minute cool down. 
During the 25 minutes of exercise, approximately 15 minutes of this section will be used 
to complete “floor progressions”. In a traditional dance class, “floor progressions” are 

 
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used to practice fundamental dance skills while traveling across the floor, such as 
marching across the floor to the beat of the music, side shuffle across the floor, or step-
kicks across the floor. Participants will be asked to do this style of movement in place or 
within a radius where they can move safely in their homes and stay within range of the 
video camera so that exercise instructors can ensure participant safety. The final 10 
minutes of the 25-minute exercise block will be used to teach dance moves as a part of 
a choreographed exercise routine which will be learned over the course of 12 weeks. 
Participants will start this section by practicing parts of the dance learned in a previous 
session or by learning new sections of the dance. Types of moves used in this dance 
routine will be similar to those used in the “floor progression” segment, including 
marching to the beat for an 8-count of music, stepping and clapping for an 8-count of 
music, swaying arms while stepping side to side for an 8-count. The choreographed 
dance will be designed by an individual experienced with teaching dance to adults with 
intellectual disabilities to ensure it is level appropriate. Each week, participants will learn 
1-2 new dance moves as a part of the choreographed dance and practice these moves 
with the music assigned to the dance with the instructor as a part of class. 
 
6.0 
Procedures Involved 
6.1 This is a 12-week pilot intervention for 20 adults with Down syndrome. The 
intervention will include a 2x weekly choreographed exercise intervention 
led by staff trained to deliver exercise interventions in this population. The 
structure of the class will be similar to that used in the ongoing remote 
exercise program for individuals with intellectual disability offered by the 
Division for Physical Activity and Weight Management, but substituting 
choreographed exercise (dance) movements to replace the aerobic 
component of this program. Participants will be asked to attend 2x weekly 
group classes remotely using Zoom® video conferencing (San Jose, CA). 
All outcomes will be assessed by research assistants at baseline and week 
12, with the exception of the energy expenditure assessment and weekly 
class attendance. Outcome assessments will take place at the University of 
Kansas Medical Center, in Kansas City, KS. Intervention classes will take 
place in participant homes, using self-provided devices.  
6.2 All assessments will be completed by appropriately trained staff with 
experience conducting assessments in adults with Down syndrome.   
6.3 Anthropometrics. Research staff will measure weight, height, waist 
circumference, and hip circumference. Weight will be measured on a 
calibrated scale to the nearest 0.1 kg. Standing height will be measured 
with a stadiometer. BMI will be calculated as weight (kg)/height (m2). Waist 
and hip circumference will be assessed using standard procedures such as 
those described by Lohman et al. [38].  Two measurements will be obtained 
with the outcome recorded as the average of the closest 2 measures.  
Blood Pressure and Heart Rate will also be collected following a period of 
seated rest (≥5 minutes).  
6.4 Demographics. Basic demographic information including age, date of birth, 
race, ethnicity, sex, gender identity, and a brief health history will be 
collected at the baseline assessment.  
6.5 Aerobic fitness. Aerobic fitness will be assessed using the 6-minute walk 
test [39-41] at baseline and week 12. Participants will be asked to 

 
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continuously walk along a pre-measured walking course for a total of six 
minutes. Participants are free to self-select pace of this walk and take 
breaks as needed. The total distance covered in the allotted time will be 
recorded.  
6.6 Cognitive function. The Modified Cued Recall Test (mCRT)[42] will be used 
to assess cognitive function. The mCRT is used to assess episodic 
memory, and is a version specifically modified for individuals with DS. 
During this assessment, participants are asked to recall 12 objects 
previously shown to them using a set of cards following a learning phase. 
Participants are given one minute to freely recall these items before 
receiving category-based cues to retrieve remaining items. Participants are 
asked to complete this for a total of three trials and the total number of 
items across all three trials is summed. 
6.7 Energy Expenditure of Remote Exercise Sessions. Energy expenditure of 
the remote sessions will be assessed using a previously validated portable, 
open-circuit indirect calorimeter (Cosmed, Italy) which measures breath-by-
breath ventilation, expired oxygen, and carbon dioxide. The flow turbine will 
be calibrated using a 3.0-L syringe. The lightweight (~1.5 kg) portable 
system will be attached by a harness around the waist and shoulders of the 
participant before each assessment.  During exercise sessions, participants 
will breathe into a facemask that directs air into the unit housing the O2 and 
CO2 analyzers. Data will be retrieved for analysis via a serial port interface 
and software provided with the calorimeter and aggregated over 20-second 
epochs for the calculation of 1-min averages. MET levels will be age 
corrected using the Schofield equation as recommended by McMurray et 
al.[43]. Participants will also be provided with a FitBit device to measure 
heart rate achieved during the exercise sessions. Exercise instructors will 
remind participants to start and stop devices at the beginning and end of 
each exercise session. Device data will be shared with research staff.  
6.8 Attendance at remote exercise sessions. After each session, the 
interventionist will record attendance. Overall attendance will be expressed 
as the percentage of possible sessions attended.  
6.9 Physical Activity Enjoyment. Physical activity enjoyment will be assessed at 
baseline and week 12 of the intervention using the Physical Activity 
Enjoyment Scale [44]. Exercise self-efficacy will also be assessed at 
baseline and week 12.  Self-efficacy will be assessed using the Self-
Efficacy for Activity for Persons with Intellectual Disabilities Scale [45].  
Finally, participants will complete a survey of intervention implementation 
success (acceptability, appropriateness, feasibility) assessed using 
validated 5-point Likert scales [46] at week 12 of the intervention. 
Participants will complete these surveys via REDCap. 
 
7.0 
Data and Specimen Banking NA 
8.0 
Sharing of Results with Subjects 
8.1 Study results will not be shared with participants. 
9.0 
Study Timelines 

 
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9.1 The intervention will last for 12 weeks. Baseline testing visits will occur 
within two weeks of the start of the intervention and week 12 visits will 
occur within 2 weeks of the program ending. Based on these parameters, 
study enrollment will last up to 16 weeks including pre, and post 
intervention testing.  
9.2 Participants will be recruited in two cohorts of 10 participants each. It is 
projected for the first cohort to begin in the Fall of 2024, with recruitment 
taking place in summer and early fall. The second cohort will begin in early 
2025, with ongoing recruitment efforts starting during the delivery of the 
intervention to the first cohort.  
9.3 Primary analyses will be completed in Summer 2025, following the 
conclusion of the second cohort. This will allow ample time for data 
collection and processing from both cohorts.  
10.0 Inclusion and Exclusion Criteria 
10.1 First, interested participants will complete a web-based initial eligibility 
questionnaire using REDCap, where they will provide the age, sex, race, 
and answer questions related to inclusion/exclusion. Those deemed 
potentially eligible will be contacted for a phone screen to determine final 
eligibility and discuss informed consent. 
10.2 Remote video chat sessions (Zoom) or a phone call will be scheduled with 
participants and their legal guardian (if applicable) deemed to be initially 
eligible. During this call, the research study will be explained to participants 
and their legal guardian (if applicable) and eligibility criteria will be 
assessed.  
10.3 Inclusion criteria: 1) Age 18-64 yrs. with a diagnosis of Down syndrome. 2) 
Sufficient functional ability to communicate through spoken language.3) No 
plans to relocate outside the study area over the next 12 weeks 4) 
Possession of a personal device that allows for connectivity to the internet 
and participate in 2x weekly group video calls. 5) Ability to participate in 
moderate intensity physical activity 
10.4 Exclusion criteria: 1) Serious medical risk (e.g., cancer, recent heart attack, 
stroke, pregnancy, angioplasty as determined by the research staff. 2) 
unwilling to participate in outcomes assessments 3) uninterested  
11.0 Vulnerable Populations 
11.1 Study procedures will be explained in an appropriate manner by Staff 
familiar in working with adults with Down syndrome. Adequate time will be 
given for questions and consideration by both the potential participant and a 
caregiver. 
12.0 Local Number of Subjects 
12.1 A total of 20 participants will be recruited to join the study, across two 
cohorts of 10 participants.  
13.0 Recruitment Methods 

 
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13.1 The recruitment plan was informed by our experience with completed 
projects where we successfully recruited adults with DS [47-49]. As in our 
previous trials, project staff will contact local community agencies serving 
adults with DS, case managers, and CDDOs by mail or email, provide 
presentations at CDDO meetings, and text for CDDO newsletters 
describing the project. Interested adults with DS or their parent/caregiver 
will be asked to contact the study coordinator via email or a dedicated toll-
free study phone number that will be included in all recruitment materials. 
Participants will complete a basic eligibility survey using REDCap. The 
study coordinator will then contact those deemed eligible by phone to 
answer questions and conduct and ensure eligibility. Zoom® meetings will 
be scheduled with those remaining interested and potentially eligible to 
complete eligibility screening and to obtain informed consent or 
parent/guardian consent and participant assent in cases where the 
participant has a surrogate decision maker.  
13.2 A flyer will be sent to all parties listed above and used for recruitment 
purposes. This flyer will include basic study information and contact 
information for research staff. A copy of the flyer us attached.    
14.0 Withdrawal of Subjects 
14.1 Participants will be withdrawn from the research without their consent if an 
SAE occurs which is deemed by the study team and PI and unsafe for 
continued participation.  
14.2 Upon withdrawal from the study, all research activities will cease, and no 
additional data will be collected. Participants will no longer be able to attend 
the weekly exercise classes.  
15.0 Risks to Subjects 
15.1 Injury during physical activity. There is a chance for physical injury during 
physical activity such as muscle and joint sprains or strains, muscle 
cramps, and inflammation. These risks will be monitored and minimized by 
conducting a warmup as a part of each exercise class.  
16.0 Potential Benefits to Subjects 
16.1 Individual subject. Benefits to individual participants include the well-
established benefits of physical activity engagement, including increased 
fitness and functional capacity, cognitive improvements, and mood 
improvements. Participants may also benefit from engaging in a group 
setting during the classes.  
16.2 Population. The information from this study will aid in the understanding of 
the role of choreographed exercise in physical activity enjoyment and 
fitness and cognitive improvements for this population. This study may 
provide guidance for future interventions designed to increase physical 
activity for this population, with the goal of increasing cardiovascular fitness 
and reducing risk of Alzheimer’s disease.  
17.0 Data Management and Confidentiality 

 
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17.1 The primary aim of this study is to determine the preliminary feasibility and 
effectiveness of a 12 week remote intervention. As this is a pilot study, the 
sample size is not sufficient to determine true intervention effectiveness, 
however it will provide sufficient data to guide future studies. Other studies 
with similar design included between 12 and 30 participants [27, 50, 51], 
which is how the sample size for this pilot project was derived. 
• Pre and post scores for the Physical Activity Enjoyment Scale, 6 
minute walk, and cognitive assessments will be compared using 
paired sample t tests. Effect sizes (Cohen’s d) will also be 
calculated.  
17.2 This study will use a REDCap database for data management. Paper 
copies from the energy expenditure assessments will be stored in a locked 
file cabinet inside a locked office that is only accessible by authorized study 
personnel. 
Data access: Only the study team at The University of Kansas Medical 
Center (i.e., principal investigator, co-investigators, study coordinator, and 
research assistant) will have access to the study folder and REDCap 
database. 
17.3 To assure data collected are accurate and consistent, the same research 
assistants will complete data collection for all participants. Data entered into 
REDCap by the research staff will undergo data validation checks by 
another member of research staff not involved in data entry.  
18.0 Provisions to Monitor the Data to Ensure the Safety of 
Subjects 
18.1 An adverse event (AE) is any unfavorable medical occurrence in a human 
subject participant including any abnormal sign, symptom, or disease that is 
temporally associated with the participants’ involvement in the research 
even if it is not considered related to the participation in the study. Signs 
and symptoms that are consistent with normal exercise including work-
related dyspnea, fatigue, sweating, or light soreness of muscles will not be 
considered AEs. A serious adverse event (SAE) is defined as any adverse 
event that results in death, a life-threatening event, inpatient hospitalization, 
or a permanent disability.   
AEs and SAEs will be tracked by the research assistant, study coordinator, 
or principal investigator for each exercise session. These events will be 
tracked on an adverse event form in REDCap and will include any events 
that occurred during or after the exercise sessions. Each reported event will 
be documented if it meets the criteria for an AE or SAE. Documentation will 
include a description of the event, when and how it happened, and any 
documentation to determine event severity and relatedness to the research 
study. Follow-up for each occurrence will be initiated by the study team and 
continued until the event is resolved. The principal investigator for the study 
will review and evaluate adverse events within 72 hours and a summary of 
these events can be provided to the IRB on an annual basis. Deaths will be 
reported within 24 hours and unanticipated SAEs will be reported within 48 
hours to the IRB. All other SAEs will be reported semi-annually.  

 
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Muscular or joint-related injuries and cardiovascular events due to vigorous 
physical activity are the primary risks for this study, but this risk is 
attenuated with the warm up built into the program of each class. This risk 
is also minimized by the rest periods, if needed. The data safety monitoring 
plan will include close monitoring of each participant during the exercise 
testing at baseline and week 12 by the research assistants who have 
exercise testing experience in special populations, including those with 
Down syndrome. The principal investigator will be responsible for the 
immediate reporting of excessive or serious events to the IRB at The 
University of Kansas Medical Center. Safety reports will be compiled by the 
principal investigator throughout the study and the frequency of data review 
will differ based on the type and availability of the data collected and the 
perceived risk level. Data review will also include quarterly review of subject 
accrual (e.g., demographics, inclusion/exclusion) and compliance to the 
protocol; monthly review of adverse event rates; and semi-annual review of 
the stopping rules.  
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 Any data, forms, reports, video recordings, and other records that leave the 
site will be identified only by a participant identification number (Participant 
ID, PID) to maintain confidentiality. All records will be kept in a locked file 
cabinet. All computer entry and networking programs will be done using 
PIDs only. Information will not be released without written permission of the 
participant, except as necessary for monitoring by IRB, the FDA, the NIA, 
and the OHRP. 
19.2 All research staff have training to work with adults with DS. This training 
includes describing research to participants, ensuring participant safety, 
and ensuring participant comfort. Participants and caregivers are 
continually reminded that their participation in any study procedure is 
voluntary. 
20.0 Compensation for Research-Related Injury NA 
21.0 Economic Burden to Subjects 
21.1 Participants are responsible for providing their own transportation to and 
from the research center for testing visits.  
22.0 Consent Process 
22.1 
Consenting Procedure Remote video chat sessions (Zoom) or in person consent 
meetings depending on participant preference, will be scheduled with participants, 
caregivers, and their legal guardian (if applicable) deemed to be initially eligible to 
describe the project in detail, answer questions, verify eligibility, and to obtain participant 
consent or, if the participant is not their own legal guardian, guardian consent and 
participant assent. Medical consent from the participant’s physician will also be obtained 
prior to enrollment in the study. The physician will receive a description of the study, and 
a request for medical clearance to participate in the physical activity. 
22.2 
For remote video chat sessions (Zoom): Prior to the consenting session, the 
participant will be sent the consent form and cover letter through Kansas University 
Medical Center’s (KUMC) secure email system. Study staff will set up a virtual Zoom 
meeting that allows for remote video chat. Study staff will “share screen” the consent 
document and walk through each section, noting questions that arise, and answer these 

 
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questions fully. The signed and dated consent form will be submitted online through 
REDCap.  
22.3 
For in person consent meetings: study staff will meet at a mutually chosen 
location to meet with the potential participant, study partner, and legal guardian (if 
applicable). They will review the study with them, read the informed consent to them, 
and answer any questions. The participant will be allowed to keep the consent form and 
read over on their own and join at a later time. We will collect informed consent from 
participants, or if a participant is not their own legal guardian, we will collect participant 
assent and legal guardian/surrogate decision maker consent. We will obtain assent 
away from family members to make sure participants don't feel like they have to be in 
the study.  
Cognitively Impaired Adults 
The consent process for participants with known or suspected cognitive 
impairment includes an assessment of the capacity to provide consent for 
oneself. If the participant does not demonstrate capacity to consent, written 
consent will be obtained from the proper surrogate decision-maker, 
following Kansas law for DPOA and next-of-kin.  In these instances, the 
participant’s assent will be obtained and documented as well. Each team 
member qualified to consent has training on the ADRC SOP regarding 
consenting participants with impaired decision making and will follow the 
guidelines in the ADRC SOP Consenting Cognitively Impaired Participants 
to determine if subject is capable of consenting. In addition, all team 
members have experience consenting individuals with either DS or 
dementia or AD previously.  
Adults Unable to Consent NA 
23.0 Process to Document Consent in Writing NA 
24.0 Setting 
24.1 Potential research participants will be identified and recruited through 
contact with local community agencies serving adults with DS, case 
managers, and CDDOs by mail or email, provide presentations at CDDO 
meetings, and text for CDDO newsletters describing the project. 
24.2 All research activities will be performed at the Division of Physical Activity 
and Weight Management or Kirmayer Fitness Center on campus of KUMC, 
with the exception of the energy expenditure assessment. Since classes 
are held remotely, research staff will travel to participant homes or 
wherever they engage with these classes to perform this assessment.  
25.0 Resources Available 
25.1 The Division of Physical Activity and Weight management currently 
maintains a listserve of over 230 contacts in the community that serve 
adults with Down syndrome. The division has been able to successfully 
recruit cohorts of 20 participants at a time for a previous Down syndrome 
physical activity study within a 1-year time frame. 
25.2 KUMC Clinical Weight Management (Kirmayer Building) is a 5,000 ft2 
facility, that originally served as a Sports Medicine Clinic and has been 
occupied by The Division of Physical Activity and Weight Management 

 
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since the spring of 2012. This facility includes the following:  an 800 ft2 
waiting room, 4 staff offices, an office suite for project coordinators, 4 exam 
rooms ( ~ 120 ft2), a conference room, and an exercise room for conducting 
supervised aerobic or resistance exercise with adjacent handicap 
accessible locker rooms for both men and women, and extensive audio and 
video entertainment packages to facilitate participant compliance.  
25.3 All assessments will be completed by appropriately trained staff. Baseline 
and 12-week outcomes will be assessed at our facilities at KUMC. Staff will 
receive refresher training and complete reliability assessments for all 
physical measures 2-3 times/yr. All dance exercise sessions will be video 
recorded and 20% will be reviewed by study staff. The content delivered 
during each session will be compared with a checklist of scheduled content. 
Interventionists presenting < 80% of the scheduled content for any session 
will receive additional training and will be dismissed if the problem recurs. 
26.0 Multi-Site Research NA 
 

 
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References   
 
1. 
World Health Organization, Definition: intellectual disability. Retrieved from World 
Health Organization. Regional Office for Europe website: http://www. euro. who. 
int/en/what-we-do/health-topics/noncommunicable-diseases/mental-
health/news/news/2010/15/childrens-right-to-family-life/definitionintellectual-
disability, 2014. 
2. 
Wu, J. and J.K. Morris, The population prevalence of Down’s syndrome in 
England and Wales in 2011. European Journal of Human Genetics, 2013. 21(9): 
p. 1016. 
3. 
De Graaf, G., F. Buckley, and B.G. Skotko, Estimation of the number of people 
with Down syndrome in the United States. Genetics in Medicine, 2017. 19(4): p. 
439. 
4. 
Zigman, W.B., Atypical aging in Down syndrome. Developmental disabilities 
research reviews, 2013. 18(1): p. 51-67. 
5. 
Presson, A.P., et al., Current estimate of Down Syndrome population prevalence 
in the United States. J Pediatr, 2013. 163(4): p. 1163-8. 
6. 
Englund, A., et al., Changes in mortality and causes of death in the Swedish 
Down syndrome population. American Journal of Medical Genetics Part A, 2013. 
161(4): p. 642-649. 
7. 
Hartley, D., et al., Down syndrome and Alzheimer's disease: Common pathways, 
common goals. Alzheimer's & Dementia, 2015. 11(6): p. 700-709. 
8. 
Fortea, J., et al., Clinical and biomarker changes of Alzheimer's disease in adults 
with Down syndrome: a cross-sectional study. The Lancet, 2020. 395(10242): p. 
1988-1997. 
9. 
Iulita, M.F., et al., Association of Alzheimer disease with life expectancy in people 
with Down syndrome. JAMA network open, 2022. 5(5): p. e2212910-e2212910. 
10. 
McCarron, M., P. McCallion, E. Reilly, and N. Mulryan, A prospective 14‐year 
longitudinal follow‐up of dementia in persons with D own syndrome. Journal of 
Intellectual Disability Research, 2014. 58(1): p. 61-70. 
11. 
Zotcheva, E., et al., Midlife physical activity, psychological distress, and dementia 
risk: the HUNT study. Journal of Alzheimer's Disease, 2018. 66(2): p. 825-833. 
12. 
Hörder, H., et al., Midlife cardiovascular fitness and dementia: a 44-year 
longitudinal population study in women. Neurology, 2018. 90(15): p. e1298-
e1305. 
13. 
Andel, R., et al., Physical exercise at midlife and risk of dementia three decades 
later: a population-based study of Swedish twins. J Gerontol A Biol Sci Med Sci, 
2008. 63(1): p. 62-6. 
14. 
Erickson, K.I., et al., Physical Activity, Cognition, and Brain Outcomes: A Review 
of the 2018 Physical Activity Guidelines. Med Sci Sports Exerc, 2019. 51(6): p. 
1242-1251. 
15. 
Lautenschlager, N.T., et al., Effect of physical activity on cognitive function in 
older adults at risk for Alzheimer disease: a randomized trial. Jama, 2008. 
300(9): p. 1027-1037. 

 
Page 15 of 17 
Template Revision Date: December 1, 2023 
 
16. 
Bherer, L., K.I. Erickson, and T. Liu-Ambrose, A review of the effects of physical 
activity and exercise on cognitive and brain functions in older adults. Journal of 
aging research, 2013. 2013. 
17. 
Smith, P.J., et al., Aerobic exercise and neurocognitive performance: a meta-
analytic review of randomized controlled trials. Psychosomatic medicine, 2010. 
72(3): p. 239-252. 
18. 
Northey, J.M., et al., Exercise interventions for cognitive function in adults older 
than 50: a systematic review with meta-analysis. British journal of sports 
medicine, 2018. 52(3): p. 154-160. 
19. 
Ludyga, S., et al., Systematic review and meta-analysis investigating moderators 
of long-term effects of exercise on cognition in healthy individuals. Nature human 
behaviour, 2020. 4(6): p. 603-612. 
20. 
Northey, J.M., et al., Exercise interventions for cognitive function in adults older 
than 50: a systematic review with meta-analysis. Br J Sports Med, 2018. 52(3): p. 
154-160. 
21. 
Fleming, V., et al., Physical activity and cognitive and imaging biomarkers of 
Alzheimer's disease in Down syndrome. Neurobiology of aging, 2021. 107: p. 
118-127. 
22. 
Pape, S.E., et al., The association between physical activity and CAMDEX-DS 
changes prior to the onset of Alzheimer’s disease in Down Syndrome. Journal of 
Clinical Medicine, 2021. 10(9): p. 1882. 
23. 
Handen, B.L., et al., The Alzheimer's biomarker consortium‐Down Syndrome: 
rationale and methodology. Alzheimer's & Dementia: Diagnosis, Assessment & 
Disease Monitoring, 2020. 12(1): p. e12065. 
24. 
Ptomey, L.T., et al., Changes in cognitive function after a 12-week exercise 
intervention in adults with Down syndrome. Disability and Health Journal, 2018. 
11(3): p. 486-490. 
25. 
Nianogo, R.A., et al., Risk Factors Associated With Alzheimer Disease and 
Related Dementias by Sex and Race and Ethnicity in the US. JAMA Neurology, 
2022. 79(6): p. 584-591. 
26. 
Chen, C.C. and S. Ringenbach, Dose–response relationship between intensity of 
exercise and cognitive performance in individuals with Down syndrome: a 
preliminary study. Journal of Intellectual Disability Research, 2016. 60(6): p. 606-
614. 
27. 
Chen, C.C. and S. Ringenbach, The effect of acute exercise on the performance 
of verbal fluency in adolescents and young adults with Down syndrome: a pilot 
study. Journal of Intellectual Disability Research, 2019. 63(6): p. 614-623. 
28. 
Ringenbach, S.D., A.R. Albert, C.-C. Chen, and J.L. Alberts, Acute bouts of 
assisted cycling improves cognitive and upper extremity movement functions in 
adolescents with Down syndrome. Mental Retardation, 2014. 52(2): p. 124-135. 
29. 
Chen, C.C., et al., The association between a single bout of moderate physical 
activity and executive function in young adults with Down syndrome: a 
preliminary study. Journal of Intellectual Disability Research, 2014. 
30. 
Dairo, Y.M., J. Collett, H. Dawes, and G.R. Oskrochi, Physical activity levels in 
adults with intellectual disabilities: A systematic review. Preventive medicine 
reports, 2016. 4: p. 209-219. 

 
Page 16 of 17 
Template Revision Date: December 1, 2023 
 
31. 
Haskell, W.L., et al., Physical activity and public health:  Updated 
recommendation for adults from the American College of Sports Medicine and 
the American Heart Association. Medicine & Science in Sports & Exercise, 2007. 
39(8): p. 1423-1434. 
32. 
Clarke, T., T. Norris, and J. Schiller, Early Release of Selected Estimates Based 
on Data from the 2016 National Health Interview Survey. 2017, National Center 
for Health Statistics. 
33. 
Temple, V.A., Factors associated with high levels of physical activity among 
adults with intellectual disability. International Journal of Rehabilitation Research, 
2009. 32(1): p. 89-92. 
34. 
Mahy, J., N. Shields, N. Taylor, and K. Dodd, Identifying facilitators and barriers 
to physical activity for adults with Down syndrome. Journal of Intellectual 
Disability Research, 2010. 54(9): p. 795-805. 
35. 
Chen, C.-C., T. Bellama, Y. Ryuh, and S. Ringenbach, Examination of 
participation and performance of dancing movement in individuals with Down 
syndrome. International Journal of Developmental Disabilities, 2019. 65(1): p. 58-
63. 
36. 
Ruiz-Muelle, A. and M.M. López-Rodríguez, Dance for people with Alzheimer’s 
disease: a systematic review. Current Alzheimer Research, 2019. 16(10): p. 919-
933. 
37. 
Zhu, Y., et al., Effects of aerobic dance on cognition in older adults with mild 
cognitive impairment: a systematic review and meta-analysis. Journal of 
Alzheimer's Disease, 2020. 74(2): p. 679-690. 
38. 
Lohman, T.G., A.F. Roche, and R. Martorell, Anthropometric standardization 
reference manual. 1988, Champaign,Ill: Human Kinetics Books. 
39. 
Agarwala, P. and S.H. Salzman, Six-Minute Walk Test: Clinical Role, Technique, 
Coding, and Reimbursement. Chest, 2020. 157(3): p. 603-611. 
40. 
Boer, P.H. and S.J. Moss, Validity of the 16-metre PACER and six-minute walk 
test in adults with Down syndrome. Disabil Rehabil, 2016. 38(26): p. 2575-83. 
41. 
Casey, A.F., X. Wang, and K. Osterling, Test-retest reliability of the 6-minute 
walk test in individuals with Down syndrome. Arch Phys Med Rehabil, 2012. 
93(11): p. 2068-74. 
42. 
Krinsky-McHale, S.J., et al., A modified Cued Recall Test for detecting prodromal 
AD in adults with Down syndrome. Alzheimer's & Dementia: Diagnosis, 
Assessment & Disease Monitoring, 2022. 14(1): p. e12361. 
43. 
McMurray, R.G., et al., Exploring metrics to express energy expenditure of 
physical activity in youth. PloS one, 2015. 10(6): p. e0130869. 
44. 
Kendzierski, D. and K.J. DeCarlo, Physical activity enjoyment scale: two 
validation studies. Journal of sport & exercise psychology, 1991. 13(1). 
45. 
Peterson, J.J., N. Andrew Peterson, J.B. Lowe, and F.K. Nothwehr, Promoting 
leisure physical activity participation among adults with intellectual disabilities: 
Validation of self‐efficacy and social support scales. Journal of applied research 
in intellectual disabilities, 2009. 22(5): p. 487-497. 
46. 
Croasmun, J.T. and L. Ostrom, Using likert-type scales in the social sciences. 
Journal of adult education, 2011. 40(1): p. 19-22. 

 
Page 17 of 17 
Template Revision Date: December 1, 2023 
 
47. 
Saunders, R.R., et al., Evaluation of an approach to weight loss in adults with 
intellectual or developmental disabilities. Intellect Dev Disabil, 2011. 49(2): p. 
103-12. 
48. 
Ptomey, L.T., et al., Remote Exercise for Adults with Down Syndrome. Transl J 
Am Coll Sports Med, 2018. 3(8): p. 60-65. 
49. 
Ptomey, L.T., et al., Weight management in adults with intellectual and 
developmental disabilities: A randomized controlled trial of two dietary 
approaches. J Appl Res Intellect Disabil, 2018. 31 Suppl 1: p. 82-96. 
50. 
Hojlo, M.A., A.L. Milliken, N.T. Baumer, and E.J. Davidson, DSFit: a feasibility 
pilot study of a group exercise programme for adolescents with Down syndrome. 
Journal of Intellectual Disability Research, 2022. 66(12): p. 952-966. 
51. 
Shields, N., et al., A 12-week exercise programme has a positive effect on 
everyday executive function in young people with Down syndrome: a pilot non-
randomised controlled trial. Journal of Intellectual Disability Research, 2022. 
66(12): p. 924-938.