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Behavioral Exposure Therapy for Exercise Intolerance (BE-FIT Trial)

Phase 2

Recruiting

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Medically approved cardiac rehabilitation

≥ 40 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a mechanism-informed behavioral intervention, BE-FIT, to target exercise anxiety in order to increase exercise outcomes. The intervention includes exposure to feared bodily sensations and exercise, prevention of safety behavior use, and use of a wrist-worn activity monitor for feedback and goal setting.

Who is the study for?

This trial is for individuals over 40 with high exercise anxiety, approved for cardiac rehab, and not very active. They must speak English and have no severe cognitive impairments or chronic conditions that could interfere with the study.

What is being tested?

The BE-FIT program aims to reduce exercise anxiety through exposure therapy, stopping safety behaviors around exercise, and using a wrist activity monitor. It's being compared to standard health education in a randomized-controlled trial.

What are the potential side effects?

There are no specific side effects mentioned for BE-FIT; however, as it involves physical activity and exposure therapy, participants may initially experience increased anxiety or discomfort during exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am enrolled in a heart health rehab program.

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I am 40 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall minutes of exercise

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Behavioral Exposure For Introceptive ToleranceExperimental Treatment1 Intervention

The BE-FIT intervention is a cognitive-behavioral intervention and is designed to target exercise anxiety. The three main 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 (Fitbit) for PA feedback and activity goal setting.

Group II: Health Education ControlActive Control1 Intervention

HEC is a time-matched control intervention that will be delivered on the same delivery schedule as BE-FIT. In this arm, participants will be provided educational information about health topics relevant to healthy aging delivered through PowerPoint lectures and handouts and use a Fitbit for PA monitoring.

0 / 2Eligibility criteria met