Exercise Intensity for Anxiety

Overseen By Giselle Cornejo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Bipolar, Psychotic disorders, Eating disorders, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

90 sedentary adults with a primary anxiety disorder and high anxiety sensitivity will be randomized to either 8 weeks of 1) low intensity exercise, or 2) flexible titration to high intensity exercise (HIE). Blinded, validated clinician-rated and patient-rated outcomes will be assessed over treatment and at 1- and 3-month follow-up. To better understand what mechanisms influence decisions to exercise in the real-world, we will use of heart rate (HR) as an objective mechanistic target for exercise intensity, examine changes in valuation of exercise through a neuroeconomics task, examine changes in interoceptive sensitivity with a heartbeat detection task, and integrate of ecological momentary assessment (EMA) to measure effects of immediate changes in mood with exercise on anxiety outcomes and adherence.

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 Exercise, Physical Activity, Workout, Fitness Training for anxiety?

Research shows that both resistance training and aerobic exercise can significantly reduce anxiety symptoms. A study found that an eight-week resistance exercise program reduced anxiety in young adults, and a meta-analysis confirmed that exercise, especially aerobic, is linked to anxiety reduction. ^{1 2 3 4 5}

Is exercise generally safe for humans?

Exercise, including aerobic and resistance training, is generally safe for humans and can reduce anxiety without the risks associated with drug therapy or psychotherapy. However, some people may experience anxiety in physical activity settings due to factors like social interactions or unfamiliar environments. ^{2 4 6 7 8}

How does exercise as a treatment for anxiety differ from other treatments?

Exercise is unique as a treatment for anxiety because it can reduce anxiety symptoms without the side effects or costs associated with drug therapy or psychotherapy. It works by exposing individuals to physical sensations that can reduce anxiety sensitivity, and both aerobic and resistance exercises have been shown to be effective, with intensity playing a role in the outcome. ^{2 7 9 10 11}

Research Team

Kristin Szuhany, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for sedentary adults aged 18-65 with high anxiety sensitivity and a primary diagnosis of generalized anxiety disorder, social anxiety disorder, or panic disorder. Participants must have a BMI under 40 and exercise less than an hour per week. Those with recent eating disorders, substance abuse, bipolar or psychotic disorders, high suicide risk, or current PTSD cannot join.

Inclusion Criteria

Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)

You have a high level of anxiety sensitivity, as indicated by a score of 23 or higher on the Anxiety Sensitivity Index-3.

Your body mass index (BMI) is less than 40.

Exclusion Criteria

You have had problems with using drugs or alcohol in the past 3 months.

High current suicide risk (active suicidal ideation with plan and intent) as indicated by a score of ≥4 on the Columbia Suicide Severity Rating Scale (C-SSRS) consistent with a need for referral to higher level of care

You have been diagnosed with bipolar disorder or any type of psychotic disorder at any time in your life.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants are randomized to either low intensity exercise or flexible titration to high intensity exercise for 8 weeks

8 weeks

Weekly assessments (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Assessments at 1-month and 3-month follow-up

Treatment Details

Interventions

• Exercise

Trial Overview The study compares the effects of low intensity exercise versus gradually increasing to high intensity exercise on individuals with anxiety disorders over 8 weeks. It includes follow-ups at one and three months post-treatment and uses heart rate monitoring and other tasks to understand how mood changes affect anxiety outcomes.

Participant Groups

Group I: Titration to high intensity exercise Experimental Treatment 1 Intervention

Group II: Low intensity exercise Active Control 1 Intervention

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

An eight-week resistance exercise training (RET) program significantly reduced anxiety symptoms in young adults, with a large effect size (d = 0.85) indicating meaningful improvement compared to a wait-list control group.

The study involved 28 participants and found no significant impact of RET on worry symptoms, suggesting that while RET can help with anxiety, it may not affect worry levels in the same way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance exercise training for anxiety and worry symptoms among young adults: a randomized controlled trial. Gordon, BR., McDowell, CP., Lyons, M., et al.[2021]

Aerobic exercise is associated with significant reductions in both state and trait anxiety, with effects comparable to other anxiety-reducing treatments like relaxation techniques.

To achieve meaningful reductions in anxiety, exercise programs should last at least 10 weeks and include sessions of at least 21 minutes, although the exact minimum duration for effective anxiety reduction is still unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis on the anxiety-reducing effects of acute and chronic exercise. Outcomes and mechanisms. Petruzzello, SJ., Landers, DM., Hatfield, BD., et al.[2022]

A 12-week exercise program improved physical fitness and motor skills in 89 participants, leading to significant reductions in anxiety during stress-inducing tasks compared to a control group.

Exercising subjects experienced lower behavioral, cognitive, and somatic anxiety, and their heart rates recovered faster after stress, indicating that regular exercise can have anxiolytic effects beyond self-reported anxiety levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety and heart rate under psychological stress: The effects of exercise-training. Calvo, MG., Szabo, A., Capafons, J.[2011]

A meta-analysis of 322 participants from 7 studies found that both aerobic exercise and resistance training have significant anxiolytic effects for adults with anxiety and stress-related disorders.

However, the analysis did not find convincing evidence for individualized differences in response to exercise, suggesting that general physical activity guidelines can be effectively applied to this population without needing highly specific recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision-based exercise in people with anxiety and stress related disorders: Are there interindividual differences in anxiolytic effects? An ancillary meta-analysis of randomized controlled trials. Vancampfort, D., Heissel, A., Waclawovsky, A., et al.[2022]

In a study of 376 patients aged 18 to 75 diagnosed with anxiety and/or depression, 58.5% reported engaging in physical exercise, which is comparable to the general population, but suggests that more patients could benefit from exercise as a therapeutic intervention.

Only 59.18% of participants received a prescription for exercise from healthcare providers, indicating a need for improved communication and encouragement from health personnel to promote physical activity as part of treatment for anxiety and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevalence of performing and prescribing physical exercise in patients diagnosed with anxiety and depression]. Iglesias Martínez, B., Olaya Velázquez, I., Gómez Castro, MJ.[2020]

A study involving 122 participants (average age 21.23 years) identified four main sources of anxiety in physical activity settings: fragile self-beliefs, social interaction and fear of negative evaluation, competition, and unfamiliarity with the environment.

Understanding these anxiety-inducing factors can help improve physical activity settings, making them more inclusive and supportive, which may encourage greater participation and reduce anxiety overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Critical Incident Technique to Investigate Anxiety in Physical Activity Settings. Dasinger, TM., Solmon, MA.[2022]

A study involving 15 adults showed that 20-minute cycling sessions at various intensities (40%, 60%, and 70% of VO2peak) significantly reduced state anxiety levels after exercise, with reductions observed at all post-exercise assessments for the lower intensities.

While high-intensity exercise (70% VO2peak) initially increased anxiety levels 5 minutes post-exercise in individuals with low baseline anxiety, it ultimately led to a decrease in anxiety below baseline levels at 60 and 120 minutes, indicating that while high intensity may cause a temporary spike, it is still effective for long-term anxiety reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State anxiety following 20 minutes of bicycle ergometer exercise at selected intensities. Raglin, JS., Wilson, M.[2007]

Acute exercise can lead to a reduction in state anxiety, with 53% of the examined exercise conditions showing significant anxiety reduction in a review of nine studies involving healthy adults.

There is no definitive exercise mode, duration, or intensity that is most effective for reducing anxiety, indicating that a variety of exercise types may be beneficial, but methodological limitations in the studies suggest the need for further research with more targeted participant samples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Acute Exercise on State Anxiety: A Systematic Review. Connor, M., Hargreaves, EA., Scanlon, OK., et al.[2023]

In two experiments involving resistance exercise, it was found that low-intensity exercise (40-50% of 1 RM) significantly decreased anxiety levels for both males and females, while high-intensity exercise (75-85% of 1 RM) increased anxiety for both genders.

The results suggest that exercise intensity plays a crucial role in influencing anxiety, with moderate and high intensities leading to increased anxiety, particularly in males, while low intensity consistently reduces anxiety across genders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State anxiety following resistance exercise: the role of gender and exercise intensity. Bartholomew, JB., Linder, DE.[2019]

In a study with 54 participants, both high-intensity and low-intensity aerobic exercise significantly reduced anxiety sensitivity, which is important for preventing panic attacks.

High-intensity exercise was particularly effective, leading to quicker reductions in anxiety sensitivity and a greater number of treatment responders, while also specifically decreasing fear of anxiety-related bodily sensations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of aerobic exercise on anxiety sensitivity. Broman-Fulks, JJ., Berman, ME., Rabian, BA., et al.[2022]

A systematic review of 12 randomized clinical trials indicates that exercise can reduce anxiety symptoms in adults with high anxiety levels, showing benefits comparable to established treatments and greater than placebo.

Despite these promising findings, the studies had significant methodological limitations, such as small sample sizes and lack of rigorous assessment, which prevent definitive conclusions about the effectiveness of exercise as a treatment for anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as Treatment for Anxiety: Systematic Review and Analysis. Stonerock, GL., Hoffman, BM., Smith, PJ., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Resistance exercise training for anxiety and worry symptoms among young adults: a randomized controlled trial. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

A meta-analysis on the anxiety-reducing effects of acute and chronic exercise. Outcomes and mechanisms. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Anxiety and heart rate under psychological stress: The effects of exercise-training. [2011]

4. Ireland pubmed.ncbi.nlm.nih.gov

Precision-based exercise in people with anxiety and stress related disorders: Are there interindividual differences in anxiolytic effects? An ancillary meta-analysis of randomized controlled trials. [2022]

5. Spain pubmed.ncbi.nlm.nih.gov

[Prevalence of performing and prescribing physical exercise in patients diagnosed with anxiety and depression]. [2020]

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

Using Critical Incident Technique to Investigate Anxiety in Physical Activity Settings. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

State anxiety following 20 minutes of bicycle ergometer exercise at selected intensities. [2007]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Acute Exercise on State Anxiety: A Systematic Review. [2023]

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

State anxiety following resistance exercise: the role of gender and exercise intensity. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Effects of aerobic exercise on anxiety sensitivity. [2022]

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

Exercise as Treatment for Anxiety: Systematic Review and Analysis. [2022]