Exercise Training for Mental Illness

Overseen By Ryan Garten, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must not be taking: Cardiovascular medications

Disqualifiers: Smoking, Drug use, Pregnancy, others

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

Compensation: Varies

Number of Visits: 8

360 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to examine the effect of various forms of exercise training on blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).

Will I have to stop taking my current medications?

If you are taking medications that could affect heart and blood vessel function, you may need to stop taking them to participate in this trial.

What data supports the effectiveness of this treatment for mental illness?

Research shows that high-intensity interval training (HIIT) can improve both mental and physical health in people with severe mental illnesses like schizophrenia and depression. HIIT has been found to enhance cardiorespiratory fitness and reduce depressive symptoms, making it a promising treatment option. ^{1 2 3 4 5}

Is exercise training safe for people with mental illness?

High-intensity interval training (HIIT) appears to be as safe as moderate-intensity continuous training (MCT) for people with severe mental illness, with few safety concerns reported in studies. ^{3 4 5 6 7}

How is the exercise training treatment for mental illness different from other treatments?

This treatment uses high-intensity interval training (HIIT), which involves short bursts of intense exercise followed by rest, and is unique because it can improve both mental and physical health in a time-efficient manner, potentially increasing adherence compared to traditional exercise programs. ^{1 2 3 5 8}

Research Team

Ryan Garten, PhD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for healthy individuals and those with PTSD or GAD who want to explore how different exercise routines affect blood vessel function. Participants should not have cardiovascular, pulmonary, or metabolic diseases. They must not be pregnant, on certain medications, recent smokers, drug users, heavy drinkers, or have significant dietary restrictions.

Inclusion Criteria

I am healthy with no major heart, lung, or metabolic diseases.

If you are in the PTSD group, you need to have a score of 33 or higher on the PCL-5 checklist.

For the GAD group, you have to score 10 or higher on the GAD-7 self-report scale and less than 33 on the PCL-5 checklist.

Exclusion Criteria

You use illegal drugs or drink too much alcohol.

You are not on a strict diet or have any vitamin or mineral deficiencies.

Pregnant women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Testing

Participants undergo initial testing to familiarize with study equipment and procedures, determine body measures, maximum strength, and a blood draw

< 1 hour

1 visit (in-person)

Baseline Testing

Participants undergo baseline testing to determine blood vessel health, including antioxidant or placebo administration

2-3 hours per session

2 visits (in-person)

Exercise Training

Participants engage in 10 weeks of exercise training with varying intensity and volume

10 weeks

3-5 sessions per week

Post-Training Testing

Participants undergo post-training testing to assess changes in vascular function

2-3 hours per session

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• High Intensity, Normal Volume Exercise Training
• Moderate Intensity, High Volume Exercise Training
• Moderate Intensity, Normal Volume Exercise Training

Trial Overview The study tests three types of exercise training: high intensity normal volume; moderate intensity normal volume; and moderate intensity high volume. It aims to see which routine best improves vascular function in both healthy people and those with mental health disorders.

Participant Groups

Group I: Moderate Intensity, Normal Volume Exercise Training Experimental Treatment 1 Intervention

Participants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, normal volume exercise training

Group II: Moderate Intensity, High Volume Exercise Training Experimental Treatment 1 Intervention

Participants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, high volume exercise training

Group III: High Intensity, Normal Volume Exercise Training Experimental Treatment 1 Intervention

Participants will complete study 1 (HM20020955-1) and then 10 weeks of high intensity, normal volume exercise training

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Findings from Research

High-intensity interval training (HIIT) may help improve depressive symptoms in adults with mental disorders, as indicated by significant improvements in three out of four studies involving 108 participants over 12 days to 8 weeks.

However, HIIT did not show superior effectiveness compared to other forms of low-to-moderate continuous exercise in two-thirds of the studies, suggesting that while it can be beneficial, it may not be the best option for everyone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Rapid Review of Randomized Trials Assessing the Effects of High-Intensity Interval Training on Depressive Symptoms in People with Mental Illness. Ribeiro, JA., Schuch, FB., Vargas, KFM., et al.[2023]

An 8-week high-intensity interval training (HIIT) program significantly improved physical health markers, including reductions in body weight, body mass index, and resting heart rate among 18 patients with chronic schizophrenia.

Mental health also showed improvement, with significant reductions in scores on the Positive and Negative Syndrome Scale, Beck Depression Inventory, and Beck Anxiety Inventory, indicating that HIIT can enhance both physical and mental well-being in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of high-intensity interval training on the mental and physical health of people with chronic schizophrenia. Wu, MH., Lee, CP., Hsu, SC., et al.[2020]

This feasibility study aims to assess the effectiveness of high-intensity interval training (HIIT) in improving physical and mental health among inpatients with severe mental illnesses (SMI), involving 40 patients in a randomized controlled trial over 12 weeks.

If HIIT is found to be feasible and acceptable, it could lead to larger studies evaluating its clinical and cost-effectiveness in inpatient mental health settings, potentially reversing cardiometabolic disease risks associated with SMI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a pilot high-intensity interval training intervention in inpatient mental health settings: a two-part study using a randomised controlled trial and naturalistic study design. Martland, R., Onwumere, J., Stubbs, B., et al.[2021]

High Intensity Interval Training (HIIT) is feasible and safe for individuals with severe mental illness (SMI), showing similar adherence rates to traditional moderate intensity continuous training (MCT).

HIIT resulted in moderate improvements in cardiorespiratory fitness and significantly greater reductions in depression compared to MCT, suggesting it may be a more effective exercise option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Intensity Interval training (HIIT) for people with severe mental illness: A systematic review & meta-analysis of intervention studies- considering diverse approaches for mental and physical recovery. Korman, N., Armour, M., Chapman, J., et al.[2022]

High intensity interval training (HIIT) has been shown to significantly reduce depression severity and improve various physical health metrics, such as cardiorespiratory fitness and HDL levels, in individuals with mental illnesses, based on a systematic review of 12 studies including 7 randomized controlled trials.

The review indicated that HIIT is safe, with no reported acute injuries, and participants showed good adherence to the training sessions, although dropout rates varied widely, highlighting the need for further research to improve retention in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can high intensity interval training improve health outcomes among people with mental illness? A systematic review and preliminary meta-analysis of intervention studies across a range of mental illnesses. Martland, R., Mondelli, V., Gaughran, F., et al.[2023]

A systematic review of 6 studies found no overall difference in time trial (TT) performance improvements between high-intensity interval training (HIIT) and sprint interval training (SIT), indicating both methods are similarly effective for trained individuals.

However, long-duration HIIT (≥ 4 minutes) showed a 2% greater improvement in TT performance compared to SIT, suggesting that longer work intervals may be more beneficial for enhancing performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of High-Intensity Interval Training Versus Sprint Interval Training on Time-Trial Performance: A Systematic Review and Meta-analysis. Rosenblat, MA., Perrotta, AS., Thomas, SG.[2021]

High-intensity interval training (HIIT) significantly reduced depressive symptoms in individuals with schizophrenia compared to low-intensity active video gaming, with a notable effect size that persisted even after a 4-month follow-up.

The reduction in depressive symptoms was associated with improvements in cardiorespiratory fitness (VO2max), suggesting that HIIT may have a beneficial impact on mental health through enhanced physical fitness, although the exact mechanisms require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training may reduce depressive symptoms in individuals with schizophrenia, putatively through improved VO2max: A randomized controlled trial. Bang-Kittilsen, G., Engh, JA., Holst, R., et al.[2022]

High-intensity aerobic training (HIT) significantly improved positive affect and well-being in patients with depression and schizophrenia, with patients maintaining these benefits longer than healthy individuals.

Both patient groups experienced reductions in distress and state anxiety shortly after HIT, with patients with depression showing a greater improvement in distress compared to healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High aerobic intensity training and psychological States in patients with depression or schizophrenia. Heggelund, J., Kleppe, KD., Morken, G., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Rapid Review of Randomized Trials Assessing the Effects of High-Intensity Interval Training on Depressive Symptoms in People with Mental Illness. [2023]

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

Effectiveness of high-intensity interval training on the mental and physical health of people with chronic schizophrenia. [2020]

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

Study protocol for a pilot high-intensity interval training intervention in inpatient mental health settings: a two-part study using a randomised controlled trial and naturalistic study design. [2021]

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

High Intensity Interval training (HIIT) for people with severe mental illness: A systematic review & meta-analysis of intervention studies- considering diverse approaches for mental and physical recovery. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Can high intensity interval training improve health outcomes among people with mental illness? A systematic review and preliminary meta-analysis of intervention studies across a range of mental illnesses. [2023]

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

Effect of High-Intensity Interval Training Versus Sprint Interval Training on Time-Trial Performance: A Systematic Review and Meta-analysis. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

High-intensity interval training may reduce depressive symptoms in individuals with schizophrenia, putatively through improved VO2max: A randomized controlled trial. [2022]

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

High aerobic intensity training and psychological States in patients with depression or schizophrenia. [2023]