No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
40 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
146 (estimated)
Sponsor
Rutgers, The State University of New Jersey · Other
Who this trial is looking for
This trial is looking for people who have anxiety about exercising and are participating in cardiac rehabilitation. Participants will try a program that includes exposure to exercise-related fears and setting activity goals with a device that tracks their movements.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 40 years old.
I have elevated anxiety about exercise.
I do not engage in much exercise.
I have been cleared by my doctor for cardiac rehabilitation.
I can speak and understand English.
You may not be able to join if
I have significant issues with my thinking or memory.
I have a severe medical or mental health problem that affects my ability to take part in this study.
I am not expected to live through the study period.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 go…
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.
Trial Locations
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Status
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:
…
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
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