Recruiting

Exercise-Based Program

Sponsor:

VA Office of Research and Development

Code:

NCT05157620

Conditions

Schizophrenia

Schizoaffective

Bipolar Disorder 1

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Yoga-based Exercise (YE)

Wellness Lifestyle Program (WLP)

Study Details

Brief 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.

Conditions

Schizophrenia

Schizoaffective

Bipolar Disorder 1

Study ID

NCT05157620

Start date

Oct 24, 2022

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

112 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Yoga-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.

active comparator: Wellness 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.

Interventions

Yoga-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.

Wellness 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.

Primary outcome measure

  • Social Functioning Scale (SFS) [ Time Frame: 12 months ]
  • Patient-Reported Outcomes Measurements Information Systems (PROMIS) [ Time Frame: 12 months ]
  • Quality of Life Scale (QOL) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Vishwajit L Nimgaonkar, MD PhD

(412) 688-6000Vishwajit.Nimgaonkar@va.gov

Locations

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Recruiting

Pittsburgh, Pennsylvania, United States, 15240

Contacts

Vishwajit L Nimgaonkar, MD PhD

(412) 688-6000Vishwajit.Nimgaonkar@va.gov

Principal Investigator:

Vishwajit Laxmikant Nimgaonkar, MD PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • schizophrenia
  • psychotic disorders
  • schizoaffective
  • bipolar disorder 1
  • exercise
  • yoga
  • community function
  • quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-07-01.