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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
BE-FIT Trial 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.Check my eligibility
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.See study design
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.
BE-FIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am enrolled in a heart health rehab program.
Select...
I am 40 years old or older.
BE-FIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall minutes of exercise
Secondary outcome measures
Objectively measured Lifestyle PA (steps/day).
Percent of prescribed cardiac rehabilitation attended.
BE-FIT 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.
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Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,086 Total Patients Enrolled
7 Trials studying Anxiety
1,423 Patients Enrolled for Anxiety
National Institute on Aging (NIA)NIH
1,674 Previous Clinical Trials
28,020,759 Total Patients Enrolled
12 Trials studying Anxiety
2,641 Patients Enrolled for Anxiety
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am enrolled in a heart health rehab program.It is expected that the patient will not survive during the study.You haven't been very active, doing less than 90 minutes of moderate-to-vigorous exercise each day in the past three months.You have problems with your memory and thinking abilities, as shown by a test called the Montreal Cognitive Assessment (MoCA) where you scored 23 or lower.You experience high levels of anxiety when it comes to exercise (scoring 30 or higher on a specific questionnaire).I am 40 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Behavioral Exposure For Introceptive Tolerance
- Group 2: Health Education Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Anxiety Patient Testimony for trial: Trial Name: NCT05398276 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks are associated with Behavioral Exposure For Introceptive Tolerance?
"Our team at Power assigned Behavioral Exposure For Introceptive Tolerance a score of 2 following our evaluation, as this is currently in the Phase 2 trial stage and has limited data supporting its safety but none proving efficacy."
Answered by AI
What is the uppermost cap on participants of this research trial?
"Affirmative. Clinicaltrials.gov states that this experiment is currently looking for participants, which was first listed on May 3rd 2022 and recently edited on the 26th of May. The study requires 146 subjects to be recruited between 2 distinct sites."
Answered by AI
Are there any openings for individuals to join this clinical trial?
"Correct. Per the information hosted on clinicaltrials.gov, this medical trial is recruiting participants with a start date of May 3rd 2022 and an update from May 26th 2022. 146 individuals need to be recruited across two sites for the study's success."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Missouri
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
What site did they apply to?
RWJ Cardiac Rehab at East Brunswick
Rutgers Emotion, Health and Behavior Laboratory Department of Psychology
Why did patients apply to this trial?
I'm tired of dealing with anxiety I'm 53 years old I've been dealing with it all my life and it just seems to be getting worse.
PatientReceived 2+ prior treatments
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