Exercise SensitivityBE-FITNCT05398276
Behavioral Exposure for Introceptive Tolerance RCT
A study testing Behavioral Exposure For Introceptive Tolerance in people with Exercise Sensitivity and Introceptive Exposure, run by Rutgers, The State University of New Jersey at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Exercise Sensitivity, Introceptive Exposure, Anxiety
- What is being tested?
- Behavioral Exposure For Introceptive Tolerance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 May 2022to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 40 years of age
- Elevated exercise anxiety (score of ≥ 30 on ESQ-18)
- Low active (< 90 min self-reported moderate-to-vigorous intensity physical activity/day in past three months)
- Medically approved cardiac rehabilitation
- English proficiency
Who cannot join
- Evidence of cognitive impairment (≤ 23 on Montreal Cognitive Assessment; MoCA)
- Severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevents safe or adequate participation
- Expectation that patient will not live through study periods
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
RWJ Cardiac Rehab at East Brunswick
East Brunswick, New Jersey, 08816
Victoria Larkin, DPT, (732) 7272229, Victoria.larkin@rwjbh.org
- Recruiting
Robert Wood Johnson University Hospital Somerset Cardiac Rehabilitation Program
Hillsborough, New Jersey, 08844
Theresa Venditti, 9086852453, theresa.venditti@RWJBH.org
- Recruiting
Rutgers Emotion, Health and Behavior Laboratory Department of Psychology
New Brunswick, New Jersey, 08901
Samantha Farris, PhD, (845) 445-2174, samantha.farris@rutgers.edu
About this study
Official title: A Tailored Exposure Intervention for Exercise Anxiety and Avoidance in Cardiac Rehabilitation
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.
Read the detailed description
This study is a Stage II randomized-controlled trial of a novel behavioral intervention, titled Behavioral Exposure for Interoceptive Tolerance (BE-FIT), to evaluate (1) its efficacy in improving exercise adherence in CR and (2) its mechanisms of change in individuals 40 years of age and older. One hundred and forty-six patients enrolled in Robert Wood Johnson University Hospital (RWJ) cardiac rehabilitation (CR) program who have elevated exercise anxiety, as indicated by endorsement of much to very much concern about at least 3 items on the Exercise Sensitivity Questionnaire (ESQ; Farris et al., 2020) and meet other eligibility criteria will be randomly assigned to either receive BE-FIT, a tailored intervention specifically for CR patients with high levels of exercise anxiety (n=73), or the health education condition (HEC; n=73), which are matched for contact time. Eligible participants will be stratified based on their risk profile (determined by their electronic health record), age, sex, and ESQ score. These stratification variables were selected because they are associated with anxiety and fitness levels which could impact physical activity (PA) outcomes. Both conditions will be administered by trained doctoral-level students enrolled at Rutgers University and will be supervised throughout the course of the study by Dr. Farris and other listed co-investigators.
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. The alternative type of intervention is the Health Education Control (HEC), which is a time-matched control intervention that will be delivered on the same delivery schedule as BE-FIT. The doctoral-level clinicians who will be delivering HEC will be exclusively trained in order to avoid contamination with the BE-FIT intervention. In this control 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. The HEC protocol has been used in prior studies conducted by Dr. Abrantes (co-investigator).
The overall duration of the study is 24 weeks, or approximately 6 months. Subjects will be involved in 6 individual sessions delivered twice weekly during the initial weeks of outpatient CR. Sessions occur for 45 minutes either immediately before or after regularly scheduled CR sessions. Five independent assessments are conducted at baseline, EOT, and three follow-ups (Weeks 12, 18, 24). Data collection will occur at each visit, with baseline data collected at the initial visit.
- Being tested
- Behavioral Exposure For Introceptive Tolerance, Health Education Control
- Keywords
- Exercise Sensitivity, Introceptive Exposure, Kinesiophobia, Acceptance and Commitment Therapy
- Medical subject headings
- Anxiety Disorders, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Exposure For Introceptive ToleranceBehavioural
Also called BEFIT
BE-FIT will consist of a 6-session one-on one program with a clinician that are approximately 45 minutes delivered, over the course of 3 weeks (twice/week). Sessions will coincide with scheduled cardiac rehabilitation sessions at RWJ Cardiac Rehabilitation Program. The elements of BE-FIT are (1) psychoeducation about avoidance/anxiety and values clarification and committed action for exercise and lifestyle PA; (2) graded, repeated exposure to bodily sensations and exercise to build tolerance of discomfort; (3) fading safety behaviors and elimination of exercise avoidance behaviors to promote tolerance of uncertainty and reduce catastrophizing; and (4) use of Fitbit activity tracker to facilitate physical activity monitoring and provide physical activity feedback and goal-setting.
Health Education ControlBehavioural
Also called HEC
HEC is a time-matched control intervention that will be administered on the same delivery schedule as BE-FIT. The intervention content includes: (1) educational information about health topics relevant to healthy aging, and (2) Use of the Fitbit activity watch for PA monitoring. The 6 topics introduced in the HEC include: nutrition, sleep, brain health, emotional health, living with chronic conditions, how to be a smart patient. The health information will be conveyed through lectures and handouts. The goal of sessions will be to provide education, particularly as it relates to healthy aging. Patients will be given the same Fitbit as in the BE-FIT but will not be given PA goals.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Exposure For Introceptive Tolerance | Experimental | 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. Receives: Behavioral: Behavioral Exposure For Introceptive Tolerance |
| Health Education Control | Active comparator | 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. Receives: Behavioral: Health Education Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall minutes of exercise
Objectively measured exercise (moderate-to-vigorous intensity physical activity mins/day) on both CR and non-CR days.
Measured: 24 weeks
Secondary outcomes (2)
Percent of prescribed cardiac rehabilitation attended.
Measured: 24 weeks
Objectively measured Lifestyle PA (steps/day).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start3 May 2022
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exercise SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Samantha Farris, Ph.D., Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398276
- Sponsor's protocol ID
- 2021000886
- Other IDs
- R01AG070136
- Acronym
- BE-FIT
- Status last verified
- Jun 2026
- First submitted
- 26 May 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farris SG, Kibbey MM, Derby L, Keller B, Leyro TM, Alderman BL, Steinberg MB, Abrantes AM, DiBello AM. A Confirmatory Factory Analysis of the Exercise Sensitivity Questionnaire (ESQ). J Cardiopulm Rehabil Prev. 2025 May 1;45(3):207-214. doi: 10.1097/HCR.0000000000000933. Epub 2025 Feb 28.
PubMed 40014001Farris SG, Kibbey MM, Keller B, Derby L, Leyro TM, Alderman BL, DiBello AM, Steinberg MB, Abrantes AM. Behavioral Exposure for Interoceptive Tolerance (BE-FIT): A stage II randomized clinical trial protocol. Contemp Clin Trials. 2024 Dec;147:107706. doi: 10.1016/j.cct.2024.107706. Epub 2024 Oct 9.
PubMed 39389421
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tailored Exposure Intervention for Exercise Anxiety and Avoidance in Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT05398276
- Acronym / sponsor ID
- BE-FIT / 2021000886
- Keywords
- Exercise Sensitivity, Introceptive Exposure, Kinesiophobia, Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 3 May 2022 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a Stage II randomized-controlled trial of a novel behavioral intervention, titled Behavioral Exposure for Interoceptive Tolerance (BE-FIT), to evaluate (1) its efficacy in improving exercise adherence in CR and (2) its mechanisms of change in individuals 40 years of age and older. One hundred and forty-six patients enrolled in Robert Wood Johnson University Hospital (RWJ) cardiac rehabilitation (CR) program who have elevated exercise anxiety, as indicated by endorsement of much to very much concern about at least 3 items on the Exercise Sensitivity Questionnaire (ESQ; Farris et al., 2020) and meet other eligibility criteria will be randomly assigned to either receive BE-FIT, a tailored intervention specifically for CR patients with high levels of exercise anxiety (n=73), or the health education condition (HEC; n=73), which are matched for contact time. Eligible participants will be stratified based on their risk profile (determined by their electronic health record), age, sex, and ESQ score. These stratification variables were selected because they are associated with anxiety and fitness levels which could impact physical activity (PA) outcomes. Both conditions will be administered by trained doctoral-level students enrolled at Rutgers University and will be supervised throughout the course of the study by Dr. Farris and other listed co-investigators.
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. The alternative type of intervention is the Health Education Control (HEC), which is a time-matched control intervention that will be delivered on the same delivery schedule as BE-FIT. The doctoral-level clinicians who will be delivering HEC will be exclusively trained in order to avoid contamination with the BE-FIT intervention. In this control 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. The HEC protocol has been used in prior studies conducted by Dr. Abrantes (co-investigator).
The overall duration of the study is 24 weeks, or approximately 6 months. Subjects will be involved in 6 individual sessions delivered twice weekly during the initial weeks of outpatient CR. Sessions occur for 45 minutes either immediately before or after regularly scheduled CR sessions. Five independent assessments are conducted at baseline, EOT, and three follow-ups (Weeks 12, 18, 24). Data collection will occur at each visit, with baseline data collected at the initial visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Exposure For Introceptive Tolerance | Experimental | Behavioral: Behavioral Exposure For Introceptive ToleranceThe 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. |
| Health Education Control | Active comparator | Behavioral: Health Education ControlHEC 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 40 years of age
- Elevated exercise anxiety (score of ≥ 30 on ESQ-18)
- Low active (< 90 min self-reported moderate-to-vigorous intensity physical activity/day in past three months)
- Medically approved cardiac rehabilitation
- English proficiency
Key exclusion criteria (3 listed)
- Evidence of cognitive impairment (≤ 23 on Montreal Cognitive Assessment; MoCA)
- Severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevents safe or adequate participation
- Expectation that patient will not live through study periods
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Exposure For Introceptive ToleranceAlso: BEFITBE-FIT will consist of a 6-session one-on one program with a clinician that are approximately 45 minutes delivered, over the course of 3 weeks (twice/week). Sessions will coincide with scheduled cardiac rehabilitation sessions at RWJ Cardiac Rehabilitation Program. The elements of BE-FIT are (1) psychoeducation about avoidance/anxiety and values clarification and committed action for exercise and lifestyle PA; (2) graded, repeated exposure to bodily sensations and exercise to build tolerance of discomfort; (3) fading safety behaviors and elimination of exercise avoidance behaviors to promote tolerance of uncertainty and reduce catastrophizing; and (4) use of Fitbit activity tracker to facilitate physical activity monitoring and provide physical activity feedback and goal-setting. | Behavioural | Behavioral Exposure For Introceptive Tolerance |
| Health Education ControlAlso: HECHEC is a time-matched control intervention that will be administered on the same delivery schedule as BE-FIT. The intervention content includes: (1) educational information about health topics relevant to healthy aging, and (2) Use of the Fitbit activity watch for PA monitoring. The 6 topics introduced in the HEC include: nutrition, sleep, brain health, emotional health, living with chronic conditions, how to be a smart patient. The health information will be conveyed through lectures and handouts. The goal of sessions will be to provide education, particularly as it relates to healthy aging. Patients will be given the same Fitbit as in the BE-FIT but will not be given PA goals. | Behavioural | Health Education Control |
Primary outcome
Overall minutes of exercise
Time frame: 24 weeks
Objectively measured exercise (moderate-to-vigorous intensity physical activity mins/day) on both CR and non-CR days.
2 secondary outcomes
Percent of prescribed cardiac rehabilitation attended.
Time frame: 24 weeks
Objectively measured Lifestyle PA (steps/day).
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Derived from this study: PubMed 40014001Farris SG, Kibbey MM, Derby L, Keller B, Leyro TM, Alderman BL, Steinberg MB, Abrantes AM, DiBello AM. A Confirmatory Factory Analysis of the Exercise Sensitivity Questionnaire (ESQ). J Cardiopulm Rehabil Prev. 2025 May 1;45(3):207-214. doi: 10.1097/HCR.0000000000000933. Epub 2025 Feb 28.
- Derived from this study: PubMed 39389421Farris SG, Kibbey MM, Keller B, Derby L, Leyro TM, Alderman BL, DiBello AM, Steinberg MB, Abrantes AM. Behavioral Exposure for Interoceptive Tolerance (BE-FIT): A stage II randomized clinical trial protocol. Contemp Clin Trials. 2024 Dec;147:107706. doi: 10.1016/j.cct.2024.107706. Epub 2024 Oct 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Exposure For Introceptive Tolerance in people with Exercise Sensitivity and Introceptive Exposure, run by Rutgers, The State University of New Jersey at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha G Farris, PhD ((845) 445-2174, samantha.farris@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall minutes of exercise (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05398276, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.