Lifestyle Physical Activity and Cognitive Training Interventions: Preventing Memory Loss in Older Women With Cardiovascular Disease
Phase: NA
Conditions: Cognitive Decline, Cardiovascular Diseases, Cognitive Dysfunction, Cognitive Impairment, Mild Cognitive Impairment
Sponsor: Rush University Medical Center

Lifestyle Physical Activity and Cognitive Training Interventions: 
Preventing Memory Loss in Older Women With Cardiovascular Disease 
 
NCT04556305 
 
01.26.2021 
 
 

MindMoves R01NR018443
Overall Protocol
1.26.2021
4.2 Study Design
A 2x2 factorial design will be used to test the separate and combined effects of two 
biobehavioral interventions: Move and Mind. A factorial design lets us examine the interactive 
effects of a multi-component intervention, in which the interactive effect of the combined 
intervention is greater than the sum of each of the intervention main effects.
In the 2x2 factorial design, participants are randomized to 1 of 4 combinations of the 2 
interventions being tested: (1) Move, (2) Mind, (3) MindMoves, and (4) usual care control. 
Move51,92,153–155,164–166 is a lifestyle physical activity program originally designed for community-
dwelling women, tested for feasibility in older women with CVD, and redesigned to meet their 
needs and preferences. Move includes a personal physical activity goal with self-monitoring and 
five group meetings over 24 weeks based on social cognitive theory. Mind is the 36-hour 
BrainHQ cognitive training program48,105,113,167,168 modified for delivery in a lifestyle-focused 
tablet form over 24 weeks.
Data collection appointments are conducted at baseline and post-intervention at 24 (D2), 48 
(D3), and 72 weeks (D4). Participants can continue to self-monitor steps in Move and will have 
access to the BrainHQ program in Mind following the end of the 24-week intervention. This will 
allow us to explore if continued use of these commercially available products predicts memory 
change, and to predict individuals more likely to maintain the physical activity and cognitive 
training. The usual care control group was selected to provide a comparison with older women 
not receiving the Move, Mind, or the combined MindMoves intervention.
4.2.a Narrative Study Description and Protocol
A. Introduction
The COVID-19 crisis has undoubtedly affected biobehavioral research. Older adults and those 
with chronic health problems are at greater risk for increased severity of symptoms and poor 
outcomes compared to younger populations or those without chronic health problems. Thus, 
our sample of women aged 65 years and older with cardiovascular disease (CVD) are 
considered a high-risk population during the current pandemic. We anticipate that we may face 
significant challenges if we were to follow the original protocol. Overall, our goal is to 
successfully fulfill the aims of the original proposed study, following the original timeline while 
keeping our participants and research staff safe. However, we realize that the current pandemic 
will have lasting effects for our patient population even as risk of infection declines. Our patient 
population may not feel comfortable coming to the clinic for study visits or attending in-person 
intervention group meetings despite the initial pandemic being over. Thus, we will have 
ORA: 18053104-IRB01   Date IRB Approved: 3/30/2020   Amendment Date: 1/26/2021

alternative methods that can enable our team to successfully conduct the study.  In this 
protocol, we will compare our original strategies versus the alternative strategies that will be 
utilized to decrease risk to patients throughout screening, data collection, and the intervention.  
Our alternative strategies aim to accommodate older women who may be at risk to leave the 
home after the current restrictions are lifted, or may feel more comfortable avoiding the clinic 
setting.
B. Recruitment and Screening 
Participants (N = 254) are women ≥ 65 years with CVD, who are recruited from the Rush Heart 
Center for Women (Center). The Center was the first heart program in Chicago devoted 
exclusively to women. There are two modes of entry into the study: (1) referral by the Center 
cardiology provider; (2) participants will self-refer for participation in the study after reviewing 
study materials posted at the Center clinic sites; and (3) patients who are 65 years or older, 
women, and have seen the Rush cardiology practice since March 2019 will be mailed letters 
introducing the study. All participants require approval from their cardiology provider. Approval 
will be obtained using the parmedx questions, that will be sent via redcap link in the Epic 
messaging. The parmedx allows providers to select if they approve of a patient’s participation in 
a moderate physical activity program. 
B1a. Original recruitment strategy. We will build on successful recruitment strategies used in 
our prior preliminary studies. Recruitment will proceed simultaneously at both sites. 
Dr. Halloway (PI) will conduct information sessions at the primary care recruitment sites (or via 
WebEx or Zoom virtual meetings) prior to the launch of the study. Information sessions will be 
conducted at regularly scheduled provider meetings and the information will be distributed via 
email. We expect these information sessions to last approximately 10-15 minutes. The content 
of the information sessions will include the purpose and procedures of the study and how to 
refer interested patients to the study team for additional introduction and screening. After the 
initial study information sessions, we will send out monthly email reminders regarding the 
study and attend quarterly staff meetings to reinforce referral processes. Dr. Volgman practices 
at both of the Center clinic recruitment sites. Dr. Halloway and Volgman will monitor 
procedures weekly. When a provider decides to make a referral to the study, they will provide 
the patient with a study information flyer and interest form. The providers will be instructed to 
explain to patients the purpose of the study, state that participation does not impact care 
received at the clinic, explain that data will not be associated to the electronic health record 
(EHR), and describe that they can receive more specific details regarding the study by 
completing the interest form.
Study information flyers will be posted in the waiting area and in the exam rooms of the Center 
clinic recruitment sites. The flyers and interest form will provide a description of the study and 
options for learning more about the study and expressing interest in participating. An interest 
form that includes the patient name, contact phone number, and best time to contact will be 
ORA: 18053104-IRB01   Date IRB Approved: 3/30/2020   Amendment Date: 1/26/2021

attached to the flyer. If patients do not wish to complete the interest form at that time, they 
can contact the study team by one of the other methods included on the information card (i.e., 
email or study phone number). Providers will communicate that participation in the study does 
not impact care received at the Center. Interested patients will be contacted by telephone by 
the study staff. During the first phone contact, the study staff will assess for preliminary 
eligibility of prospective patients for the study and set up a secondary, in-person screening 
appointment. 
Due to the current pandemic, we anticipate that patients may be less likely to schedule and 
come to the Center for their regular cardiology visits. Therefore, we propose an alternative 
strategy (option #3 above) in order to meet our recruitment goals. 
B1b. Alternative recruitment strategy. We will leverage an alternative recruitment strategy to 
capture patients that may not be pursuing in-person cardiology appointments and may not be 
utilizing telehealth throughout the current COVID-19 pandemic. The Rush Bioinformatics and 
Biostatistics Core (Core) regularly extracts Rush EHR data. Currently, inclusion/exclusion criteria 
for data extraction include the following: age (65 years and older), female sex, and a completed 
appointment with a RUSH cardiology provider since March 2019 (approximately one year prior 
to the Illinois stay-at-place order). This will allow us to efficiently identify current patients of 
Center cardiologists who are actively under the care of the providers.  EHR data elements to be 
regularly extracted may include all or a subset of the following: contact information (full names, 
address line 1 and line 2, city, state, zip, geographic coordinates if available, phone number(s), 
email address), demographics (date of birth, sex, race, ethnicity), current cardiology provider, 
vitals (height, weight, BMI, blood pressure, heart rate, etc.), diagnosis, drug prescriptions, and 
laboratory tests. The Core develops and assigns site and screening identification number for 
each patient in the data extraction(s). Data extraction results in spreadsheet(s) that include 
participant first and last name, associated screening ID, address, city, state, and zip code.    
Following Dillman’s methods for research and internet mailings, Dr. Volgman will send the 
identified patients a letter to introduce the study, present a summary of the interventions and 
procedures, provide the phone number and email for the research team, and inform that the 
patient can expect phone and email contacts from the research team.57 In these letters, Dr. 
Volgman will also state that patients can call or email the research team for additional 
information or if the patient does not wish to be contacted. After 10 days following the initial 
mailing, the research team will begin calling and emailing patients. This alternative recruitment 
strategy is being successfully employed in the ongoing nationwide U.S. POINTER trial (RUSH is a 
current U.S. POINTER sites). 
Recruitment begins when (1) the patient completes a paper or online interest form (indicating 
consent-to be-contacted), (2) the patient directly contacts the study staff indicating their 
interest in participating in the study, or (3) the patient identified by the EHR spreadsheet 
receives the recruitment letter in the mail. The paper forms will be kept at the front desk of the 
practice and kept in a sealed envelope. Study team members, not affiliated with the practices, 
will collect the interest forms. The study staff will conduct a preliminary telephone screening 
for all patients to assess eligibility for participation. A secure Microsoft Access database on the 
RUSH server will be used to track patient recruitment and communications.
ORA: 18053104-IRB01   Date IRB Approved: 3/30/2020   Amendment Date: 1/26/2021

B2a. Original screening protocol. 
Original preliminary screening. When screened for eligibility, we will assign an ID to the 
potential participant. Interested patients will be contacted by phone to receive an overview of 
the study and complete preliminary screening (age, English language fluency, cardiology 
provider, hearing loss, disability, Bluetooth capable device, current physical activity level, 
current cognitive activity level). Participants will also confirm best phone number for contact 
and an email address. If eligible following the preliminary screening, the interested patient will 
be scheduled for a secondary screening appointment in person. After the patient’s preliminary 
eligibility status is confirmed, a secondary screening appointment will be made. An electronic 
copy of the informed consent/authorization will be emailed to the participant. Staff data 
collectors will then schedule an in-person, secondary screening appointment with the data 
collectors to provide complete the secondary screening. They will be given a choice of meeting 
at a private room at RUMC or ROPH or a setting that is convenient to them.
Alternative preliminary screening. No changes.
Original secondary screening. At the beginning of the secondary screening appointment, the 
data collector will complete the informed consent and HIPAA research authorization process. 
The data collector will read the informed consent/authorization to the participant and the 
participant will have time to ask questions (10-15 minutes total). The informed consent and 
HIPAA research authorization process will be completed prior to any additional screening or 
data collection. During the informed consent and HIPAA research authorization process, 
participants will be asked for permission for the data collector to review the EHR for additional 
screening items. Following informed consent, participants will be screened for cognitive status 
(Montreal Cognitive Assessment), and will complete the Physical Activity Readiness 
Questionnaire. Data collectors will then review the EHR for the following criteria: diagnosis of 
CVD, blood pressure ≤ 160 or diastolic ≤ 100 mm Hg at the last clinic visit, hemoglobin A1C < 9.0 
in the past six months, no diagnosis of neurological disease, no stroke in the past three months, 
no stage 5 renal disease on dialysis, and medications (no anti-psychotics). 
If a participant is not eligible for the study based on secondary screening, the participant is 
considered as a screen failure. Eligible patients who agree to participate and are eligible at all 
stages of screening will complete baseline data collection appointments, either directly 
following secondary screening, or at a separate appointment in a private room at RUMC or 
ROPH. 
B2b. Alternative screening protocol. 
Alternative secondary screening. We will both mail a paper copy as well as email a digital copy 
of the informed consent/authorization form to the patient following a positive preliminary 
screening appointment. We will complete the secondary screening appointment over the 
phone instead of in-person. At the beginning of the secondary screening appointment, the data 
collector will verify the patient’s full name and date of birth to verify identify. Then the data 
collector will read the information consent/authorization to the participant, explaining all 
ORA: 18053104-IRB01   Date IRB Approved: 3/30/2020   Amendment Date: 1/26/2021

components, and the participant will be asked to read along to the paper copy they received in 
the mail and/or the electronic copy they received via email. The participant will have time to 
ask questions (10-15 minutes total for the informed consent/authorization process). The 
informed consent and HIPAA research authorization process will be completed prior to any 
additional screening or data collection. During the informed consent and HIPAA research 
authorization process, participants will be asked for permission for the data collector to review 
the electronic health record for additional screening items. The data collector will utilize the 
following smart phrase to document the informed consent process in Microsoft Access:
“On {Date and Time} the patient was consented for the {Title of study/Protocol number} 
study.  The protocol and consent form were reviewed with the patient, including the risks, 
benefits and alternative treatment options.  Time was given for questions to be asked and 
answered with the patient.  The patient demonstrated a good understanding of the study and 
participation.  The patient was given a copy of the signed consent prior to the start of study 
related procedures.  {Name of person consenting} consented this patient.”
In addition, the following checklist will be used to ensure that the data collector is fully 
discussing all components of the informed consent and authorization, including but not limited 
to purpose, procedures, risks/benefits, alternatives to participation:
INFORMED CONSENT PROCESS
DOCUMENTATION 
Subject ID:
____________________
ORA# 
Consent Version Date:  
Approval Date of Consent:
Expiration Date of Consent: 
Study Principal Investigator(PI)I:
Study Title:
Study and Consent discussed with:
___ Subject 
___ Legally Authorized Representative (LAR)
___ Family Members
___ Other
Key information presented to subject first?
     YES
     NO
Purpose of study discussed with subject?
     YES
     NO
Procedures discussed with subject?
     YES
     NO
Risks and Benefits discussed with subject?
     YES
     NO
All of subject’s or LAR’s questions were answered?
     YES
     NO
Subject or LAR verbalized understanding of consent?
     YES
     NO
ORA: 18053104-IRB01   Date IRB Approved: 3/30/2020   Amendment Date: 1/26/2021

Subject: 
 Agrees to Participate
                
 Declined Participation
                
 Wants to meet for further discussion
Consent signed prior to any study related procedures?
     YES
     NO
A copy of the executed study consent form was given 
to subject?
     YES
     NO
Is the subject currently enrolled in any other study?
     YES        
     NO
Does the subject have any special needs? If Yes, 
describe in comments section below
     YES
     NO
Does the subject meet all Inclusion and no exclusion 
criteria for the study?
     YES
     NO
Comments:
Signature of Person Obtaining Consent:
Date and Time: 
 
Following informed consent, participants will undergo secondary screening, including cognitive 
status (Montreal Cognitive Assessment) and will complete the Physical Activity Readiness 
Questionnaire. Data collectors will then review the electronic health record for the following 
criteria: diagnosis of CVD, blood pressure ≤ 160 or diastolic ≤ 100 mm Hg at the last clinic visit, 
hemoglobin A1C < 9.0 in the past six months, no diagnosis of neurological disease, no stroke in 
the past three months, no stage 5 renal disease on dialysis, and medications (no anti-
psychotics). In this alternative screening protocol, all of the secondary screening will occur over 
the phone. If a participant is not eligible for the study based on secondary screening, the 
participant is considered as a screen failure.
C. Data Collection and Intervention Orientation 
Participant tracking (phone calls, appointments completed, contact information) will be 
completed in Microsoft Access. The Access database will be password-protected and will be on 
the secure Rush server. Participants will complete informed consent procedures on the phone, 
and the informed consent process checklist will be recorded in Microsoft Access. Participants 
will complete all baseline survey measures using REDcap. All digital files will be saved using a 
unique identifier for each participant. The data collector will read all questionnaires to 
participants and administer the performance-based neurocognitive tests using an iPad tablet.
ORA: 18053104-IRB01   Date IRB Approved: 3/30/2020   Amendment Date: 1/26/2021

C1. Original Baseline (D1) Protocol. At the baseline (D1) appointments, participants will 
complete questionnaires, performance-based neurocognitive tests, and measurements of 
weight, height, and BP. Participants will wear an ActiGraph accelerometer on the hip to 
measure physical activity during waking hours for seven days, and then return the device to 
staff in a prepaid, padded envelope with tracking information. Return demonstration will be 
used to ensure proper accelerometer placement. Participants will receive a reminder text 
message and phone call two days following the data collection appointment to remind them to 
wear the accelerometer. Participants will have blood drawn at the outpatient laboratory after 
an 8-hour fast between 8am and 10am235 for serum biomarker levels and genotyping. 
C2. Alternative Baseline (D1) Protocol. Baseline appointments (D1) will have both phone and 
in-person components. First in-person data collection will be scheduled. The in-person data 
collection appointment will occur in the participants’ home. Prior to the in-person 
appointment, the data collector will ask if the participant or anyone that the participant is living 
with has symptoms of a respiratory infection including fever, shortness of breath, or cough. If 
the participant reports positive symptoms, then the in-person appointment will be rescheduled. 
The data collector will wear a gown, gloves, and mask to data collection appointments. At the 
in-person part of the appointment, participants will complete measurements of weight, height, 
BP, and step test, and the data collector will draw blood samples after an 8-hour fast between 
8am and 10am235 for serum biomarker levels and genotyping. Either at the outpatient 
laboratory or in the participant’s home, participants will prick their finger once to obtain 4 
blood spots (with additional pricks if necessary to obtain the 4 blood spots), and smear those 
blood spots on a card, also for serum biomarker levels and genotyping.  Both blood samples will 
be taken back to the Rush Biomarker Core for processing. Participants will wear an ActiGraph 
accelerometer on the hip to measure physical activity during waking hours for seven days, and 
then return the device to staff in a prepaid, padded envelope with tracking information. Return 
demonstration will be used to ensure proper accelerometer placement. Participants will receive 
a reminder text message and phone call two days following the data collection appointment to 
remind them to wear the accelerometer. Participants will be given a questionnaire response 
booklet that will be used during the phone data collection component.
Then phone data collection will consist of the data collector administering questionnaires and 
performance-based neurocognitive tests. 
C3. Randomization. Participants will then be randomized to a condition and complete 
intervention orientation by the interventionist. Because the Move intervention is group-based, 
all participants will be cluster-randomized by clinic recruitment site and will return to the same 
site five times over 24 weeks for group meetings. At the 24-, 48-, and 72-week data collection 
appointments, participants will return to the site to complete appropriate measures, wear the 
ActiGraph for seven days, and return it as described above. The data collector will be naïve to 
the randomization condition. Beginning in week 27 of Year 1, 7 weeks are allocated to recruit 
and complete baseline data collection appointments with 10-11 patients from each of the 2 
clinic recruitment sites (1–2 patients per site per week). Once all 10-11 participants have been 
recruited for a site, participants are randomized and told of their study condition (Move, Mind, 
ORA: 18053104-IRB01   Date IRB Approved: 3/30/2020   Amendment Date: 1/26/2021

MindMoves, and usual care control) at their respective intervention orientations. Recruitment 
then begins for the next cohort of 10-11 participants at each site.
C4. Intervention Orientation. Intervention Orientation will occur following randomization 
during a separate orientation appointment conducted by the interventionist. The Intervention 
Orientation will occur at a location convenient to the participant. In the alternative intervention 
orientation protocol, all appointments will occur at the participants’ homes, and contact will be 
minimized.
Original intervention orientation protocol. Participants receiving Move use their personal 
Bluetooth-capable device to self-monitor or track goals in the Fitbit application (app). 
Participants complete an individual intervention orientation with the interventionist, where the 
Fitbit is synced with their own device to track progress. Participants receive training on Fitbit 
use, its app, and troubleshooting. The interventionist uses a skills checklist to demonstrate 
correct use and have participants demonstrate their understanding. Written directions with 
pictures are provided. There will be a designated tech support staff member. The Fitbit is wrist-
worn during all hours except when swimming or bathing.158 Participants will first wear a Fitbit 
Charge HR with the monitor display blinded for seven consecutive days to obtain data for 
determining their initial goal. Interventionists will instruct participants to attend the five group 
meetings that occur in conference rooms at RUMC or ROPH. Participants receive weekly phone 
calls from interventionists to remind them to complete their intervention components. 
Participants will receive their first step and moderate-vigorous physical activity goals at Group 
Meeting 1.
Participants in Mind will complete the BrainHQ program on iPad tablets, which will be provided 
to them at the intervention orientation. Behavioral tracking is used to ensure each participant is 
trained at the threshold level (uppermost level of her skill). Training is tailored and progressive: 
exercises become increasingly complex as the participant progresses through the program at a 
rate specific to the individual. Participants will be introduced to the tablet, including general 
use, charging, and troubleshooting. Participants will be instructed to complete 30-minute 
BrainHQ training sessions 3 times per week over the course of 24 weeks. To ensure the 
participant is comfortable with the tablet and BrainHQ, the interventionist will demonstrate 
correct use, ask the participant to demonstrate correct use, and use a skills checklist. Written 
directions with pictures will be provided. We will have a tech support staff member.
Participants who are assigned to MindMoves will complete both the Move and Mind 
interventions simultaneously for 24 weeks. The 24-week MindMoves combined intervention 
will consist of: (1) 5 group meetings focusing on motivation and barriers to increasing physical 
activity, (2) physical activity goal with Fitbit monitoring, and (3) 30-minute home-based BrainHQ 
cognitive training sessions on an iPad tablet 3 times per week. Interventionists will complete 
orientation for both Move and Mind. Participants will receive both a Fitbit and tablet to 
complete the combined intervention.
ORA: 18053104-IRB01   Date IRB Approved: 3/30/2020   Amendment Date: 1/26/2021

Participants in the usual care control group do not receive any Mind- or Move-related 
intervention. At the Center, providers assess and counsel patients regarding self-management 
and lifestyle habits at every appointment and offer the following resources (standard clinical 
practice for patients with CVD143,205): (1) referral to a dietician; (2) cardiac rehabilitation for 
patients with a new qualifying diagnosis;206 (3) referral to a gym for weight management for 
obese patients; and (4) educational materials on risk management. Resources are offered per 
any change in CVD risk status. Patients are excluded in the intervention group if currently in a 
physical activity program or cardiac rehabilitation. The usual care condition is necessary 
because we hypothesize that Move alone and Mind alone will improve memory performance 
and serum biomarkers more than usual care.207 We do not expect issues with attrition in this as 
prior physical activity studies with usual care groups have comparable drop-out rates across 
conditions.89,208 There are no physical activity or cognitive training clinical guidelines specifically 
for older adults with CVD.143
Alternative Intervention Orientation Protocol. Intervention orientation content resembles the 
original intervention orientation protocol. However, Intervention Orientation will now occur in 
two stages to accommodate older women who may be at risk to leave the home after the 
current restrictions are lifted. For Move, the orientation intervention components requiring in-
person contact will occur in the home. The interventionist will sync a blinded Fitbit (to establish 
a physical activity goal), provide a participant manual, and give an iPad that will be used for 
virtual group meetings. Second, the interventionist will follow-up with the remainder of the 
orientation over the phone.  For the five group visits, the nurse interventionist will utilize the 
Zoom application to conduct a group meeting via video conference with the 10-11 other 
participants. The interventionist will follow the intervention manual for group meeting content 
and structure. For Mind, contact will be limited during the intervention orientation, which will 
occur in a participant’s home. First, the interventionist will drop off an iPad that the participant 
will utilize for the BrainHQ program and the participant manual. The iPad will be previously set 
up, and directions with pictures will be provided. The remainder of the intervention orientation 
will be conducted over the phone to minimize contact. 
Figure 1 displays the timeline of the delivery of the interventions (Mind, Move, MindMoves).
Figure 1. Timeline of Study Intervention Delivery
Intervention
Week
1
6
11
16
21
Mind: BrainHQ
30-minute sessions on tablet 3x/week
Move: Steps
Continuous self-monitoring of steps with Fitbit 
  Group meetings
1
2
3
4
5
Both: Phone calls
Weekly reminder phone calls
ORA: 18053104-IRB01   Date IRB Approved: 3/30/2020   Amendment Date: 1/26/2021

Participants will receive a $40 Target gift card at each data collection time point for a possible 
total of $160 in Target gift cards, and will either keep their Fitbit (Move, MindMoves) or receive 
a Fitbit (Mind, usual care).
C5 Follow-up Data Collection Appointments (D2, D3, D4)  
Original Follow-up Data Collection Protocol. Participants will complete questionnaires, 
performance-based neurocognitive tests, weight, height, and blood pressure. Similar to the 
baseline data collection appointments, participants will be read survey questions and data 
collectors will conduct the performance-based neurocognitive tests on an iPad. All measures 
will be collected except for the demographics and genetic factor measures. Participants will be 
given an ActiGraph accelerometer and instructed to wear the device on the hip during waking 
hours only for one week, and then will mail the device to the research staff using a prepaid, 
padded envelope with tracking information. Return demonstration will be used to evaluate 
proper accelerometer placement. Participants will receive a reminder text message and phone 
call two days following the data collection appointment to remind them to wear the 
accelerometer device. Participants will have their blood drawn at the outpatient laboratory at 
the respective clinic site (RUMC or ROPH) to obtain serum biomarkers and genetic factors.
Alternative Follow-up Data Collection Protocol. All measures will be collected during follow-up 
appointments except for the demographics and genetic factor measures. Participants will 
complete questionnaires over the phone with the data collector, including performance-based 
neurocognitive tests, weight, height, and blood pressure. Similar to the baseline data collection 
appointments, participants will be read survey questions and data collectors will conduct the 
performance-based neurocognitive tests. Then an in-person data collection appointment will be 
scheduled. The in-person data collection appointment will occur in the participant’s home. Prior 
to the in-person appointment, the data collector will ask if the participant or anyone that the 
participant is living with has symptoms of a respiratory infection including fever, shortness of 
breath, or cough. If the participant reports positive symptoms, then the in-person appointment 
will be rescheduled. The data collector will wear a gown, gloves, and mask to data collection 
appointments. At the in-person part of the appointment, participants will complete 
measurements of weight, height, BP, and step test, and the data collector will draw blood 
samples after an 8-hour fast between 8am and 10am235 for serum biomarker levels. Either at 
the outpatient laboratory or in the participant’s home, participants will also prick their finger 
once to obtain 4 blood spots (with additional pricks if necessary to obtain the 4 blood spots), 
and smear those blood spots on a card, also for serum biomarker levels. The samples will be 
taken back to the Rush Biomarker Core for processing. Participants will be given an ActiGraph 
accelerometer and instructed to wear the device on the hip during waking hours only for one 
week, and then will mail the device to the research staff using a prepaid, padded envelope with 
tracking information. Return demonstration will be used to evaluate proper accelerometer 
placement. Participants will receive a reminder text message and phone call two days following 
the data collection appointment to remind them to wear the accelerometer device.
ORA: 18053104-IRB01   Date IRB Approved: 3/30/2020   Amendment Date: 1/26/2021

4.2.c. Intervention Descriptions
Intervention Type:
Behavioral
Name:
Move
Description: 
The Move intervention is a 24-week evidence-based program based on social cognitive theory. 
It was originally developed for midlife women and successfully maintained increased physical 
activity. It has since been tailored for older women with CVD to prevent or delay memory, and 
includes: (1) education on the importance of lifestyle physical activity for brain health, (2) 
increasing lifestyle physical activity while considering CVD, and (3) including a goal for 
increasing Fitbit “active” minutes (≥ 3 METs or moderate-intensity physical activity) to ensure 
participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle 
physical activity. Core elements include a personal lifestyle physical activity goal and five group 
meetings. The personal physical activity goal is obtained from baseline steps and baseline 
“active” minute obtained from a Fitbit Charge HR 3 distributed during baseline data collection. 
Move group meetings, based on social cognitive theory, consist of five 90-minute visits led by a 
trained nurse interventionist.
Intervention Type: 
Behavioral
Name: 
Mind
Description: 
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training 
program. BrainHQ focuses on improving memory, sensory function, and working memory, and 
has demonstrated efficacy in improving memory among healthy older adults and adults with 
heart failure. BrainHQ is tailored to the individual, and program difficulty automatically 
progresses based on performance. BrainHQ addresses seven key core elements through six 
exercises that target memory, sensory function, working memory, and processing speed. 
Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants 
ORA: 18053104-IRB01   Date IRB Approved: 3/30/2020   Amendment Date: 1/26/2021

will complete the BrainHQ program on an iPad tablet, which will be provided to them. 
Behavioral tracking is used to ensure each participant is trained at the threshold level 
(uppermost level of her skill). Training is tailored and progressive: exercises become 
increasingly complex as the participant progresses through the program at a rate specific to the 
individual.
             
Intervention Type: 
Behavioral
Name: 
MindMoves
Description:
Participants who are assigned to this condition will complete both the Move lifestyle physical 
activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 
weeks. The 24-week MindMoves combined intervention will consist of: (1) five group meetings 
focusing on behavioral strategies to increasing moderate-intensity physical activity, (2) personal 
physical activity goal with Fitbit monitoring, and (3) three 30-minute sessions per week of 
home-based BrainHQ cognitive training sessions modified for use on an iPad tablet (see Move 
and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the 
combined MindMoves intervention.
ORA: 18053104-IRB01   Date IRB Approved: 3/30/2020   Amendment Date: 1/26/2021