A Confirmatory Factory Analysis of the Exercise Sensitivity Questionnaire (ESQ).
Samantha G Farris, Mindy M Kibbey, Lilly Derby...
https://pubmed.ncbi.nlm.nih.gov/40014001Actively Recruiting
Led by Rutgers, The State University of New Jersey · Updated on 2024-03-27
146
Participants Needed
2
Research Sites
N/A
Total Duration
R
Rutgers, The State University of New Jersey
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
This research aims to evaluate a behavioral intervention called Behavioral Exposure for Interoceptive Tolerance (BE-FIT) designed to reduce exercise anxiety and improve exercise adherence in patients undergoing cardiac rehabilitation who are 40 years of age or older. The trial is a Stage II randomized-controlled study involving 146 patients with elevated exercise anxiety, aiming to understand if BE-FIT can help patients overcome anxiety to increase their physical activity during rehabilitation. Participants will be randomly assigned to either the BE-FIT intervention group or a Health Education Control (HEC) group. The BE-FIT program includes six one-on-one sessions over three weeks, focusing on exposure to feared bodily sensations, avoiding safety behaviors around exercise, and using a wrist-worn Fitbit to track and set physical activity goals. The HEC group receives matched contact time with educational sessions on healthy aging topics and also uses the Fitbit but without physical activity goals. Participants will attend six 45-minute individual sessions during the initial weeks of outpatient cardiac rehabilitation, scheduled before or after regular rehabilitation sessions. Assessments will be conducted at baseline, end of treatment, and at three follow-ups over 24 weeks. Researchers will collect data on exercise minutes, attendance at rehabilitation, and steps per day, monitoring progress and safety throughout the approximately six-month duration of the study.
CONDITIONS
Behavioral Exposure for Introceptive Tolerance RCT
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive 6 individual behavioral sessions over 3 weeks, delivered twice weekly. Sessions last approximately 45 minutes and coincide with cardiac rehabilitation appointments. Participants either undergo the BE-FIT cognitive-behavioral intervention targeting exercise anxiety or a Health Education Control intervention involving health education and Fitbit monitoring.
6 visits (in-person, twice weekly)
Duration - Up to 21 weeks after treatment
Participants complete assessments at the end of treatment and at three follow-up visits to monitor exercise adherence and physical activity outcomes over time.
4 visits (at baseline, end of treatment, Week 12, Week 18, and Week 24)
Total: 2 locations
1
RWJ Cardiac Rehab at East Brunswick
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
2
Rutgers Emotion, Health and Behavior Laboratory Department of Psychology
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
S
Samantha G Farris, PhD
M
Mindy Kibbey, MS
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