A Confirmatory Factory Analysis of the Exercise Sensitivity Questionnaire (ESQ).
Samantha G Farris, Mindy M Kibbey, Lilly Derby...
https://pubmed.ncbi.nlm.nih.gov/40014001/Actively Recruiting
Led by Rutgers, The State University of New Jersey · Updated on 2026-06-12
146
Participants Needed
3
Research Sites
N/A
Total Duration
This research aims to evaluate a behavioral intervention called Behavioral Exposure for Interoceptive Tolerance BE-FIT designed to reduce exercise anxiety in patients undergoing cardiac rehabilitation. The study is a Stage II randomized-controlled trial involving individuals aged 40 and older who have elevated exercise anxiety and are enrolled in a cardiac rehabilitation program. The goal is to determine whether BE-FIT improves exercise adherence and to understand the mechanisms behind any changes in physical activity behavior. Participants will be randomly assigned to one of two groups the BE-FIT intervention group or a health education control HEC group. BE-FIT includes six 45-minute individual sessions over three weeks, focusing on exposure to feared bodily sensations and exercise, preventing safety behaviors around exercise, and using a wrist-worn activity monitor Fitbit for feedback and goal setting. The HEC group receives time-matched educational sessions on healthy aging topics and also uses the Fitbit for monitoring physical activity but without set activity goals. Over 24 weeks, participants will engage in six sessions delivered twice weekly alongside their cardiac rehabilitation program. Data collection includes five assessments at baseline, end of treatment, and follow-ups at weeks 12, 18, and 24. Researchers will measure overall exercise minutes, attendance at cardiac rehabilitation, and daily steps. The study involves monitoring through questionnaires, Fitbit data, and clinical supervision to assess changes in exercise anxiety and adherence.
CONDITIONS
Behavioral Exposure for Introceptive Tolerance RCT
S
Samantha G Farris, PhD
I
Isabelle C Barb, BA
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Rutgers, The State University of New Jersey
Lead Sponsor
National Institute on Aging (NIA)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | BE-FIT Behavioral Exposure Program | Health Education Control |
|---|---|---|
| What it is | A 6-session, one-on-one behavioral intervention delivered with a clinician over three weeks. The program uses psychoeducation, repeated exposure to exercise and bodily sensations, reduction of avoidance/safety behaviors, and physical activity feedback via an activity tracker. The focus is on building tolerance for exercise and related discomfort. | A time-matched health education control intervention delivered over six sessions, scheduled alongside cardiac rehabilitation. Content includes general wellness topics such as nutrition, sleep, brain health, and other health information, with use of an activity tracker but no exercise goals or behavioral exposure tasks. |
| Role in this trial | Primary investigational intervention: developed to address exercise-related anxiety and avoidance during cardiac rehab. | Active comparator: controls for contact time and attention, isolates the specific contribution of behavioral exposure strategies. |
| Primary (intended) use | To improve exercise participation and tolerance in adults with elevated exercise anxiety by reducing avoidance and increasing engagement in cardiac rehabilitation. | To provide patients with general health-related education that is relevant to healthy aging during cardiac rehabilitation, with monitoring of physical activity but no behavioral change strategies for exercise tolerance. |
| How it is given or performed | Six 45-minute individual sessions over three weeks, conducted by a clinician in a one-on-one setting. Sessions are synchronized with the patient's scheduled cardiac rehabilitation visits. Includes psychoeducation, graded exposure exercises, and use of a physical activity tracker for monitoring and feedback. | Six 45-minute individual sessions over three weeks, delivered by an educator. Sessions overlap with cardiac rehabilitation appointments and cover educational topics through lectures and handouts, plus activity monitoring without explicit exercise goals. |
| Strength and maturity of evidence | Currently being studied in a randomized trial; results not yet reported. No published outcome data available as of now. Trial protocol and rationale published in peer-reviewed literature. | Active comparator included to control for time, attention, and education effect. No outcome data yet reported in the context of this specific program within cardiac rehabilitation for anxiety. |
| Important limitations | Efficacy and safety specifically for increasing exercise in anxious cardiac rehab patients are not yet established; results pending. The intervention is resource-intensive and requires clinician delivery. Generalizability beyond trial sites is unknown. | Serves as an attention and education control rather than clinical best practice for exercise anxiety. Does not address exercise avoidance or anxiety directly and might not affect those outcomes. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 weeks
Participants receive either the BE-FIT behavioral exposure program targeting exercise anxiety or a health education control program. Both include six 45-minute sessions delivered twice weekly over three weeks alongside cardiac rehabilitation. Participants use a Fitbit device for physical activity monitoring.
Six 45-minute sessions, twice weekly
Duration - 24 weeks
Participants complete assessments at baseline, end of treatment, and follow-ups at weeks 12, 18, and 24 to measure exercise adherence, anxiety levels, and physical activity.
Five assessment visits
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Samantha G Farris, Mindy M Kibbey, Lilly Derby...
https://pubmed.ncbi.nlm.nih.gov/40014001/Samantha G Farris, Mindy M Kibbey, Brittany Keller...
https://pubmed.ncbi.nlm.nih.gov/39389421/Rutgers, The State University of New Jersey
Lead Sponsor
National Institute on Aging (NIA)
Collaborating Sponsor