Actively Recruiting

Phase 2
Age: 40Years +
All Genders
NCT05398276

Behavioral Exposure for Introceptive Tolerance RCT

Led by Rutgers, The State University of New Jersey · Updated on 2024-03-27

146

Participants Needed

2

Research Sites

221 weeks

Total Duration

On this page

Sponsors

R

Rutgers, The State University of New Jersey

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Behavioral Exposure for Introceptive Tolerance RCT

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 40 years of age or older
  • Elevated exercise anxiety with a score of 30 or higher on the Exercise Sensitivity Questionnaire (ESQ-18)
  • Low physical activity, defined as less than 90 minutes of moderate-to-vigorous intensity exercise per day in the past three months
  • Medically approved to participate in cardiac rehabilitation
  • Proficient in English
Not Eligible

You will not qualify if you...

  • Evidence of cognitive impairment, defined as a score of 23 or lower on the Montreal Cognitive Assessment (MoCA)
  • Severe disabling chronic medical or psychiatric conditions preventing safe or adequate participation
  • Expected inability to survive through the study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

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

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Research Team

S

Samantha G Farris, PhD

CONTACT

M

Mindy Kibbey, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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