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The Reducing Exercise Sensitivity With Exposure Training (RESET) Study (RESET)

Primary Purpose

Acute Coronary Syndrome, Fear Anxiety, Physical Inactivity

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Reducing Exercise Sensitivity with Exposure Training

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Exercise Sensitivity, Fear of Exercise, Cardiac Rehabilitation, Physical Activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reducing Exercise Sensitivity with Exposure Training

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of participants that are adherent to the intervention (Intervention Adherence)

As a measure of adherence, the investigator will assess the proportion of participants that complete a majority of the home-based RESET intervention visits.

Proportion of participants who complete the outcome assessments upon program completion

This is to assess the feasibility of program completion

Proportion of RESET sessions administered as intended

As a measure of intervention fidelity, the investigator will assess the proportion of participants that had a majority of their home-based RESET intervention administered as intended as per completion of a fidelity checklist.

Proportion of participants who report adequate acceptability of the intervention

The investigator will assess the proportion of participants who report scores ≥4 for their rating of the patient-perceived intervention's acceptability on the Acceptability of Intervention Measure.

Proportion of participants who report adequate feasibility of the intervention

The investigator will assess the proportion of participants who report scores ≥4 for their rating of the patient-perceived intervention's feasibility on the Feasibility of Intervention Measure.

Proportion of participants who report adequate appropriateness of the intervention

The investigator will assess the proportion of participants who report scores ≥4 for their rating of the patient-perceived intervention's appropriateness on the Intervention Appropriateness Measure.

Secondary Outcome Measures

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.

Change in self-reported physical activity and sitting

The investigator will assess pre- to post-intervention change in physical activity and sitting 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) and sitting as part of their everyday lives. The outcome is an estimate of total physical activity in MET-min/week and time spent sitting.

Full Information

NCT ID

NCT05099926

First Posted

October 19, 2021

Last Updated

March 17, 2023

Sponsor

Columbia University

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT05099926

Brief Title

The Reducing Exercise Sensitivity With Exposure Training (RESET) Study

Acronym

RESET

Official Title

The Reducing Exercise Sensitivity With Exposure Training (RESET) Study: Interoceptive Bias Reduction Training After Acute Coronary Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Terminated

Why Stopped

Halted Prematurely

Study Start Date

October 13, 2021 (Actual)

Primary Completion Date

January 27, 2023 (Actual)

Study Completion Date

February 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome, Fear Anxiety, Physical Inactivity

Keywords

Acute Coronary Syndrome, Exercise Sensitivity, Fear of Exercise, Cardiac Rehabilitation, Physical Activity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reducing Exercise Sensitivity with Exposure Training

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Reducing Exercise Sensitivity with Exposure Training

Intervention Description

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.

Primary Outcome Measure Information:

Title

Proportion of participants that are adherent to the intervention (Intervention Adherence)

Description

As a measure of adherence, the investigator will assess the proportion 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)

Title

Proportion of participants who complete the outcome assessments upon program completion

Description

This is to assess the feasibility of program completion

Time Frame

Assessed after pilot study completion (approximately 4 weeks)

Title

Proportion of RESET sessions administered as intended

Description

Time Frame

Assessed throughout administration of the pilot study (Up to 4 weeks)

Title

Proportion of participants who report adequate acceptability of the intervention

Description

The investigator will assess the proportion of participants who report scores ≥4 for their rating of the patient-perceived intervention's acceptability on the Acceptability of Intervention Measure.

Time Frame

Assessed after pilot study completion (approximately 4 weeks)

Title

Proportion of participants who report adequate feasibility of the intervention

Description

The investigator will assess the proportion of participants who report scores ≥4 for their rating of the patient-perceived intervention's feasibility on the Feasibility of Intervention Measure.

Time Frame

Assessed after pilot study completion (approximately 4 weeks)

Title

Proportion of participants who report adequate appropriateness of the intervention

Description

Time Frame

Assessed after pilot study completion (approximately 4 weeks)

Secondary Outcome Measure Information:

Title

Change in Exercise Sensitivity Questionnaire Score

Description

Time Frame

baseline and after pilot study completion (4 weeks)

Title

Change in self-reported physical activity and sitting

Description

Time Frame

baseline and after pilot study completion (4 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea T Duran, PhD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ian Kronish, MD

Organizational Affiliation

Florence Irving Associate Professor of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Columbia University Irving Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

1616469

Citation

Eifert GH. Cardiophobia: a paradigmatic behavioural model of heart-focused anxiety and non-anginal chest pain. Behav Res Ther. 1992 Jul;30(4):329-45. doi: 10.1016/0005-7967(92)90045-i. Erratum In: Behav Res Ther 1993 Sep;31(7):711.

Results Reference

background

PubMed Identifier

30801438

Citation

Farris SG, Abrantes AM, Bond DS, Stabile LM, Wu WC. Anxiety and Fear of Exercise in Cardiopulmonary Rehabilitation: PATIENT AND PRACTITIONER PERSPECTIVES. J Cardiopulm Rehabil Prev. 2019 Mar;39(2):E9-E13. doi: 10.1097/HCR.0000000000000401.

Results Reference

background

PubMed Identifier

31364434

Citation

Duran AT, Ewing Garber C, Cornelius T, Schwartz JE, Diaz KM. Patterns of Sedentary Behavior in the First Month After Acute Coronary Syndrome. J Am Heart Assoc. 2019 Aug 6;8(15):e011585. doi: 10.1161/JAHA.118.011585. Epub 2019 Jul 31.

Results Reference

background

PubMed Identifier

28254185

Citation

Kronish IM, Diaz KM, Goldsmith J, Moise N, Schwartz JE. Objectively Measured Adherence to Physical Activity Guidelines After Acute Coronary Syndrome. J Am Coll Cardiol. 2017 Mar 7;69(9):1205-1207. doi: 10.1016/j.jacc.2016.10.087. No abstract available.

Results Reference

background

PubMed Identifier

25249585

Citation

Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):e344-426. doi: 10.1161/CIR.0000000000000134. Epub 2014 Sep 23. No abstract available. Erratum In: Circulation. 2014 Dec 23;130(25):e433-4. Dosage error in article text.

Results Reference

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The Reducing Exercise Sensitivity With Exposure Training (RESET) Study

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