The Reducing Exercise Sensitivity With Exposure Training (RESET) Study

NCT05099926 | Terminated Results

• 2 other identifiers: AAAT6275P30AG064198
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Fear Anxiety; Physical Inactivity

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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.

  Assessed after enrollment (baseline) and until pilot study completion (approximately 4 weeks)

• 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

  Assessed after pilot study completion (approximately 4 weeks)

• 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.

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

• 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).

  Assessed after pilot study completion (approximately 4 weeks)

• 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).

  Assessed after pilot study completion (approximately 4 weeks)

• 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).

  Assessed after pilot study completion (approximately 4 weeks)

Secondary Outcomes (2)

• Change in Exercise Sensitivity Questionnaire Score

  baseline and after pilot study completion (4 weeks)

• Change in Self-reported Physical Activity

  baseline and after pilot study completion (4 weeks)

Study Arms (1)

Reducing Exercise Sensitivity with Exposure Training

EXPERIMENTAL

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.

Behavioral: Reducing Exercise Sensitivity with Exposure Training

Interventions

Reducing Exercise Sensitivity with Exposure Training BEHAVIORAL

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.

Reducing Exercise Sensitivity with Exposure Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (5)

• 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.

  PMID: 1616469 BACKGROUND

• 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.

  PMID: 30801438 BACKGROUND

• 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.

  PMID: 31364434 BACKGROUND

• 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.

  PMID: 28254185 BACKGROUND

• 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.

  PMID: 25249585 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior

Results Point of Contact

• Title: Dr. Andrea T. Duran
• Organization: Columbia University Irving Medical Center

atd2127@cumc.columbia.edu

212-342-4491

Study Officials

• Andrea T Duran, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Ian Kronish, MD

  Florence Irving Associate Professor of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in the Department of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 29, 2021
• Study Start: October 13, 2021
• Primary Completion: January 27, 2023
• Study Completion: February 3, 2023
• Last Updated: April 4, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)