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 is a hybrid1, effectiveness-implementation study of yoga-based exercises (YE) as an adjunctive tool for rehabilitation among persons with Severe Mental Illness (SMI). The two-arm randomized controlled trial will compare the efficacy of YE compared to the Wellness Lifestyle Program (WLP). Primary outcomes of the study will be self-report and performance-based measures of community functioning, defined in the investigators study as social, leisure, employment, and life skills functioning in the community. Secondary outcomes will include cognition and physical fitness measures.

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 exercise safe for people with severe mental illness?

Exercise programs for people with severe mental illness are generally considered safe and can offer health benefits, but more research is needed to standardize reporting and assess any potential adverse events. ^{1 2 3 4 5}

How is the Wellness Lifestyle Program treatment different from other treatments for severe mental illness?

The Wellness Lifestyle Program is unique because it integrates exercise as a key component of treatment for severe mental illness, addressing both physical and mental health by reducing risks associated with poor nutrition, low fitness, and inactivity, which are common in this population. Unlike traditional treatments that may focus solely on medication or therapy, this program emphasizes lifestyle changes to improve overall well-being and reduce premature mortality. ^{2 3 4 6 7}

What data supports the effectiveness of the treatment Wellness Lifestyle Program, Yoga-based Exercise, Yoga Therapy, and Mind-Body Exercise for severe mental illness?

Research shows that exercise and lifestyle interventions can improve physical health and reduce risks like heart disease and diabetes in people with severe mental illness. Exercise programs have been found to be feasible and can lead to positive changes in physical activity and well-being, although more research is needed to determine the best ways to deliver these programs. ^{1 2 3 4 8}

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

Clinical global impression-severity (CGI-S) scores mild to moderately ill

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

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]

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]

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 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]

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]

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]

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]

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]

Citations

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

Developing a Sound Body: Open Trial Results of a Group Healthy Lifestyle Intervention for Young Adults with Psychosis. [2021]

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

An adjunct exercise program for serious mental illness: who chooses to participate and is it feasible? [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of exercise on mortality rates of individuals with severe mental illness. [2022]

4. Switzerland 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). [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Exercise for mental illness: a systematic review of inpatient studies. [2018]

6. Switzerland 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. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Benefits of exercise for people with schizophrenia: a systematic review]. [2018]

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

Increasing physical activity for veterans in the Mental Health Intensive Case Management Program: A community-based intervention. [2018]