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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different exercise levels can reduce anxiety in people who don't usually exercise. Participants will either engage in low-intensity exercise or gradually progress to high-intensity exercise over eight weeks. Researchers will use heart rate and other tools to assess changes in anxiety and factors influencing adherence. It suits adults with a primary anxiety disorder who are sensitive to anxiety and currently not very active. As an unphased trial, this study offers a unique opportunity to explore how exercise can personally benefit mental health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that high-intensity exercise is generally safe and can improve mental health. A review of several studies found that high-intensity interval training (HIIT) can reduce anxiety symptoms, particularly in individuals with higher anxiety levels. These studies also suggest that HIIT can enhance heart health and overall quality of life without major safety concerns.

However, about 23% of participants discontinue HIIT, indicating that some may find it challenging to maintain this type of exercise. No major health problems were reported in these studies, underscoring its safety.

In summary, both low and high-intensity exercises are safe, with high-intensity exercise offering specific benefits for those with anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using exercise to manage anxiety because it offers a natural, non-drug option that could complement or even reduce the need for medications like SSRIs or benzodiazepines, which often come with side effects. This trial explores how different intensities of exercise might have varying impacts on anxiety levels, offering a personalized approach that could lead to more effective treatments. High-intensity exercise may trigger endorphin release and increase neuroplasticity, potentially providing faster relief for anxiety symptoms compared to traditional treatments. Moreover, exercise is accessible and has additional health benefits, making it a holistic option for managing anxiety.

What evidence suggests that this trial's exercise treatments could be effective for anxiety?

This trial will compare the effects of different exercise intensities on anxiety. Participants will join either a high-intensity or low-intensity exercise group. Studies have shown that intense exercise effectively reduces anxiety symptoms. Specifically, research found that high-intensity interval training (HIIT) can significantly improve anxiety and help with accompanying depression. Another study showed that more intense workouts lead to better improvements in both anxiety and depression compared to less intense exercises. Meanwhile, earlier research suggests that any exercise, even if not intense, can help lower anxiety sensitivity. These findings support the idea that various exercise levels can aid in managing anxiety. ^{1 2 6 7 8}

Who Is on the Research Team?

Kristin Szuhany, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11880788/

The impact of high-intensity interval training on anxiety Twelve studies indicated that HIIT significantly improves anxiety symptoms, especially for individuals with lower baseline anxiety.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3632802/

Effects of Exercise and Physical Activity on Anxiety - PMC A number of research studies have pointed to the effectiveness of short-term aerobic exercise to reduce anxiety sensitivity (Broman-Fulks and Storey, 2008; ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1755296624000486

Can high-intensity interval training improve health ... HIIT may improve cardiorespiratory fitness and reduce drug craving among individuals with SUDs, potentially improving treatment outcomes and lowering the risk ...

4. bjsm.bmj.com bjsm.bmj.com/content/57/18/1203

Effectiveness of physical activity interventions for improving ... All PA modes were effective, and higher intensity exercise was associated with greater improvements for depression and anxiety. Longer duration interventions ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0887618520301250

A randomized controlled trial of high intensity interval ... This RCT investigated high intensity interval training (HIIT) in GAD. HIIT was highly effective in reducing symptom severity and comorbid depression.

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/sms.14618

Effects of high‐intensity interval training on depressive and ... HIIT does not improve symptoms of depression and anxiety in healthy individuals. This finding is based on evidence of very low certainty.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12027975/

Narrative Review of High-Intensity Interval Training: Positive ... This review highlights HIIT as an effective and safe exercise modality for improving CV health, metabolic indicators, mental health, and QoL.

8. who.int who.int/news-room/fact-sheets/detail/physical-activity

Physical activity Both moderate- and vigorous-intensity physical activity improve health. Popular ways to be active include walking, cycling, wheeling, sports ...