The Reducing Exercise Sensitivity With Exposure Training (RESET) Study (RESET)
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| ClinicalTrials.gov Identifier: NCT05099926 |
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Recruitment Status :
Terminated
(Halted Prematurely)
First Posted : October 29, 2021
Results First Posted : April 4, 2024
Last Update Posted : April 4, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Coronary Syndrome Fear Anxiety Physical Inactivity | Behavioral: Reducing Exercise Sensitivity with Exposure Training | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | The Reducing Exercise Sensitivity With Exposure Training (RESET) Study: Interoceptive Bias Reduction Training After Acute Coronary Syndrome |
| Actual Study Start Date : | October 13, 2021 |
| Actual Primary Completion Date : | January 27, 2023 |
| Actual Study Completion Date : | February 3, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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, and a brief walking activity (i.e., interoceptive exposure), followed by a session reflecting upon their walking experience with research-trained personnel (i.e., 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.
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Behavioral: 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. |
- Percentage of Participants That Are Adherent to the Intervention (Intervention Adherence) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Percentage of Participants Who Report Adequate Acceptability of the Intervention [ Time Frame: 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 [ Time Frame: 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 Who Report Adequate Appropriateness of the Intervention [ Time Frame: 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).
- Change in Exercise Sensitivity Questionnaire Score [ Time Frame: 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).
- Change in Self-reported Physical Activity [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05099926
| United States, New York | |
| Columbia University Irving Medical Center | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Andrea T Duran, PhD | Columbia University | |
| Study Director: | Ian Kronish, MD | Florence Irving Associate Professor of Medicine |
Documents provided by Andrea Duran, Columbia University:
| Responsible Party: | Andrea Duran, Assistant Professor in the Department of Medicine, Columbia University |
| ClinicalTrials.gov Identifier: | NCT05099926 |
| Other Study ID Numbers: |
AAAT6275 P30AG064198 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 29, 2021 Key Record Dates |
| Results First Posted: | April 4, 2024 |
| Last Update Posted: | April 4, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Acute Coronary Syndrome Exercise Sensitivity Fear of Exercise Cardiac Rehabilitation Physical Activity |
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Acute Coronary Syndrome Hypersensitivity Syndrome Disease Pathologic Processes |
Immune System Diseases Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |