The Reducing Exercise Sensitivity With Exposure Training (RESET) Study: Interoceptive Bias Reduction Training After Acute Coronary Syndrome
Phase: NA
Conditions: Acute Coronary Syndrome, Fear Anxiety, Physical Inactivity
Sponsor: Columbia University

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Protocol for Proposed Pilot Study: The Reducing Exercise Sensitivity with Exposure Training (RESET) 
Study 
NCT Number: NCT05099926 
Document Date: 1/26/2024 
 
 

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1. Study Purpose and Rationale  
 
Cardiac Rehabilitation (CR), an evidence-based, multi-disciplinary, standard of care program delivered in clinic- 
and/or home-based settings, has been shown to improve morbidity and mortality rates in Acute Coronary 
Syndrome (ACS) patients.1 Accordingly, CR is recognized as a Class I, Level A recommendation for secondary 
prevention by the American Heart Association (AHA) and American College of Cardiology (ACC).2 Despite its 
well-established effectiveness and safety, less than 30% of eligible cardiac patients participate in and adhere to 
CR programs in the United States.3 One potential, unexplored patient-level mechanism underlying poor 
participation in CR programs is fear of exercise. 
  
Fear of exercise may be prominent among ACS patients due to the presence of physical disease states that can 
exacerbate uncertainty about bodily sensations.4 For instance, patients may perceive physical sensations 
experienced during exercise (e.g., increased heart rate, shortness of breath, fatigue) as dangerous, intolerable, 
or similar to sensations experienced or attributed to their ACS, resulting in a fear of exercise sensations (e.g., 
exercise sensitivity).5 As a result, patients may avoid situations and activities, such as cardiac rehab and physical 
activity, that prompt these physical sensations or terminate activities at the first sign of discomfort.4-6 Novel 
programs that target patient-level fears related to exercise sensations (e.g., exercise sensitivity) during the first-
year post-discharge (the time window patients are eligible for CR) may be needed to improve CR enrollment 
(i.e., attendance at first CR visit), participation (i.e., overall number of CR visits) and physical activity levels. 
 
In our prior studies of ACS patients, we found indicators of exercise sensitivity to be a strong predictor of 
nonadherence to physical activity. When we asked about physical activity, ACS patients reported avoiding 
physical activity because they were afraid of experiencing rapid heart rate.7 A recent study demonstrated that 
more than 40% of cardiac patients attending CR reported fears about exercise and that these fears were 
associated with poorer clinical presentation at CR admission.6 Another study found that cardiac patients not 
attending CR reported higher levels of kinesiophobia (i.e., fear of movement) and exercise avoidance relative to 
their peers attending CR, suggesting that the most fearful patients may avoid CR attendance.8 Accordingly, fear 
of exercise may prevent eligible cardiac patients from attending and/or adhering to the CR programs and physical 
activity guidelines prescribed by their treating clinicians.  
To our knowledge, no intervention has been developed specifically to reduce exercise sensitivity in ACS 
survivors; a vulnerable population that is extremely sedentary, fails to meet physical activity guidelines, and with 
the most to gain from CR participation.2,9,10 Thus, we will develop a de novo protocol for a reducing exercise 
sensitivity with exposure training (RESET) intervention. We will model RESET on Anxiety Sensitivity Amelioration 
Training (ASAT).11 ASAT combines psychoeducation about the acute effects of interoceptive anxiety on the 
body, with behavioral exercises that are postulated to promote habituation to threatening interoceptive cues. 
These behavioral exercises (e.g., breathing into a paper bag to experience high CO2 concentration) involve 
repeated exposure to internal bodily cues that commonly cause distress, also known as interoceptive exposure.12 
The ASAT is delivered by video, and interoceptive exposure exercises are expected to be practiced at home- 
independent from monitoring.  
To develop our RESET intervention, we will modify the protocol of the aforementioned ASAT to target exercise 
sensitivity (vs. anxiety sensitivity) in ACS patients (vs. healthy adults), as well as use structured physical activity 
(vs. breathing into a paper bag) as a form of interoceptive exposure in home-based and community settings 
(Stage 1A: Intervention Development). We will then use an iterative human-centered design process to optimize 
the patient experience and maximize feasibility (Stage 1B: Feasibility). The purpose of this pilot study is to 
determine the feasibility (e.g., recruitment, adherence, fidelity), acceptability, and appropriateness of a RESET 
intervention in ACS patients. We will also explore pre- to post-intervention changes in exercise sensitivity and 
physical activity levels.  
 
2. Study Design  
An overview of the RESET pilot study design, including visits and research activity, is presented in Table 1. We 
will recruit 30 participants who survived an ACS event in the past 12 months. Participants will be contacted by 
research personnel via phone call to review the study, obtain verbal consent, and complete a brief set of 
screening questions to determine eligibility (Phone or Zoom Call Visit 1). Phone Call Visit 2 will include 
completion of baseline questionnaires and a cardiac rehabilitation interview. Phone Call Visit 2 can occur  

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 at the time of enrollment 
(Phone Call Visit 1) or within 1-
2 weeks after enrollment based 
on participant preference. The 
intervention setup video visit 
(Video Visit 1) will include 
download of the Fitbit app and 
setup of the Fitbit Inspire HR 
device, setup of the home 
environment, 
and 
a 
brief 
practice session to familiarize 
participants 
with 
the 
intervention visits, which will 
include 
psychoeducation, 
a 
brief, low-to-moderate intensity 
physical activity session (e.g., 
gradual 
six-minute 
walk 
[G6MW]), 
and 
interoceptive 
counseling. Participants will be 
guided in setting up their walking course as well as positioning their device with Zoom so that study staff can 
monitor them as they walk. If the participant’s home-environment is not conducive for proper monitoring of the 
G6MW, or they are uncomfortable displaying their home environment, they will be given the opportunity to 
complete the physical activity session by walking in place.  
The RESET intervention visits (Video Visits 2-3) will include psychoeducation (in Video Visit 2 only), a brief, 
low-to-moderate intensity physical activity session (e.g., gradual six-minute walk [G6MW]), and interoceptive 
counseling. Each RESET intervention visit will occur once or twice per week based on participant preference. 
All video visits will be conducted with research personnel via Zoom, an encrypted, HIPAA compliant, web-based, 
video-conferencing application. 
At the end of Video Visit 3, participants will be asked to complete post-intervention questionnaires. The post-
intervention questionnaires will include the same set of baseline questionnaires plus additional surveys to rate 
the acceptability, appropriateness, and feasibility of the intervention sessions. Lastly, to elicit feedback on the 
RESET design and assess the participant’s perceived barriers and facilitators to participating in the pilot study, 
the participant will also be asked to complete a 30-minute semi-structured exit interview, which will be completed 
on the telephone and will be audio recorded using the Zoom platform on a separate device with participants on 
speaker phone with research personnel.  
3. Study Procedures  
Eligibility Criteria: A total of 30 acute coronary syndrome (ACS) patients who report at least some fear of 
exercise will be offered an opportunity to enroll in the RESET study.  
 
Patients will be included if they meet the following inclusion/exclusion criteria:  
 
Inclusion Criteria:  
• 
Age 18 years or older 
• 
Speak and read English  
• 
A diagnosis of ACS based on ICD10 codes in the electronic health record within the past 12 months. 
ACS events will be defined according to American Heart Association/American College of Cardiology 
criteria as either non-ST-elevation myocardial infarction (NSTEMI), ST-elevation myocardial infarction 
(STEMI), or unstable angina (UA).2  
o Corresponding ICD10 codes for criteria above: I20.__ (i.e., I20.0, I20.9), I21.__ (i.e., I21.3, 
I21.4, I21.02, I21.29, I21.9), Z95.__ (i.e., Z95.1, Z95.5), Z98.61 
Table 1. Overview of Study Design 
Visit Type 
Research Activity 
Duration  
Mode 
Phone (or Zoom) 
Call Visit 1 
1. Participant consent and enrollment 
15-30 mins 
Phone 
Zoom  
Phone Call Visit 2 
1. Pre-Intervention Preparation 
a. Baseline Questionnaires 
b. Cardiac Rehabilitation Interview 
 
20 mins 
30 mins 
Phone 
 
Video Visit 1 
1. Intervention Setup 
60-90 mins 
Zoom 
Video Visit 2 
1. Intervention visit 
a. Psychoeducation 
b. Interoceptive exposure 
c. Interoceptive counseling 
 
30 mins 
15 mins 
10-20 mins 
Zoom 
Video Visit 3 
1. Intervention visit 
a. Interoceptive exposure 
b. Interoceptive counseling 
 
15 mins 
10-20 mins 
Zoom 
Video Visit 3 
Continued 
1. Post intervention visit 
a. Post-intervention questionnaires 
 
20 mins 
 
Zoom or 
Phone 
Phone Call 3 
2. Exit Interview 
30-45 mins 
Phone 

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• 
Scored >1 (sometimes, often, or very often) on at least one item from the Aversive Cognitions about 
Physical Activity Scale and/or scored >1 (some, much, or very much) on at least one item from the 
Exercise Sensations Questionnaire. 
• 
Owns either a tablet or smartphone (iPhone or Android) to conduct Zoom video visits 
• 
Express interest in participating  
 
Exclusion Criteria:  
• 
Severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis 
that prevent safe or adequate participation, such as: 
o Staged percutaneous coronary intervention (PCI) with significant remaining lesion 
o Decompensated heart failure (NYHA IV) 
o Untreated or unstable non-sustained or sustained ventricular and/or atrial arrhythmias 
o Recurrent syncope without definitive diagnosis and/or presently undergoing workup 
o Symptomatic valvular disease 
o Uncontrolled hypertension (SBP>200 mmHg or DBP>100 mmHg) 
o High level of silent ischemia (ST-segment depression ≥2 mm from baseline) 
• 
Unable to comply with the protocol (either self-selected or indicated during screening that s/he/they could 
not complete all requested tasks) for reasons that include, but are not limited to, patients with a level of 
cognitive impairment indicative of dementia, patients with current alcohol or substance abuse, patients 
with a significant movement disorder that interferes with walking, and patients with severe mental illness 
(e.g., schizophrenia) 
• 
Unavailable for follow-up for reasons such as terminal illness and imminent plans to leave the United 
States (as we have migrant or mobile patients due to their citizenship and work issues). 
 
Study staff will confirm that the participant meets all inclusion/exclusion criteria for the study. Once consented 
and enrolled, the participants’ EHR will be accessed, to further confirm study eligibility. 
 
Recruitment and Enrollment (Phone or Zoom Call Visit 1): For the purpose of this study, we will recruit 
patients who survived an ACS event in the past 12 months. Potential participants for this pilot study will be 
identified in several ways: (1) referral from treating clinicians (e.g., physicians, physician assistants, physical 
therapists), (2) research studies at our Center where participants with ACS ICD-10 codes agreed to be contacted 
about future study opportunities, and (3) electronic health record data pulls of individuals hospitalized at 
NYPH/CUIMC in the past year, followed by physician approval to contact the patient. 
 
After patient information is confirmed, research personnel will contact potential participants via telephone (Phone 
or Zoom Call Visit 1) to review the study and obtain verbal informed consent to be enrolled and screened for 
participation in the pilot study. The verbal consent will include details about being screened for eligibility as well 
as overall study participation. If the patient agrees, a member of the research team will ask a brief series of 
questions to assess study eligibility. Sociodemographic factors will include age, gender, race, ethnicity, height, 
weight, marital status, education, work history, social support, and home/mailing address. Questions will include 
topics such as internet access, electronic devices, home-based environment and resources, cardiac 
rehabilitation participation, and administration of an 18-item Exercise Sensations Questionnaire (ESQ), 
specifically designed for use in adults with CVD and CR-qualifying conditions6 as well as  the Aversive Cognitions 
about Physical Activity Scale; a four-item questionnaire to assess patient fear and avoidance of exercise.7 If the 
participant has internet access, an electronic device with web-based capabilities, adequate space to conduct 
home-based exercise, and scores >1  on at least one fear of exercise question (from the ESQ or Aversive 
Cognitions about Physical Activity Scale), then the participant will be deemed eligible for the study. If the 
participant does not meet the eligibility criteria, the participant will be withdrawn from the study and thanked for 
their time.  
 
Pre-Intervention Preparation (Phone Call Visit 2 and Video Visit 1): A member of the research team will meet 
with the participant on a secure phone line to conduct a series of pre-intervention preparation components, which 
includes a set of baseline questionnaires  and a cardiac rehabilitation interview (Phone Call Visit 2 [50-60 mins]). 
The interview will be audio recorded using the Zoom platform on a separate device with participants on speaker 

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phone with research personnel. Once the questionnaire and cardiac rehabilitation interview is concluded, 
research personnel will meet with the participant via the Zoom Video Visit platform to conduct intervention setup 
(Video Visit 1 [60-90 mins]). Participants will receive a PayCard in the mail following the last preparation visit 
onto which compensation will be loaded for this and future visits. Details of each component are provided below. 
 
RESET Intervention (Video Visit 2-3): A member of the research team will meet with the participant on a secure 
Zoom Video Visit platform to conduct a total of 4 RESET intervention video visits. Each RESET intervention 
video visit will occur once or twice per week based on participant preference. The first intervention visit (Video 
Visit 2 [60 mins]) will include psychoeducation, interoceptive exposure (i.e., G6MW), and interoceptive 
counseling. At the end of Video Visit 2, participants will complete a series of valid, reliable, and pragmatic 4-item 
surveys designed to assess the acceptability, appropriateness, and feasibility of the RESET program, as well as 
the satisfaction of each intervention component and design feedback (e.g., psychoeducation, interoceptive 
exposure, interoceptive counseling.13 The other intervention visit (Video Visit 3 [30 mins]) will include 
interoceptive exposure (i.e., G6MW) and interoceptive counseling. At the end of the last intervention visit (Video 
Visit 3), participants will complete post-intervention questionnaires and an exit interview. Following the last 
intervention visit, additional compensation will be loaded onto the participant’s PayCard. Details of each RESET 
intervention component are provided below. 
 
Post-Intervention (Video Visit 3 Continued and/or Phone Call 3): After completing the last RESET 
intervention visit (Video Visit 3), participants will be asked to complete the post-intervention questionnaires (20 
mins), which will take place on the same secure Zoom Video Visit platform as Video Visit 3 or a at a separate 
date and time based on participant preference. Participants will also be asked to complete the semi-structured 
exit interview, which will take place via telephone (Phone Call 3 [30 mins]). To accommodate participant 
preference, participants will be given the option to complete the exit interview phone call immediately following 
the last RESET intervention visit or at a separate day and time.  
 
After all intervention sessions are complete, the participant will be given the option to keep their devices or 
receive a pre-paid package to mail back the devices. 
 
3. Compensation 
Participants will receive a Bank of America PayCard in the mail after successfully completing the initial/first video 
visit (60 minutes). Once they confirm receiving the PayCard with study personnel, $50 will be uploaded to the 
card as compensation for the pre-intervention preparation video visit. Following successful completion of the 
intervention video visits (2 and 3), post-intervention questionnaires, and audio-recorded exit interview, they will 
be compensated an additional $100 on the PayCard. Therefore, the total possible compensation for completing 
the study is $150. All compensation is loaded onto one Bank of America PayCard registered specifically to the 
participant.     
In addition, participants will be permitted to keep the study-provided heart rate monitor and physical activity 
tracker (Fitbit Inspire HR) upon completion of the study, which has an estimated value of $100.00 when 
purchased as new. 
4. Risks 
There are minimal risks associated with participation in moderate-intensity bouts of physical activity including 
injury or medical complications. Evidence-based secondary prevention guidelines strongly recommend that post-
ACS patients achieve ≥30 minutes of moderate aerobic activity, such as brisk walking, on ≥5 days per week 
within 2 weeks of hospital discharge.14 The most common injuries include muscle strains, joint sprains, and bone 
injuries. During moderate-intensity physical activity, heart rate and blood pressure may increase. In rare cases 
(risk approximately equal to one event in 60-80,000 hours of supervised patient exercise: ACSM, 2007), this can 
lead to a serious cardiac event. Only patients deemed medically appropriate for participation will be enrolled in 
the study. The current RESET intervention will use short bouts (6 mins) of low-to-moderate-intensity physical 
activity, which is well BELOW the intensity and volume of the evidence-based guidelines. Moreover, patients 
give biofeedback during treatment to ensure that exercise is occurring at the appropriate intensity. Therefore, 
the risk of the study intervention is minimal.  

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Psychological Distress: The questionnaires pose modest risk of psychological discomfort. Patients may 
experience a range of sensations during exposures (e.g., muscle tightness, increased heart rate, shortness of 
breath). These symptoms are temporary, and while there is risk for experiencing these sensations, engagement 
in exposure techniques and physical activity is the treatment for anxiety and exercise is also critical for heart 
health. Thus, while intervention techniques can initially elicit possible anxiety/physical discomfort, repeated 
practice and engagement will actually serve to decrease anxiety and increase tolerance for exercise. 
Loss of Confidentiality: A potential risk from this study is the violation of the participant’s privacy, since patient 
medical information will be used as a source of data. We have measures in place to protect participant privacy 
and confidentiality.  
A clinical psychology scientist, exercise physiology scientist, and internal medicine physician will be on-call 
during video visits to provide study personnel with assistance if participants experience any distressing thoughts 
or feelings during their participation in this pilot study. 
5. Benefits 
Participants may not receive any benefit from study participation. 
Improved psychological symptoms and adherence to the medical regimen: Participants may benefit in terms of 
decreased symptoms of fear and anxiety related to their ACS. This may help participants be more adherent to 
their medical treatments including exercise. Participants may also benefit from the attention they receive from 
study personnel.  
Contributions to knowledge: While participants in this study may not directly benefit from their participation, we 
anticipate results from this study to benefit future research that seeks to reduce fear and improve health 
behaviors after acute cardiovascular events. 
6. Alternatives 
The alternative is not to participate in the study. Additionally, the Principal Investigator may withdraw 
participants from the study after enrollment upon further examination of eligibility criteria and/or at their 
professional discretion. 
7. Data and Safety Monitoring 
As this study presents minimal risk to participants, data and safety monitoring will be conducted by the study 
staff as directed by the principal investigator.  Investigators and research assistants will meet weekly to discuss 
any issues or concerns with the study, in particular, whether there were any unexpected complaints about the 
study procedures or questionnaires, or whether there were any breaches in data confidentiality (which will be 
reported to the IRB as required by policy). If unexpected complaints about the procedures or questionnaires are 
generated, then the study may be stopped or altered prior to recruiting the full sample.  
 
 
 

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