Acute Coronary SyndromeRESETNCT05099926
The Reducing Exercise Sensitivity With Exposure Training (RESET) Study
A study testing Reducing Exercise Sensitivity with Exposure Training in people with Acute Coronary Syndrome and Fear Anxiety, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Fear Anxiety, Physical Inactivity
- What is being tested?
- Reducing Exercise Sensitivity with Exposure Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2021to 3 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: The Reducing Exercise Sensitivity With Exposure Training (RESET) Study: Interoceptive Bias Reduction Training After Acute Coronary Syndrome
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome, Fear Anxiety, Physical Inactivity
- Being tested
- Reducing Exercise Sensitivity with Exposure Training
- Keywords
- Acute Coronary Syndrome, Exercise Sensitivity, Fear of Exercise, Cardiac Rehabilitation, Physical Activity
- Medical subject headings
- Acute Coronary Syndrome, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing Exercise Sensitivity with Exposure TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Reducing Exercise Sensitivity with Exposure Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Assessed after pilot study completion (approximately 4 weeks)
Secondary outcomes (2)
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 (sum of 18 items, each rated on a 0-4 Likert scale; score range: 0-72, with higher scores indicating greater fear of exercise).
Measured: baseline and after pilot study completion (4 weeks)
Change in Self-reported Physical Activity
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.
Measured: baseline and after pilot study completion (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start13 Oct 2021
- Primary completion27 Jan 2023
- Study completion3 Feb 2023
Why it stopped: Halted Prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Andrea Duran, Columbia University
- Investigators
- Andrea T Duran, PhD, Principal investigator, Columbia UniversityIan Kronish, MD, Study director, Florence Irving Associate Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099926
- Sponsor's protocol ID
- AAAT6275
- Other IDs
- P30AG064198
- Acronym
- RESET
- Status last verified
- Mar 2024
- First submitted
- 19 Oct 2021
- Last updated
- 4 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 1616469Farris 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.
PubMed 30801438Duran 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.
PubMed 31364434Kronish 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.
PubMed 28254185Amsterdam 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.
PubMed 25249585
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reducing Exercise Sensitivity With Exposure Training (RESET) Study: Interoceptive Bias Reduction Training After Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05099926
- Acronym / sponsor ID
- RESET / AAAT6275
- Conditions
- Acute Coronary Syndrome, Fear Anxiety, Physical Inactivity
- Keywords
- Acute Coronary Syndrome, Exercise Sensitivity, Fear of Exercise, Cardiac Rehabilitation, Physical Activity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted Prematurely
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Posted 4 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Reducing Exercise Sensitivity with Exposure Training | Experimental | Behavioral: Reducing Exercise Sensitivity with Exposure TrainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reducing Exercise Sensitivity with Exposure TrainingParticipants 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. | Behavioural | Reducing Exercise Sensitivity with Exposure Training |
Primary outcome
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).
2 secondary outcomes
Change in Exercise Sensitivity Questionnaire Score
Time frame: baseline and after pilot study completion (4 weeks)
Change in Self-reported Physical Activity
Time frame: baseline and after pilot study completion (4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1616469Eifert 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.
- Background: PubMed 30801438Farris 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.
- Background: PubMed 31364434Duran 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.
- Background: PubMed 28254185Kronish 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.
- Background: PubMed 25249585Amsterdam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea T Duran, PhD principal investigator
Columbia University
Ian Kronish, MD study director
Florence Irving Associate Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reducing Exercise Sensitivity with Exposure Training in people with Acute Coronary Syndrome and Fear Anxiety, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05099926, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.