Actively Recruiting

Phase 2
Age: 40Years +
All Genders
ID05398276

A Tailored Exposure Intervention for Exercise Anxiety and Avoidance in Cardiac Rehabilitation

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

146

Participants Needed

2

Research Sites

N/A

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

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

Brief 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 ESQ-18
  • Less than 90 minutes of moderate-to-vigorous intensity physical activity 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...

  • Cognitive impairment with a score of 23 or lower on the Montreal Cognitive Assessment (MoCA)
  • Severe chronic medical or psychiatric conditions preventing safe participation
  • Expected life expectancy less than the duration of the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

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)

Follow-up Assessments

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)

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

M

Mindy Kibbey, MS

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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