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RecruitingNot ApplicableNCT05157620

Exercise-based Program for Rehabilitation of Veterans With Severe Mental Illness

Sponsor

VA Office of Research and Development

Enrollment

112 participants

Start Date

Oct 24, 2022

Study Type

INTERVENTIONAL

Conditions

SchizophreniaSchizoaffectiveBipolar Disorder 1

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an exercise and yoga-based rehabilitation program for veterans living with serious mental illnesses such as schizophrenia, schizoaffective disorder, or bipolar disorder. The goal is to improve physical and mental wellbeing through structured movement and wellness activities. **You may be eligible if...** - You are a veteran aged 18–70 years - You have a diagnosis of schizophrenia, schizoaffective disorder, or bipolar 1 disorder - Your condition is currently stable (mild to moderately ill) - You may also have a co-occurring substance or alcohol use disorder **You may NOT be eligible if...** - You cannot provide informed consent - You have an intellectual disability (IQ below 80) that would prevent you from participating in yoga exercises - You have a physical condition (e.g., recent heart problems, uncontrolled blood pressure) that prevents exercise - You have dementia, stroke, or other neurological conditions - You have severely impaired vision - You already spend more than one hour per week in yoga or mind-body stress reduction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERYoga-based Exercise (YE)

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.

OTHERWellness Lifestyle Program (WLP)

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.

Locations(1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

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NCT05157620

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