Behavioral intervention to reduce exercise anxiety in cardiac rehabilitation patients
A Tailored Exposure Intervention for Exercise Anxiety and Avoidance in Cardiac Rehabilitation
This study is testing a new program to help people over 40 in cardiac rehab feel less anxious about exercising by gradually getting them used to the feelings that come with it.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 2 sites (East Brunswick, New Jersey and 1 other locations) |
| Trial ID | NCT05398276 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the Behavioral Exposure for Interoceptive Tolerance (BE-FIT), a behavioral intervention aimed at reducing exercise anxiety among cardiac rehabilitation patients aged 40 and older. The study involves 146 participants who will be randomly assigned to either the BE-FIT intervention or a health education control group. The intervention focuses on exposing patients to feared bodily sensations during exercise, preventing safety behaviors, and utilizing activity monitors for feedback. The trial aims to assess the efficacy of BE-FIT in improving exercise adherence and understanding the mechanisms behind any observed changes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 40 and older with elevated exercise anxiety who are enrolled in a medically approved cardiac rehabilitation program.
Not a fit: Patients with severe cognitive impairments or chronic medical conditions that prevent safe participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve exercise adherence and overall health outcomes for patients undergoing cardiac rehabilitation.
How similar studies have performed: Previous studies have indicated that behavioral interventions targeting exercise anxiety can be effective, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥ 40 years of age 2. Elevated exercise anxiety (score of ≥ 30 on ESQ-18) 3. Low active (\< 90 min self-reported moderate-to-vigorous intensity physical activity/day in past three months) 4. Medically approved cardiac rehabilitation 5. English proficiency Exclusion Criteria: 1. Evidence of cognitive impairment (≤ 23 on Montreal Cognitive Assessment; MoCA) 2. Severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevents safe or adequate participation 3. Expectation that patient will not live through study periods
Where this trial is running
East Brunswick, New Jersey and 1 other locations
- RWJ Cardiac Rehab at East Brunswick — East Brunswick, New Jersey, United States (Recruiting)
- Rutgers Emotion, Health and Behavior Laboratory Department of Psychology — New Brunswick, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Samantha G Farris, PhD
- Email: samantha.farris@rutgers.edu
- Phone: (845) 445-2174
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.