Sustaining Physical Activity Following Cardiac Rehabilitation Completion
Phase: NA
Conditions: Cardiac Rehabilitation
Sponsor: University of North Carolina, Chapel Hill

 
Sustaining Physical Activity  
Following Cardiac Rehabilitation Completion 
 
 
 
NCT03991715  
Document Date: May 10, 2019  
 

Cardiac Rehabilitation (CR) Pilot Intervention (IRB #16-3306) 
CR Transition:  NC TraCS Grant 
 
Purpose:   
The proposed study will develop and pilot test an intervention to improve exercise adherence following 
completion of a supervised CR program.  This pilot intervention was informed by the interviews with program 
directors (IRB #16-2859) and focus groups conducted with cardiac rehab patients (IRB #16-3102).  To 
accomplish this, we will pilot the intervention with 5 CR participants, starting during CR and continuing with 
them as they transition out of the CR program. 
  
Participants 
We will recruit participants from local CR programs, with support from CR staff.  CR staff will identify 
participants that may be eligible and provide them with a flyer informing them of the study.  We will ask the CR 
staff to keep track of the number of flyers that are handed out, while UNC staff will track how many email 
inquiries are received, and finally the number who participate.  This information will be valuable for future 
studies.     
Participants are asked to contact the PI if interested, and then will be screened for eligibility by her.  The 
screening for eligibility will be based on a survey of questions that follow the inclusion and exclusion criteria 
below.  If eligible, or if requested before eligibility assessment, we will provide them with the consent form.  The 
inclusion and exclusion criteria have been developed to include a broad range of patients who graduate from 
CR.  To enhance the applicability of the results, the criteria are designed to be inclusive of patients with 
multiple comorbidities. 
Inclusion Criteria 
Eligible participants will: 
1. have a diagnosis of coronary heart disease 
2. currently attend outpatient phase 2 CR in a local CR program and have at least 4 weeks left before 
completion 
3. be >=18 years 
4. own a smart phone and ability to participate in a mobile health program with access to smartphones 
utilizing Apple or Android platforms   
5. be able to understand/write English   
6. adequate clinical stability achieved in the judgment of the investigator and referring CR staff to allow 
participation in study assessments and the intervention  
7. sign the informed consent document indicating that the patient understands the purpose of and 
procedures required for the study and is willing to participate in the study 
 
Exclusion Criteria 
These exclusion criteria were used from a similar study at Duke University (paper under submission).  They 
include: 
• 
Currently using a digital or non-digital physical activity tracker (Fitbit, Jawbone, pedometer, etc.) 
• 
Past use of a digital activity tracker (Fitbit, Jawbone, etc.)  past use of a pedometer is acceptable 
• 
Planned re-location within 12 weeks 
• 
Medical procedure scheduled within next 12 weeks 
• 
Acute symptoms of coronary artery disease  
• 
Decompensated heart failure 
• 
Severe valvular heart disease 
• 
Severe pulmonary hypertension 
• 
End stage renal disease 
• 
Heart failure, New York Heart Association (NYHA) class IV 
• 
Cardiac transplantation 
• 
Visually impaired 
• 
Current substance abuse 
• 
Impairment from stroke, injury, or other medical disorder that precludes participation in the intervention 
• 
Dementia that precludes ability to participate in and follow study protocols 

• 
Inability or unwillingness to comply with the study requirements 
 
Rationale and Risks 
Outpatient CR for coronary heart disease includes aerobic exercise and risk factor counseling and/or 
monitoring.  CR can slow or arrest coronary heart disease progression and reduce cardiac morbidity and 
mortality.  Most outpatient CR programs consist of up to 36 sessions of supervised aerobic exercise, after 
which patients are prescribed aerobic exercise on their own.  Unfortunately less than half of patients continue 
to exercise after CR completion. 
 
This project seeks to address this drop-off in exercise following CR, but incorporating an activity tracker into 
CR during the sessions to self-monitor themselves, and then allowing participants to continue using it following 
CR to monitor changes in their own exercise.  We believe the addition of an activity tracker is an intervention 
that does not pose greater than minimal risks to participants, with minimal risk defined as “the probability and 
magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered 
in daily life or during the performance of routine physical or psychological examinations or tests”. 
 
Recruitment Process 
We will recruit participants through local CR programs.  Initially, we will start with only one CR program, since 
our sample size for the pilot study is so small (n=5).  A flyer was created to provide the name of the project PI 
to contact by email about interest in participating.  If an email is received, a reply will be given to describe the 
study and send the informed consent document.  If the participant is interested in continuing, they will be asked 
to find a brief time to talk with study staff to make sure they are eligible.   
  
Participant Contacts and Timeline 
We will meet the participant at the CR facility to enroll them in the study, receive their signed consent 
document, provide them with a Fitbit activity tracker, and answer any questions.  We will provide the participant 
with our contact information, so that they can call or email us at any time with their questions.  We will also 
meet them at the CR facility when they have a final discharge meeting with CR staff, and at the end of the 
study.  At the discharge meeting, the CR staff will provide a list of dates/times to the UNC staff that the CR 
participant attended CR in order to document their attendance. 
 
The study timeline is as follows: 
- 
Approximately 2-4 weeks before completion of the CR program:  complete enrollment and survey 1; 
start wearing tracker 
- 
Receive weekly reports at CR regarding how tracking is progressing 
- 
At discharge (on or near their last day of CR), a study staff person will be present at this meeting; they 
will be asked to complete survey 2 
- 
The intervention kicks off at discharge with CR participants receiving a weekly contact with feedback on 
their progress and advice from peers on potential barriers to continuing physical activity  
- 
6 weeks post discharge: intervention ends 
- 
4 weeks later:  final contact with participant, complete survey 3, ask for any final feedback and 
disconnect from study tracking 
 
Email script to reply to those who inquire about participation 
Dear <name>,  
Thank you for your interest in participating in this research study.  We are seeking a few cardiac rehabilitation 
patients who are willing to wear an activity tracker during the course of the study, which starts during your 
cardiac rehabilitation program and continues for 10 weeks after discharge.  Our goal is to help you make a 
more successful transition from the cardiac rehabilitation program to exercising on your own. 
 
We could meet you at <name> Cardiac Rehabilitation Program either before or after one of your sessions to 
review the study procedures, answer any questions, and enroll in the study.  At that session, we will ask you to 
also complete a survey.  You would be asked to wear the activity tracker for the rest of your time in cardiac 
rehabilitation until the study ends about 10 weeks after cardiac rehabilitation.  For the first 6 weeks, we will 
provide feedback to you each week on how your exercise is progressing or maintaining since cardiac 
rehabilitation.  We would meet with you two other times and ask you to complete surveys at each time.  Your 

study participation would end at 10 weeks after cardiac rehabilitation, but you will be able to keep the activity 
tracker and continue to use it if you wish. 
  
Thanks in advance for your consideration, and I look forward to hearing from you.   
Sincerely, 
<name> 
<title> 
 
If interested:  Request to speak with them on the phone to check the eligibility criteria.  Send the patient the 
consent form.  If eligible and if a date is open, schedule with the patient. 
 
If not interested:   Do not contact participant again and thank them for their time. 
  
 
Items we will collect and keep on an Excel spreadsheet (password protected computer) 
Date of inquiry 
Location of CR program 
Name  
Contact information – address, phone, email 
Call notes 
Screening criteria: inclusion and exclusion criteria as listed in earlier sections 
Activity tracker number 
Assignment of ID 
Height and weight (to set-up the Fitbit) 
 
All research data collected from this study (Fitbit data, surveys) will be coded with the use of ID and not with 
any identifiers.  We will not retain identifiable information from the participants until they consent in the 
study.  We will keep track of the screening of eligibility, but will not keep name or contact information if they are 
deemed not eligible. 
  
Coordination Between UNC and RTI International (RTI) 
This proposal is unique in that it involves collaboration between UNC and RTI.  The division of responsibilities 
is as follows: 
- 
The recruitment and screening of participants for eligibility will be led by UNC.   
- 
RTI will set up the Fitbit accounts and take care of any technical issues related to Fitbit wear. 
- 
A RTI and UNC staff person will meet with the participant(s) together to instruct them on the wear and 
charging of the activity tracker.  Both will be available for any questions during the study. 
- 
RTI will monitor the Fitbit accounts during the course of the study. 
- 
Deidentified data from the activity tracker will be analyzed at both UNC and RTI. 
 
Description of the Fitbit Activity Tracker and Features 
Fitbit claims over 9.5 million active users.  This volume of adoption has permitted the company to test and 
apply various improvements to the core feature set and user-experience design based on actual user input that 
are far beyond the achievable within the scope of any research pilot.  Therefore, rather than pursue 
development of a de novo behavioral intervention, we will seek to leverage existing features of the Fitbit 
platform.   
 

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A fact sheet will be provided to help participants recall this information. 
 
3. Data collection  
Each participant will receive individual instruction and assistance installing the native Fitbit app on their Android 
or iPhone device.  Staff will assist with this process during the group training session.  The application will be 
configured to the study-assigned identifiers described in step one and be setup such that it will not obtain any 
additional information such as access to contacts, social platforms, or photos on the participants’ phones.  
Participants will be instructed to wear the Fitbit device as much and as consistently as possible throughout the 
study, removing the device only to shower, swim, and to charge when low battery is indicated.   
Specific recommendations from Evenson, et al (2015) will be delivered to participants, including: Wear the 
tracker in the same position each day; enter your details and sync; wear it on the non-dominant wrist; use add-
on features and obtain software updates, when available.  
 
4. Group  
A private Cardiac Rehab Group (CRG) has been created on Fitbit that is not publicly discoverable and can only 
be joined by invitation from study staff.  The CRG will only include the 5 participants recruited into the pilot and 
will be preconfigured using the devices setup for the study.  We will promote the use of messaging between 
the study staff and the individual participant.  The weekly message will include graphics on their physical 
activity over time, feedback on their progress with physical activity (Appendix 1), and graphics on any other 
behaviors they are tracking (weight, sleep, blood pressure, and glucose).  The message will also address any 
potential barriers to reaching their physical activity goals.  Participants will be able to email back to our staff 
with any questions.  We will record observations of individual and group platform interactions to characterize 
engagement and report as descriptive statistics.  The screen captures provide an example of the daily 
leaderboard and group features in the Fitbit platform and are for illustrative purposes only.   
 
Alternatively, if the participant does not receive emails via the group settings, then we will email the information 
directly.   
 
5. Fitbit Dashboard 
Our primary interest is in tracking physical activity and sedentary behavior.  However, we will give participants 
the option at any time to also track weight, sleep, blood pressure, and glucose (if diabetic).  We will provide 
them with weekly, and as data accumulates, month summaries of their weight, sleep, blood pressure, and 
glucose. 
 
Fitbit Dashboard and Reports 
Measure 
 
Display and Report Items 
 
 
Activities 
Steps, floors, calories burned, distance, logged common activities 
Weight  
 
Weight chart, Measurement history, Weight badges, 
Achievements 
Sleep 
Hours of sleep 
Blood pressure 
Systolic and diastolic blood pressure 
Glucose 
Glucose readings 
 
 
6. Data extraction  
Study staff will manually export data from the five accounts one time, at the end of the pilot for analysis.  Data 
will include physical activity metrics attributed to the study-assigned identifier and will not include any additional 
personal information on the user.   
 
7. Close-out  
On completion of the pilot (~10 weeks post CR discharge), participants will retain the Fitbit device and will be 
provided with instructions on how to convert registration from the study-assigned convention to create their 
own personal account.    

 
8. Time commitment 
 
Summary of Initial Training Session:  this session occurs with approximately 2-4 weeks left of CR for the 
participants (25 minutes) 
• 5 minutes to review the consent form, answer questions, and collect signed forms 
• 5 minutes to receive their assigned Fitbit when entering the study, review features of the tracker and how 
they will be used 
• 5 minutes to install the app to their phone 
• 10 minutes to complete survey 1  
 
During the Study 
• <1 minute to occasionally sync the Fitbit with the participant’s online account throughout the study 
• If RTI staff notice that the Fitbit is no longer being worn, then staff will contact the participant to inquire as to 
why 
 
At CR Discharge 
• Study staff will join in on this meeting between a CR staff person and patient in order to hear the discharge 
instructions and exercise advise given in order to support those goals after CR 
• 10 minutes to complete survey 2 
 
Summary of Close-out Session:  this session occurs when participants are 10 weeks from their CR program 
discharge date (15 minutes) 
• 5 minutes to disconnect the Fitbit from RTI-based accounts to leave the study  
• 10 minutes to complete survey 3  
 
  
Appendix 1:  Examples of general messaging by past experience (related to physical activity) using four 
groups.  These messages will be tailored to the participant’s progress. 
Group 1:  Goals are 
being met regularly 
and have had a 
successful past week 
Group 2:  Goals are 
being met regularly but 
they had an 
unsuccessful past week 
Group 3:  Goals are not 
being met regularly but 
they have had a 
successful past week 
Group 4:  Goals are not 
being met regularly 
and they are having an 
usuccessful past week 
You are on the right track! 
Keep staying strong. You 
will be on your way to a 
healthier new you! 
New activities can be 
challenging to do. Take it 
one day at a time!   
We know this is tough but 
stay strong!  
You are on your way to a 
healthier new you! 
If you’re having trouble, 
message a friend. This 
support will help keep you 
on track. 
Keep staying strong. We 
know it is not easy, but it 
is totally worth it. 
Hang in there! It could be 
worse. No one says it will 
be easy, but they do say it 
is worth it! 
You are going to set a 
great example for your 
spouse/partner, children, 
or other loved ones. 
Thank them in advance 
for helping you meet your 
goals. 
We know how you are 
feeling. Think about what 
you are gaining. Stay 
focused. It will get easier! 
There are so many 
benefits to exercise. Tell a 
friend what you look 
forward to most! 
Your journey to a healthy 
lifestyle might be a 
struggle, but looking back 
it will be well worth it. 
 
Tips for adding steps   
• 
Walk the dog with the whole family 

• 
Instead of calling friends, take a walk together to catch up. 
• 
Park your car as far away as possible so you have to walk a longer distance from your 
destination. Even better, walk or cycle to run errands. 
• 
Walk up and down the field while watching your child(ren) or grandchild(ren) play sports. 
• 
Replace a coffee break with an outdoor walk—or take the coffee with you on your walk. 
• 
Walk the golf course instead of using a cart. 
• 
Choose the stairs instead of the elevator or escalator. 
 
Keep Moving at Home & In the Community 
• 
Keep a list of quick activities, like squats or stretches, near the remote so that you can be active 
during commercial breaks. 
• 
Wash the car. 
• 
Plant and care for a vegetable garden (then cook the vegetables for healthy meals). 
• 
Start your day with a morning stretch or end your day with calming yoga 
• 
Sign up for dance lessons with a friend. 
• 
Experience the great outdoors and go for a hike, walk, or bike ride. 
 
 
  
 
Analysis Plan 
The following dates will be specified for analysis, corresponding to three time periods: 
- 
Pre-intervention: during cardiac rehabilitation starting on the day the activity tracker was given to the 
last day of cardiac rehabilitation (e.g., discharge) 
- 
Intervention: day following cardiac rehabilitation discharge to the day the last (sixth) report was sent 
- 
Maintenance: day following the last report to the last day of tracking by study staff 
 
The outcomes tested include physical activity (defined by the activity tracker as very active minutes/day) and 
steps per day. Independent variables include differences between study periods in terms of intercepts and 
slopes (i.e., as interaction terms). We will include days that have at least 500 steps, as days with less than 500 
steps probably indicate nonwear. Mixed model trajectory analysis will be used to test the effect of the 
intervention on the two outcomes.