Exercise Programs for Severe Mental Illness

(ESHANTI Trial)

Overseen By Vishwajit L Nimgaonkar, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Intellectual disability, Angina, Myocardial infarction, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 42

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two programs to determine which better helps individuals with severe mental illness improve daily living skills, such as socializing, working, and managing life. One group will engage in yoga-based exercises, while the other will participate in a Wellness Lifestyle Program, which includes health education and light exercise like walking. Suitable candidates for this trial have conditions such as schizophrenia or bipolar disorder and feel stable in their current treatment. The goal is to identify which program more effectively boosts community functioning and overall well-being. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to enhancing daily living skills.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that there have been no changes in psychoactive medications for the past 4 weeks. This suggests you should be stable on your current medications before joining.

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

Research has shown that yoga exercises are generally safe and well-received in mental health settings. One study found yoga practical and acceptable for people in mental health inpatient settings, with few reports of negative effects, indicating that most participants did not experience major problems. Additionally, a review of 32 studies showed that yoga can help reduce negative symptoms in mental health conditions, suggesting that yoga is not only safe but also potentially beneficial for mental health.

The Wellness Lifestyle Program includes easy exercises like walking and sessions on healthy living. These activities are usually safe and well-tolerated by most people. Overall, both the yoga exercises and the wellness program appear to be safe options for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a holistic approach to managing severe mental illness, which is different from the standard of care primarily focused on medication and psychotherapy. The Yoga-based Exercise (YE) program introduces a series of yoga poses and breathing exercises, promoting physical and mental well-being through gentle movement and mindfulness. Meanwhile, the Wellness Lifestyle Program (WLP) combines educational sessions on healthy living with low-intensity exercises like walking, aiming to empower participants with knowledge and practical skills for better lifestyle choices. These treatments emphasize lifestyle modifications and stress reduction, which are less commonly explored in traditional mental health treatments.

What evidence suggests that this trial's treatments could be effective for Severe Mental Illness?

This trial will compare two exercise programs for individuals with severe mental illness. Research has shown that yoga exercises, which participants in the Yoga-based Exercise (YE) arm will practice, can improve well-being in people with severe mental illness. Studies have found that yoga can reduce depression and anxiety, common in these conditions. People generally enjoy yoga and continue practicing it.

Participants in the Wellness Lifestyle Program (WLP) arm will engage in lessons on healthy living combined with light exercises like walking. This program is considered effective for improving both mental and physical health. Both yoga and the WLP aim to enhance community involvement and improve social and life skills, which are important for people with severe mental illness. ^{3 6 7 8 9}

Who Is on the Research Team?

Vishwajit Laxmikant Nimgaonkar, MD PhD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Are You a Good Fit for This Trial?

This trial is for veterans aged 18-65 with mild to moderately severe schizophrenia, schizoaffective disorder, or bipolar I disorder. Participants should be clinically stable and not have had medication changes in the last month. They must be able to do yoga-based exercises and cannot have severe physical disabilities, uncontrolled blood pressure issues, recent heart problems without doctor's permission, or certain neurological illnesses.

Inclusion Criteria

I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar 1 disorder, and may also have an alcohol or substance use problem.

Written informed consent

My health condition is currently stable.

Exclusion Criteria

I am unable to participate in yoga or similar wellness activities due to physical issues.

I am unable to do yoga or follow a wellness program due to a recent heart issue or uncontrolled blood pressure.

Unable to provide written informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants engage in yoga-based exercises or the Wellness Lifestyle Program twice a week for 12 weeks

12 weeks

24 visits (in-person)

Continued Treatment

Participants engage in yoga-based exercises or the Wellness Lifestyle Program once a week for 12 weeks

12 weeks

12 visits (in-person)

Maintenance Treatment

Participants engage in yoga-based exercises or the Wellness Lifestyle Program once a month for 6 months

6 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Wellness Lifestyle Program
• Yoga-based Exercise

Trial Overview

The study tests if yoga-based exercises can help rehabilitate veterans with Severe Mental Illness (SMI) better than a Wellness Lifestyle Program (WLP). It measures how well participants function in daily life activities like socializing and working. The study also looks at cognitive abilities and physical fitness as secondary outcomes.

How Is the Trial Designed?

Group I: Yoga-based Exercise (YE) Experimental Treatment 1 Intervention

The Yoga-based Exercise (YE) intervention is a series of yoga-based poses that consists of sitting, standing, kneeling, and lying postures as well as breathing exercises. The duration of the intervention will be 12 months. Participants will engage in yoga-based exercise sessions lasting 60 minutes twice a week for the first 12 weeks (3 months) of the project. The following 12 weeks, participants will engage in yoga-based exercises once a week. The remainder of the study (6 months), participants will engage in yoga-based exercises once a month.

Group II: Wellness Lifestyle Program (WLP) Active Control 1 Intervention

The Wellness Lifestyle Program (WLP) is a comprehensive lifestyle program that consists of 30 minutes of educational information covering various topics, such as nutrition, healthy living, stress reduction, and more will be followed by 30 minutes of low-intensity exercise such as walking. The duration of the intervention will be 12 months. Participants will engage in the 60 minute WLP session twice a week for the first 12 weeks (3 months) of the project. The following 12 weeks, participants will engage in WLP sessions once a week. The remainder of the study (6 months), participants will engage in WLP sessions once a month.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A systematic review of 19 studies suggests that aerobic exercise can benefit individuals with schizophrenia by improving both positive symptoms (like hallucinations) and negative symptoms, with effects potentially noticeable shortly after starting the program.

Despite the promising results, the studies often had small sample sizes and methodological weaknesses, highlighting the need for larger, well-designed trials to confirm the efficacy and safety of exercise as a treatment for schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Benefits of exercise for people with schizophrenia: a systematic review]. Bernard, P., Ninot, G.[2018]

An 11-week lifestyle intervention involving high-intensity interval training and health education was feasible for 16 participants with schizophrenia spectrum disorders, with over 70% attendance in both components.

The intervention led to significant improvements in physical activity and reductions in sedentary behavior, which were maintained at an 11-week follow-up, highlighting the potential for lifestyle changes to address cardiovascular risk factors in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Sound Body: Open Trial Results of a Group Healthy Lifestyle Intervention for Young Adults with Psychosis. Browne, J., Cather, C., Zvonar, V., et al.[2021]

Exercise interventions have shown positive health outcomes for hospitalized patients with depression, based on a systematic review of eight studies, indicating that exercise can be beneficial in acute mental health settings.

However, the evidence for the effectiveness of exercise in hospitalized patients with schizophrenia, bipolar disorder, or anxiety disorders is limited, highlighting a need for more research to determine the best exercise approaches for these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for mental illness: a systematic review of inpatient studies. Stanton, R., Happell, B.[2018]

An exercise program for individuals with serious mental illness was found to be feasible, with regular attendance from participants who self-selected to join the exercise group, which met three times a week for 50 minutes.

Both the exercise group (N=38) and the control group (N=28) showed similar improvements in symptoms and psychological well-being, indicating that exercise can be an effective adjunct treatment, although demographic factors influenced participation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An adjunct exercise program for serious mental illness: who chooses to participate and is it feasible? Sylvia, LG., Kopeski, L., Brown, C., et al.[2021]

A 10-week lifestyle intervention combining dietary changes and exercise was feasible and safe for 42 participants with severe mental illness, showing high recruitment (68%) and retention (77%) rates without serious adverse events.

Participants experienced significant improvements in functional exercise capacity and psychiatric symptoms, although motivation for exercise decreased over time, suggesting the need for longer interventions to maintain engagement and improve metabolic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Student-Led Lifestyle (Diet and Exercise) Intervention Within a Residential Rehabilitation Setting for People With Severe Mental Illness, GO HEART (Group Occupation, Health, Exercise And Rehabilitation Treatment). Korman, N., Fox, H., Skinner, T., et al.[2022]

In a study of 401 patients with severe mental disorders, only 29.4% reported engaging in regular physical activity, highlighting a significant gap in healthy lifestyle behaviors that could impact their recovery and overall health.

Patients with metabolic syndrome were more likely to engage in physical activity, while those with higher anxiety and depressive symptoms were less likely, suggesting that targeted psychoeducational interventions could help improve physical health and reduce mortality rates in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Complex Interplay Between Physical Activity and Recovery Styles in Patients With Severe Mental Disorders in a Real-World Multicentric Study. Sampogna, G., Luciano, M., Di Vincenzo, M., et al.[2022]

Individuals with severe mental illness have a significantly shorter life expectancy, losing 10 to 20 years compared to the general population, highlighting a critical public health issue.

There is a pressing need for clinical programs and research focused on the role of exercise in improving health outcomes for this population, as current integration of exercise into treatment plans is minimal despite its known benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on mortality rates of individuals with severe mental illness. Baron, DA., Mishrekar, A., Kazmi, S.[2022]

A quality improvement project involving 69 veterans with severe mental illness (SMI) implemented a personalized pedometer program, resulting in an average weight loss of 9 lbs over 2 months.

The program also significantly improved blood pressure control, with the percentage of veterans achieving controlled blood pressure increasing from 60% to 84%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing physical activity for veterans in the Mental Health Intensive Case Management Program: A community-based intervention. Harrold, SA., Libet, J., Pope, C., et al.[2018]

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