NCT05398276 Behavioral Exposure for Introceptive Tolerance RCT
| NCT ID | NCT05398276 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Exercise Sensitivity |
| Study Type | INTERVENTIONAL |
| Enrollment | 146 participants |
| Start Date | 2022-05-03 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 146 participants in total. It began in 2022-05-03 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Behavioral Exposure for Interoceptive Tolerance (BE-FIT) is a mechanism-informed behavioral intervention to target exercise anxiety. The three primary components of BE-FIT include: (1) exposure to feared bodily sensations and exercise; (2) prevention of safety behavior use before/during/after exercise, and (3) use of a wrist-worn activity monitor for physical activity (PA) feedback and activity goal setting. Evidence from the investigators' Stage I trial indicated that BE-FIT is feasible, acceptable, and safe and produced reductions in exercise anxiety and increased exercise outcomes (short-term moderate-to-vigorous intensity physical activity and steps/day). The investigators' present aim is to conduct a Stage II randomized-controlled trial to further evaluate the efficacy of BE-FIT in decreasing exercise anxiety in cardiac rehabilitation (CR) patients and examine whether changes in this target yield successive changes in exercise adherence outcomes.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05398276 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Exercise Sensitivity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05398276 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05398276 currently recruiting?
Yes, NCT05398276 is actively recruiting participants. Contact the research team at samantha.farris@rutgers.edu for enrollment information.
Where is the NCT05398276 trial being conducted?
This trial is being conducted at East Brunswick, United States, New Brunswick, United States.
Who is sponsoring the NCT05398276 clinical trial?
NCT05398276 is sponsored by Rutgers, The State University of New Jersey. The trial plans to enroll 146 participants.