Behavioral Exposure For Introceptive Tolerance for Cardiac Rehabilitation

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
RWJ Cardiac Rehab at East Brunswick, East Brunswick, NJ
Cardiac Rehabilitation+4 More
Behavioral Exposure For Introceptive Tolerance - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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 PA feedback and activity goal setting. Evidence from our 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). Our present aim is to conduct a Stage II randomized-controlled trial to further evaluate the efficacy of BE-FIT in decreasing exercise anxiety in CR patients and examine whether changes in this target yield successive changes in exercise adherence outcomes.

Eligible Conditions

  • Cardiac Rehabilitation
  • Anxiety
  • Introceptive Exposure
  • Exercise Sensitivity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cardiac Rehabilitation

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 24 weeks

24 weeks
Objectively measured Lifestyle PA (steps/day).
Overall minutes of exercise
Percent of prescribed cardiac rehabilitation attended.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Cardiac Rehabilitation

Trial Design

2 Treatment Groups

Health Education Control
1 of 2
Behavioral Exposure For Introceptive Tolerance
1 of 2
Active Control
Experimental Treatment

146 Total Participants · 2 Treatment Groups

Primary Treatment: Behavioral Exposure For Introceptive Tolerance · No Placebo Group · Phase 2

Behavioral Exposure For Introceptive Tolerance
Behavioral
Experimental Group · 1 Intervention: Behavioral Exposure For Introceptive Tolerance · Intervention Types: Behavioral
Health Education Control
Behavioral
ActiveComparator Group · 1 Intervention: Health Education Control · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks
Closest Location: RWJ Cardiac Rehab at East Brunswick · East Brunswick, NJ
Photo of new jersey 1Photo of new jersey 2Photo of new jersey 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Cardiac Rehabilitation
0 CompletedClinical Trials

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,348 Previous Clinical Trials
3,261,751 Total Patients Enrolled
1 Trials studying Cardiac Rehabilitation
374 Patients Enrolled for Cardiac Rehabilitation
Rutgers, The State University of New JerseyLead Sponsor
361 Previous Clinical Trials
60,041 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have been diagnosed with uterine leiomyoma and are ≥ 40 years of age.
You have elevated exercise anxiety.
You are active at least 90 minutes per day.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.