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: 6

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different forms of exercise, such as muscular fitness and strength training, affect blood vessel function in individuals with mental health conditions like PTSD (posttraumatic stress disorder) and generalized anxiety disorder (GAD). Participants will join either a muscular fitness or muscular strength group for 10 weeks of resistance training. Suitable candidates for this study include individuals who feel generally healthy but experience PTSD or anxiety impacting their daily lives. As an unphased trial, this study provides a unique opportunity to contribute to understanding the benefits of exercise on mental health and cardiovascular function.

Will I have to stop taking my current medications?

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

What prior data suggests that these exercise training methods are safe for individuals with mental health disorders?

Studies have shown that building muscle fitness and strength can benefit mental health. Physical activity, for instance, can reduce symptoms of depression and anxiety. Resistance training, which strengthens muscles, is particularly effective for mental health, especially in older adults.

Research has also shown that these exercises are generally safe. Resistance training can improve heart health, even for those with heart conditions, making it accessible for most people. The positive effects on mental health suggest it can also enhance overall well-being. The exercises in this study are not new treatments but are based on well-known exercises that are usually safe and beneficial for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore the potential of exercise training to improve mental health. Unlike typical treatments for mental illness, such as medication and therapy, these methods focus on physical activity to enhance well-being. The Muscular Fitness Training Group aims to boost overall fitness, while the Muscular Strength Training Group focuses on increasing strength, potentially offering different mental health benefits. This approach could provide a new, non-pharmaceutical option for individuals seeking to manage mental health conditions, highlighting the interconnectedness of physical and mental health.

What evidence suggests that this trial's treatments could be effective for mental health disorders?

Research has shown that exercises to build muscle strength and fitness can improve mental health. In this trial, participants will join either the Muscular Fitness Training Group or the Muscular Strength Training Group. Studies have found that resistance training, such as lifting weights, can reduce symptoms of depression and anxiety. Specifically, exercises that enhance muscle fitness are linked to fewer depression symptoms and better overall mental health. Similarly, strength training can significantly boost mental health in just 12 weeks. This type of exercise also benefits physical health by increasing muscle and reducing body fat, which may help improve mental well-being. Overall, exercise, including resistance training, positively affects mental health. ^{1 2 6 7 8}

Who Is on the Research Team?

Ryan Garten, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for healthy individuals and those with PTSD or GAD who have specific scores on mental health scales. It's not for pregnant women, current/recent smokers, people with limited English proficiency, those on certain cardiovascular meds, drug/alcohol users, or anyone on a significant calorie restriction.

Inclusion Criteria

For the GAD group, your score on the GAD-7 self-report scale should be 10 or higher, and your score on the PCL-5 checklist should be less than 33.

Healthy participants should have low scores on the GAD-7 and PCL-5 questionnaires.

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

Exclusion Criteria

Limited English proficiency

You are using illegal drugs or drinking too much alcohol.

I have recently quit smoking.

Timeline for a Trial Participant

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 require one blood draw

1 day

1 visit (in-person)

Testing Sessions

Participants undergo multiple tests to determine blood vessel health, including antioxidant or placebo administration

2 days

2 visits (in-person)

Exercise Training

Participants engage in 10 weeks of resistance training for muscular fitness or strength

10 weeks

3-5 days per week

Follow-up

Participants are monitored for changes in vascular function from baseline to the end of the final visit

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Muscular Fitness Training Group
• Muscular Strength Training Group

Trial Overview

The study is testing the effects of two types of exercise training—muscular fitness and strength training—on blood vessel function in both healthy participants and those with PTSD or GAD.

How Is the Trial Designed?

Group I: Muscular fitness Experimental Treatment 1 Intervention

Participants will complete study 1 (HM20020955-1) and then 10 weeks of resistance training for muscular fitness

Group II: Muscular Strength Experimental Treatment 1 Intervention

Participants will complete study 1 (HM20020955-1) and then 10 weeks of resistance training for muscular strength

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Published Research Related to This Trial

A study involving 67 participants showed that online home-based resistance training significantly improved depressive symptoms, as measured by the CES-D scale, after eight weeks of training.

The training also enhanced fitness parameters, indicating that low-load resistance exercises can be an effective way to improve mental health and physical fitness, even when conducted online.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Online Home-Based Resistance Exercise Training on Physical Fitness, Depression, Stress, and Well-Being in Middle-Aged Persons: A Pilot Study. Kikuchi, N., Ohta, T., Hashimoto, Y., et al.[2023]

Patients with schizophrenia have a significantly higher prevalence of metabolic syndrome and cardiovascular diseases, leading to a reduced life expectancy of up to 20 years compared to the general population.

Regular physical activity, particularly high-intensity interval training, can improve metabolic syndrome parameters, cognitive deficits, and overall quality of life in schizophrenia patients, although more controlled trials are needed to establish effective exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Aerobic Exercise on Metabolic Syndrome, Cardiorespiratory Fitness, and Symptoms in Schizophrenia Include Decreased Mortality. Schmitt, A., Maurus, I., Rossner, MJ., et al.[2020]

Regular resistance training is highly effective for increasing lean body mass and improving muscular strength and endurance, making it a key component of health maintenance for individuals of all ages.

Tailored resistance-exercise programs, involving at least 1 set of 8 to 10 exercises targeting major muscle groups performed 2 to 3 times a week, can safely provide significant health benefits and help prevent chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription of resistance training for healthy populations. Hass, CJ., Feigenbaum, MS., Franklin, BA.[2018]

In a 15-year inpatient treatment program for depression, patients who participated in physical fitness training three times a week for six to nine weeks showed significant improvements in fitness levels and reductions in depression scores.

More than half of the patients continued to exercise regularly one year after discharge, and they ranked physical fitness training as one of the most valuable components of their treatment, indicating its long-term benefits and safety with no serious complications reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical training as a therapeutic method in depression]. Martinsen, EW.[2008]

Aerobic exercise training significantly reduces negative symptoms of schizophrenia, as indicated by improvements in the Positive and Negative Syndrome Scale (PANSS) scores, while resistance training did not show significant effects on these symptoms.

Overall, participation in any form of exercise (aerobic, resistance, or combined) leads to improvements in health-related physical fitness indicators, including body mass index and oxygen consumption, highlighting the benefits of exercise for individuals living with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Aerobic, Resistance, and Combined Exercise Training on Psychiatric Symptom Severity and Related Health Measures in Adults Living With Schizophrenia: A Systematic Review and Meta-Analysis. Bredin, SSD., Kaufman, KL., Chow, MI., et al.[2022]

A 24-week aerobic exercise program for adults with severe chronic schizophrenia was found to be feasible and safe, with participants attending an average of 73% of sessions and experiencing no adverse events.

The program led to a significant reduction in body weight (2.4%) and body mass index (2.2%), indicating potential benefits for physical health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A small group aerobic exercise programme that reduces body weight is feasible in adults with severe chronic schizophrenia: a pilot study. Dodd, KJ., Duffy, S., Stewart, JA., et al.[2011]

A 12-week moderate-intensity bench-step exercise training program significantly improved cardiopulmonary fitness, as evidenced by increased performance in the 6-minute walk test among patients with schizophrenia.

The exercise program also led to a notable reduction in depressive symptoms, as measured by the Beck Depression Inventory-II, indicating potential benefits for mood state, although it did not affect attention as measured by the Symbol Digit Modalities Test.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-Weeks of Bench-Step Exercise Training Ameliorates Cardiopulmonary Fitness and Mood State in Patients with Schizophrenia: A Pilot Study. Kuo, YC., Chang, DY., Liao, YH.[2021]

A 12-week program of maximal strength training significantly improved lower extremity force-generating capacity in patients with schizophrenia, bringing their performance levels in leg press strength and rapid force development in line with healthy individuals.

The training also enhanced functional performance, as evidenced by improvements in the 30-second sit-to-stand test, indicating that strength training can positively impact both physical capabilities and quality of life for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strength training restores force-generating capacity in patients with schizophrenia. Nygård, M., Brobakken, MF., Taylor, JL., et al.[2021]

A six-week exercise program for hospitalized psychiatric patients led to significant reductions in reported depression levels, highlighting the efficacy of exercise as a therapeutic intervention in this setting.

While the program did not significantly reduce feelings of anger or fear, it still showed enough potential benefits to recommend its inclusion in regular psychiatric inpatient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of exercise on a psychiatric hospital unit. Conroy, RW., Smith, K., Felthous, AR.[2019]

Physical exercise has been shown to significantly benefit individuals with severe mental illnesses like schizophrenia by improving cognitive functions, global functioning, and alleviating negative symptoms, while also promoting neurogenesis and angiogenesis.

Successful engagement in physical activity programs for those with mental illnesses is enhanced when the programs are enjoyable, promote personal choice, and provide social support, highlighting the need for better integration of mental health services with community exercise resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Schizophrenia spectrum disorders and physical exercise]. Makris, K., Kollias, K.[2021]

A physical fitness training program for inpatients with psychiatric disorders, consisting of group exercise sessions three times a week for six weeks, can improve self-esteem and body image among these patients.

The study highlights the need for physical therapy practices to expand their focus to include the unique needs of individuals with mental health issues, recognizing the close relationship between physical and psychological health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical fitness program for patients with psychiatric disorders. A clinical report. Chastain, PB., Shapiro, GE.[2019]

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