Acute Coronary Syndrome, Fear Anxiety, Physical Inactivity
Conditions
Keywords
Acute Coronary Syndrome, Exercise Sensitivity, Fear of Exercise, Cardiac Rehabilitation, Physical Activity
Brief summary
This study investigates the feasibility of conducting a home-based reducing exercise sensitivity with exposure training (RESET) intervention among acute coronary syndrome (ACS) survivors. RESET is an at-home, 2 visit intervention that involves psychoeducation, a brief, low-to-moderate intensity walking session (i.e., interoceptive exposure), and interoceptive counseling, and is designed to reduce exercise sensitivity (i.e., fear of exercise sensations) and improve participation in exercise-based secondary-prevention guidelines (cardiac rehabilitation and physical activity). The primary purpose of this pilot study is to test the feasibility, acceptability, and appropriateness of recruiting and administering the RESET intervention in ACS patients.
Detailed description
Fear of exercise may be prominent among acute coronary syndrome (ACS) survivors due to the presence of physical disease states that can exacerbate uncertainty about bodily sensations. 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 (i.e., exercise sensitivity). As a result, patients may avoid heart healthy activities, such as cardiac rehabilitation (CR) and physical activity, that prompt these physical sensations or terminate activities at the first sign of discomfort. Novel programs that target patient-level fears related to exercise sensations (i.e., exercise sensitivity) during the first-year post-discharge (the time window patients are eligible for CR) may be needed to improve CR participation and physical activity levels. To the investigator's knowledge, no intervention has been developed specifically to reduce exercise sensitivity in ACS survivors within the first year post-hospital discharge; a vulnerable population that is extremely sedentary, fails to meet physical activity guidelines, and with the most to gain from CR and physical activity participation. Thus, the investigator developed a de novo protocol for a reducing exercise sensitivity with exposure training (RESET) intervention.
Interventions
BEHAVIORALReducing Exercise Sensitivity with Exposure Training
Participants complete 2, home-based intervention visits on a secure video visit platform. Video visits include psychoeducation, interoceptive exposure, and interoceptive counseling. For homework, participants are asked to document their weekly physical activity and exercise sensations in a journal. Psychoeducation: Participants are educated about the benefits and safety of exercise and cardiac rehabilitation, the role of fear and anxiety in exercise avoidance, and the concept of interoceptive exposure. Interoceptive Exposure: A gradual six-minute walk (G6MW) serves as a low-risk form of interoceptive exposure. Exercise sensations and ratings of perceived intensity and distress are collected before and after the G6MW. Interoceptive Counseling: Participants review and reflect upon their pre-walking and post-walking physical sensations and ratings (intensity and distress) with a research team member. Homework is also reviewed.
Sponsors
National Institute on Aging (NIA)
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The intervention involves home-based psychoeducation, interoceptive exposure (walking), and interoceptive counseling administered by research personnel via video visits. Participants also complete weekly physical activity journals throughout the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older. * Speak and read English. * A diagnosis of acute coronary syndrome (ACS) based on ICD10 codes in the electronic health record within the past 12 months. * 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. * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Report Adequate Appropriateness of the Intervention | Assessed after pilot study completion (approximately 4 weeks) | The investigator will assess the percentage of participants who report scores ≥4 for their rating of the patient-perceived intervention's appropriateness on the Intervention Appropriateness Measure (average of 4 items, each rated on a 1-5 Likert scale; score range: 1-5, with higher scores indicating greater appropriateness). |
| Percentage of Participants Who Report Adequate Acceptability of the Intervention | Assessed after pilot study completion (approximately 4 weeks) | The investigator will assess the percentage of participants who report scores ≥4 for their rating of the patient-perceived intervention's acceptability on the Acceptability of Intervention Measure (average of 4 items, each rated on a 1-5 Likert scale; score range: 1-5, with higher scores indicating greater acceptability). |
| Percentage of Participants Who Report Adequate Feasibility of the Intervention | Assessed after pilot study completion (approximately 4 weeks) | The investigator will assess the percentage of participants who report scores ≥4 for their rating of the patient-perceived intervention's feasibility on the Feasibility of Intervention Measure (average of 4 items, each rated on a 1-5 Likert scale; score range: 1-5, with higher scores indicating greater feasibility). |
| Percentage of Participants That Are Adherent to the Intervention (Intervention Adherence) | Assessed after enrollment (baseline) and until pilot study completion (approximately 4 weeks) | As a measure of adherence, the investigator will assess the percentage of participants that complete a majority of the home-based RESET intervention visits. |
| Percentage of Participants Who Complete the Outcome Assessments Upon Program Completion | Assessed after pilot study completion (approximately 4 weeks) | This is to assess the feasibility of participants enrolled in the study to achieve outcomes assessments upon program completion |
| Percentage of RESET Sessions Administered as Intended | Assessed throughout administration of the pilot study (Up to 4 weeks) | As a measure of intervention fidelity, the investigator will assess the percentage of participants that had a majority of their home-based RESET intervention administered as intended as per completion of a fidelity checklist. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-reported Physical Activity | baseline and after pilot study completion (4 weeks) | The investigator will assess pre- to post-intervention change in physical activity using the short form International Physical Activity Questionnaire (IPAQ). The short form IPAQ is a 7-item, open-ended questionnaire eliciting participant's last 7-day recall of physical activity to assess the time spent in different physical activities (vigorous, moderate, walking) as part of their everyday lives. The outcome is an estimate of total physical activity in MET-min/week. |
| Change in Exercise Sensitivity Questionnaire Score | baseline and after pilot study completion (4 weeks) | The investigator will assess pre- to post-intervention change in exercise sensitivity using the Exercise Sensitivity Questionnaire (ESQ). The ESQ is an 18-item instrument designed to assess exercise sensitivity, specifically for use in adults with cardiac rehabilitation-qualifying conditions. Items reflect fear and anxiety of various bodily sensations and are rated from 0 to 4 (not at all to very much), based on agreement with each statement. Scores of all the items are summed to create a total score, where higher scores reflect more sever exercise sensitivity (sum of 18 items, each rated on a 0-4 Likert scale; score range: 0-72, with higher scores indicating greater fear of exercise). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reducing Exercise Sensitivity With Exposure Training Participants in this group complete 2, at-home reducing exercise sensitivity with exposure training (RESET) intervention visits with research-trained personnel via video visits. They complete psychoeducation, interoceptive exposure, followed by interoceptive counseling. Participants also complete weekly physical activity journals throughout the intervention. Each RESET intervention visits can occur once or twice per week over the course of 2 weeks, based on patient preference.
Reducing Exercise Sensitivity with Exposure Training: Participants complete 2, home-based intervention visits on a secure video visit platform. Video visits include psychoeducation, interoceptive exposure, and interoceptive counseling. For homework, participants are asked to document their weekly physical activity and exercise sensations in a journal.
Psychoeducation: Participants are educated about the benefits and safety of exercise and cardiac rehabilitation, the role of fear and anxiety in exercise avoidance, and the concept of interoceptive exposure.
Interoceptive Exposure: A gradual six-minute walk (G6MW) serves as a low-risk form of interoceptive exposure. Exercise sensations and ratings of perceived intensity and distress are collected before and after the G6MW.
Interoceptive Counseling: Participants review and reflect upon their pre-walking and post-walking physical sensations and ratings (intensity and distress) with a research team member. Homework is also reviewed. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Reducing Exercise Sensitivity With Exposure Training |
|---|---|
| Age, Continuous | 48.8 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Exercise Sensitivity | 28.0 score on a scale STANDARD_DEVIATION 11.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Percentage of Participants That Are Adherent to the Intervention (Intervention Adherence)
As a measure of adherence, the investigator will assess the percentage of participants that complete a majority of the home-based RESET intervention visits.
Time frame: Assessed after enrollment (baseline) and until pilot study completion (approximately 4 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reducing Exercise Sensitivity With Exposure Training | Percentage of Participants That Are Adherent to the Intervention (Intervention Adherence) | 3 Participants |
Primary
Percentage of Participants Who Complete the Outcome Assessments Upon Program Completion
This is to assess the feasibility of participants enrolled in the study to achieve outcomes assessments upon program completion
Time frame: Assessed after pilot study completion (approximately 4 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reducing Exercise Sensitivity With Exposure Training | Percentage of Participants Who Complete the Outcome Assessments Upon Program Completion | 3 Participants |
Primary
Percentage of Participants Who Report Adequate Acceptability of the Intervention
The investigator will assess the percentage of participants who report scores ≥4 for their rating of the patient-perceived intervention's acceptability on the Acceptability of Intervention Measure (average of 4 items, each rated on a 1-5 Likert scale; score range: 1-5, with higher scores indicating greater acceptability).
Time frame: Assessed after pilot study completion (approximately 4 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reducing Exercise Sensitivity With Exposure Training | Percentage of Participants Who Report Adequate Acceptability of the Intervention | 3 Participants |
Primary
Percentage of Participants Who Report Adequate Appropriateness of the Intervention
The investigator will assess the percentage of participants who report scores ≥4 for their rating of the patient-perceived intervention's appropriateness on the Intervention Appropriateness Measure (average of 4 items, each rated on a 1-5 Likert scale; score range: 1-5, with higher scores indicating greater appropriateness).
Time frame: Assessed after pilot study completion (approximately 4 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reducing Exercise Sensitivity With Exposure Training | Percentage of Participants Who Report Adequate Appropriateness of the Intervention | 2 Participants |
Primary
Percentage of Participants Who Report Adequate Feasibility of the Intervention
The investigator will assess the percentage of participants who report scores ≥4 for their rating of the patient-perceived intervention's feasibility on the Feasibility of Intervention Measure (average of 4 items, each rated on a 1-5 Likert scale; score range: 1-5, with higher scores indicating greater feasibility).
Time frame: Assessed after pilot study completion (approximately 4 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reducing Exercise Sensitivity With Exposure Training | Percentage of Participants Who Report Adequate Feasibility of the Intervention | 3 Participants |
Primary
Percentage of RESET Sessions Administered as Intended
As a measure of intervention fidelity, the investigator will assess the percentage of participants that had a majority of their home-based RESET intervention administered as intended as per completion of a fidelity checklist.
Time frame: Assessed throughout administration of the pilot study (Up to 4 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reducing Exercise Sensitivity With Exposure Training | Percentage of RESET Sessions Administered as Intended | 3 Participants |
Secondary
Change in Exercise Sensitivity Questionnaire Score
The investigator will assess pre- to post-intervention change in exercise sensitivity using the Exercise Sensitivity Questionnaire (ESQ). The ESQ is an 18-item instrument designed to assess exercise sensitivity, specifically for use in adults with cardiac rehabilitation-qualifying conditions. Items reflect fear and anxiety of various bodily sensations and are rated from 0 to 4 (not at all to very much), based on agreement with each statement. Scores of all the items are summed to create a total score, where higher scores reflect more sever exercise sensitivity (sum of 18 items, each rated on a 0-4 Likert scale; score range: 0-72, with higher scores indicating greater fear of exercise).
Time frame: baseline and after pilot study completion (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reducing Exercise Sensitivity With Exposure Training | Change in Exercise Sensitivity Questionnaire Score | 5.7 score on a scale | Standard Deviation 7.5 |
Secondary
Change in Self-reported Physical Activity
The investigator will assess pre- to post-intervention change in physical activity using the short form International Physical Activity Questionnaire (IPAQ). The short form IPAQ is a 7-item, open-ended questionnaire eliciting participant's last 7-day recall of physical activity to assess the time spent in different physical activities (vigorous, moderate, walking) as part of their everyday lives. The outcome is an estimate of total physical activity in MET-min/week.
Time frame: baseline and after pilot study completion (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reducing Exercise Sensitivity With Exposure Training | Change in Self-reported Physical Activity | 1203.8 change in MET-mins/week | Standard Deviation 1381.1 |