Last reviewed · How we verify
NCT05398276: BE-FIT
Behavioral Exposure for Introceptive Tolerance RCT
Phase 2 trial testing Behavioral Exposure For Introceptive Tolerance in Exercise Sensitivity in 146 participants. Currently enrolling.
31 July 2026
Quick facts
| Lead sponsor | Rutgers, The State University of New Jersey |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 146 |
| Start date | 3 May 2022 |
| Primary completion | 31 July 2026 |
| Estimated completion | 31 July 2026 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Behavioral Exposure For Introceptive Tolerance
- Health Education Control
Conditions studied
- Exercise Sensitivity — all drugs for Exercise Sensitivity →
- Introceptive Exposure — all drugs for Introceptive Exposure →
- Anxiety — all drugs for Anxiety →
- Cardiac Rehabilitation — all drugs for Cardiac Rehabilitation →
Sponsor
Rutgers, The State University of New Jersey
Who can join
40 and older, any sex, with Exercise Sensitivity or Introceptive Exposure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Confirmatory Factory Analysis of the Exercise Sensitivity Questionnaire (ESQ).
Farris SG, Kibbey MM, Derby L, Keller B, et al · · 2025 · PMID 40014001 · DOI 10.1097/hcr.0000000000000933
Verify or expand the search:
- PubMed search for NCT05398276
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05398276 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rutgers, The State University of New Jersey
- Last refreshed: 27 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05398276.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing