Exercise Programs for Veterans with Severe Mental Illness

This study is looking at how two different programs can help Veterans with severe mental illnesses like schizophrenia, schizoaffective disorder, or bipolar 1 disorder. One program is Yoga-based Exercise (YE), which involves yoga poses and breathing. The other is the Wellness Lifestyle Program (WLP), which includes educational topics and low-intensity exercise like walking. Researchers want to see if these programs can improve your social functioning and quality of life. You might be able to join if you are a Veteran between 18 and 70 years old with one of these diagnoses, even if you also have a history of alcohol or substance use disorder. The study aims to enroll 112 participants.

Study design
This is a randomized controlled trial comparing two interventions. It plans to enroll 112 participants.
What's involved
You would participate in either the Yoga-based Exercise or the Wellness Lifestyle Program for 12 months.
Compensation
Not stated in the trial record.
Follow-up
Your social functioning, quality of life, and other measures will be assessed at 12 months.

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NCT05157620

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

Recruiting
NAAges 18–70InterventionalTreatment
VA Office of Research and Development
~112 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Yoga-based Exercise (YE)Wellness Lifestyle Program (WLP)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Social Functioning Scale (SFS)
Measured over 12 months
+2 more outcomes measured
Schizophrenia
Schizoaffective
Bipolar Disorder 1
1 sites across 1 states
Pennsylvania1
  • Vishwajit Laxmikant Nimgaonkar, MD PhD · PRINCIPAL_INVESTIGATOR · VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

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Eligibility criteria

Inclusion

Written informed consent;
age 18-70 years;
DSM-5 diagnosis of
schizophrenia,
schizoaffective disorder,
bipolar 1 disorder,
DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar 1 disorder including those with a co-morbid
alcohol use disorder or substance use disorder;
clinically stable;
clinical global impression-severity (CGI-S) scores mild to moderately ill

Exclusion

Unable to provide written informed consent;
intellectual disability (i.e., severe enough to impact understanding of yoga-based exercises) based on chart or IQ\<80 on the Wechslet Abbreviated Scale of Intelligence-II (WASI-II);
disability or illness precluding yoga-based exercises or wellness lifestyle program, e.g.,
current or recent angina (\<6 months),
history of myocardial infarction in the past year (unless permission is obtained from the primary care physician),
uncontrolled hypertension or hypotension;
neurological illness complicating diagnosis / cognitive evaluation, e.g.,
dementia,
stroke or head injury;
physical problems that preclude training for yoga-based exercises / wellness lifestyle program, e.g.,
severely impaired vision;
ongoing treatment that includes more than one hour per week of relaxation and mind-body based stress reduction strategies related to yoga
  • Social Functioning Scale (SFS)12 months

    The Social Functioning Scale (SFS) is a self-report measure of social functioning, and is widely used in adults with psychosis.

  • Patient-Reported Outcomes Measurements Information Systems (PROMIS)12 months

    Patient-Reported Outcomes Measurements Information System's (PROMIS) Satisfaction with Participation in Social Roles and Activities will be used to assess participant's perceived satisfaction with their social roles and activities as part of the community and social functioning outcome. The PROMIS scale is an 8-item short form. The scale for each item is: Not at all, a little bit, somewhat, quite a bit, very much.

  • Quality of Life Scale (QOL)12 months

    The Quality of Life Scale (QOL) will be used to measure interpersonal, social and occupational functioning. The QOL scale is a 16-item scale ranging from 1-7. 1= Terrible, 2 = Unhappy, 3 = Mostly dissatisfied, 4= Mixed, 5 = Mostly satisfied, 6 = Pleased, 7= Delighted