The Reducing Exercise Sensitivity With Exposure Training (RESET) Study

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05099926
Study type	Interventional
Source	Columbia University
Contact
Status	Terminated
Phase	N/A
Start date	October 13, 2021
Completion date	February 3, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms