Ignite Creation Date:
2024-05-06 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05099926
Status:
TERMINATED
Last Update Posted:
2024-04-04
First Post:
2021-10-19
Brief Title:
The Reducing Exercise Sensitivity With Exposure Training RESET Study
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
The Reducing Exercise Sensitivity With Exposure Training RESET Study Interoceptive Bias Reduction Training After Acute Coronary Syndrome
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Halted Prematurely
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESET
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 ie interoceptive exposure and interoceptive counseling and is designed to reduce exercise sensitivity ie 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 eg 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 ie 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 ie 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 investigators 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
To the investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30AG064198 | NIH | None | httpsreporternihgovquickSearchP30AG064198 |