Behavioral Exposure Therapy for Exercise Intolerance

(BE-FIT Trial)

Recruiting at 1 trial location

Overseen By Samantha G Farris, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Cognitive impairment, Severe chronic conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 6 weeks

146 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Behavioral Exposure Therapy for Exercise Intolerance?

Research on similar treatments, like graded exposure therapy for chronic low back pain, shows that gradually facing feared activities can reduce fear and improve activity levels. Additionally, virtual reality exposure therapy has shown promise in reducing pain-related fears in fibromyalgia patients, suggesting that exposure-based approaches can help manage exercise intolerance by addressing fear and anxiety related to movement. ^{1 2 3 4 5}

Is Behavioral Exposure Therapy for Exercise Intolerance safe for humans?

In a pilot study of BE-FIT, a type of Behavioral Exposure Therapy, no adverse events were reported, indicating it is generally safe for humans. ^{6 7 8 9 10}

How is the BE-FIT treatment different from other treatments for exercise intolerance?

BE-FIT is unique because it combines exposure to feared physical sensations with acceptance and values-focused processes, specifically targeting exercise sensitivity in people with cardiovascular issues. This approach is different from traditional treatments as it directly addresses the fear of physical exertion by gradually exposing patients to these sensations in a controlled and supportive environment. ^{6 7 8 9 11}

Eligibility Criteria

This trial is for individuals over 40 with high exercise anxiety, approved for cardiac rehab, and not very active. They must speak English and have no severe cognitive impairments or chronic conditions that could interfere with the study.

Inclusion Criteria

I am enrolled in a heart health rehab program.

You haven't been very active, doing less than 90 minutes of moderate-to-vigorous exercise each day in the past three months.

You experience high levels of anxiety when it comes to exercise (scoring 30 or higher on a specific questionnaire).

Exclusion Criteria

It is expected that the patient will not survive during the study.

You have problems with your memory and thinking abilities, as shown by a test called the Montreal Cognitive Assessment (MoCA) where you scored 23 or lower.

Severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevents safe or adequate participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BE-FIT intervention or Health Education Control over 6 individual sessions delivered twice weekly during the initial weeks of outpatient cardiac rehabilitation

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for exercise adherence and anxiety reduction with assessments at baseline, end of treatment, and three follow-up points

18 weeks

3 visits (in-person)

Treatment Details

Interventions

• Behavioral Exposure For Introceptive Tolerance
• Health Education Control

Trial Overview The BE-FIT program aims to reduce exercise anxiety through exposure therapy, stopping safety behaviors around exercise, and using a wrist activity monitor. It's being compared to standard health education in a randomized-controlled trial.

Participant Groups

Group I: Behavioral Exposure For Introceptive Tolerance Experimental Treatment 1 Intervention

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.

Group II: Health Education Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

The study developed graded exposure (GEXP) virtual reality (VR) modules for individuals with chronic low back pain (cLBP) and high pain-related fear, showing that participants could safely engage in progressively challenging physical activities over three sessions.

Participants found the VR application to be feasible and acceptable, with no significant changes in pain or pain-related fear, indicating that they could complete the modules without exacerbating their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Graded Exposure, Locomotion-Enabled Virtual Reality App During Walking and Reaching for Individuals With Chronic Low Back Pain: Cohort Gaming Design. Hennessy, RW., Rumble, D., Christian, M., et al.[2020]

This scoping review analyzed 196 studies to explore how quantitative sensory testing can measure sensory changes related to physical activity in adults, highlighting its potential as a tool for assessing exercise-induced hypoalgesia.

The majority of studies focused on healthy adults and those with chronic conditions, primarily using pressure pain threshold measurements, indicating that physical activity can lead to significant neuromodulation effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative Sensory Changes Related to Physical Activity in Adult Populations: A Scoping Review. Baehr, LA., Frey-Law, LA., Finley, M.[2023]

A novel virtual reality exposure therapy program was tested on 13 patients with fibromyalgia syndrome, showing potential to alter pain catastrophizing related to exercise, which is crucial for improving exercise compliance.

Functional MRI results indicated that exercise visuals activated specific brain areas associated with pain processing in fibromyalgia patients, suggesting that this therapy could lead to neurophysiological changes that help manage pain perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting pain catastrophization in patients with fibromyalgia using virtual reality exposure therapy: a proof-of-concept study. Morris, LD., Louw, QA., Grimmer, KA., et al.[2020]

In a study involving 8 fibromyalgia patients, Cognitive Behavioral Treatment (CBT) showed improvements in pain catastrophizing, particularly with the imagined exposure technique, although no significant changes were observed in pain intensity or overall fibromyalgia impact.

The results indicate that while CBT can help reduce negative thought patterns related to pain, further research with larger groups is necessary to validate these findings and explore the effectiveness of imagined exposure in enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Imagined exposure as treatment of catastrophizing in fibromyalgia: a pilot study]. Rodero, B., García, J., Casanueva, B., et al.[2018]

A study involving four chronic low back pain patients with significant fear of movement showed that graded exposure in vivo treatment was effective in reducing pain-related fears, catastrophizing, and pain disability, while usual graded activity did not lead to improvements.

Improvements in pain-related fear were associated with decreases in pain catastrophizing and disability, indicating that graded exposure can enhance pain control in patients with high fear of movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graded exposure in vivo in the treatment of pain-related fear: a replicated single-case experimental design in four patients with chronic low back pain. Vlaeyen, JW., de Jong, J., Geilen, M., et al.[2022]

The BE-FIT intervention, a 6-session program designed to help patients with cardiovascular disease manage exercise sensitivity, was found to be safe and highly acceptable, with participants completing all sessions and reporting no adverse events.

Patients who underwent BE-FIT showed significant improvements in exercise sensitivity and increased physical activity levels, while the control group only experienced minimal changes, highlighting BE-FIT's potential efficacy in promoting physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Be brave, BE-FIT! A pilot investigation of an ACT-informed exposure intervention to reduce exercise fear-avoidance in older adults. Farris, SG., Kibbey, MM.[2023]

A 15-week high-intensity aerobic exercise program significantly increased smoking abstinence rates among 150 adult smokers with high anxiety sensitivity, achieving a 27.6% abstinence rate compared to 14.8% in the control group.

Despite both groups showing a decline in anxiety sensitivity, the exercise program's effectiveness in promoting smoking cessation did not appear to be linked to changes in anxiety sensitivity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based smoking cessation treatment for adults with high anxiety sensitivity: a randomized clinical trial. Smits, JAJ., Zvolensky, MJ., Rosenfield, D., et al.[2023]

The study identified four key types of interoceptive fears related to panic disorder: pseudoneurological, gastrointestinal, cardiorespiratory, and dissociative feelings, using the Body Sensations Questionnaire (BSQ) with a focus on interoceptive exposure exercises.

Specific interoceptive exposure tasks, such as hyperventilation and holding breath, were effective in significantly reducing pseudoneurological fears, indicating their potential utility in cognitive behavioral therapy for panic disorder, while highlighting the need for new tasks targeting cardiorespiratory and dissociative symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interoceptive hypersensitivity and interoceptive exposure in patients with panic disorder: specificity and effectiveness. Lee, K., Noda, Y., Nakano, Y., et al.[2023]

A brief group cognitive behavioral therapy combined with running as an interoceptive exposure was effective in reducing anxiety sensitivity levels in female undergraduates, particularly in those with high anxiety sensitivity.

The study found that decreases in cognitive and emotional reactions to running, rather than the physical sensations themselves, were linked to reduced anxiety sensitivity, indicating that changing how individuals think and feel about their sensations is key to the therapy's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Running as Interoceptive Exposure for Decreasing Anxiety Sensitivity: Replication and Extension. Sabourin, BC., Stewart, SH., Watt, MC., et al.[2018]

A 10-week mindfulness and acceptance-based intervention, using Acceptance and Commitment Therapy (ACT), showed high adherence rates (89.3% for walking and 85.5% for group sessions) among 24 sedentary adults, indicating its feasibility and acceptability.

Participants experienced significant improvements in cardiorespiratory fitness, evidenced by a large decrease in 1-mile walk test times and a moderate increase in estimated VO2max, alongside a substantial increase in exercise-related acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot testing of a mindfulness- and acceptance-based intervention for increasing cardiorespiratory fitness in sedentary adults: A feasibility study. Martin, EC., Galloway-Williams, N., Cox, MG., et al.[2020]

In a study of 77 patients with panic disorder and agoraphobia, adding moderate-intensity aerobic exercise before exposure-based cognitive behavioral therapy (eb-CBT) showed a trend towards greater symptom improvement compared to low-intensity exercise, particularly in anxiety levels as measured by the Hamilton Anxiety Rating Scale.

All patients experienced significant symptom relief after the treatment period, but the benefits of moderate-intensity exercise diminished at follow-up, suggesting that while it may accelerate initial improvements, lower-intensity exercise could lead to continued benefits over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Running for extinction? Aerobic exercise as an augmentation of exposure therapy in panic disorder with agoraphobia. Bischoff, S., Wieder, G., Einsle, F., et al.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

A Graded Exposure, Locomotion-Enabled Virtual Reality App During Walking and Reaching for Individuals With Chronic Low Back Pain: Cohort Gaming Design. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Quantitative Sensory Changes Related to Physical Activity in Adult Populations: A Scoping Review. [2023]

3. Japan pubmed.ncbi.nlm.nih.gov

Targeting pain catastrophization in patients with fibromyalgia using virtual reality exposure therapy: a proof-of-concept study. [2020]

4. Spain pubmed.ncbi.nlm.nih.gov

[Imagined exposure as treatment of catastrophizing in fibromyalgia: a pilot study]. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Graded exposure in vivo in the treatment of pain-related fear: a replicated single-case experimental design in four patients with chronic low back pain. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Be brave, BE-FIT! A pilot investigation of an ACT-informed exposure intervention to reduce exercise fear-avoidance in older adults. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Community-based smoking cessation treatment for adults with high anxiety sensitivity: a randomized clinical trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Interoceptive hypersensitivity and interoceptive exposure in patients with panic disorder: specificity and effectiveness. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Running as Interoceptive Exposure for Decreasing Anxiety Sensitivity: Replication and Extension. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Pilot testing of a mindfulness- and acceptance-based intervention for increasing cardiorespiratory fitness in sedentary adults: A feasibility study. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Running for extinction? Aerobic exercise as an augmentation of exposure therapy in panic disorder with agoraphobia. [2022]