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

NCT05157620 | Recruiting DMC

• 1 other identifier: D3622-R
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

  NOTE: The VA and the copyright holder of this assessment have not come to an agreement allowing the study to purchase rights to use this measure. We are still negotiating as of this date (10/18/2023), and so are not removing it from ART. We are adding another measure to take it's place if we remain unable to procure it, called the Social Functioning Scale (SFS) . Community (social) functioning is the primary outcome measured from the VRFCAT. The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) is a computerized measure that assesses functional capacity with the potential to demonstrate real-world functional improvements. The VRFCAT generates a composite score.

  12 months

• Patient-Reported Outcomes Measurements Information Systems (PROMIS)

  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.

  12 months

• Quality of Life Scale (QOL)

  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

  12 months

• Social Functioning Scale (SFS)

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

  12 months

Secondary Outcomes (7)

• Clinical Global Impression-Severity (CGI-S)

  12 months

• Brief Assessment of Cognition (BAC)

  12 month

• 2-minute walk

  12 months

• Patterns of utilization

  12 months

• Brief Psychiatric Rating Scale (BPRS)

  12 months

Study Arms (2)

Yoga-based Exercise (YE)

EXPERIMENTAL

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.

Other: Yoga-based Exercise (YE)

Wellness Lifestyle Program (WLP)

ACTIVE COMPARATOR

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.

Other: Wellness Lifestyle Program (WLP)

Interventions

Yoga-based Exercise (YE) OTHER

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.

Yoga-based Exercise (YE)

Wellness Lifestyle Program (WLP) OTHER

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.

Wellness Lifestyle Program (WLP)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior

Study Officials

• Vishwajit Laxmikant Nimgaonkar, MD PhD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vishwajit L Nimgaonkar, MD PhD

CONTACT

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

Gretchen L Haas, PhD

CONTACT

(412) 360-2662; Gretchen.Haas@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research staff conducting assessments will not be informed as to which group each participant has been assigned. Additionally, investigators will be be masked to groups, except for Dr. Bramoweth. Dr. Bramoweth will be conducting qualitative interviews with participants enrolled in the YE group only. He will be masked to all other participants except those participating in the qualitative interviews.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled trial. Participants will be randomized to either a Yoga-based exercise intervention or a Wellness Lifestyle Program intervention. Both interventions will be conducted simultaneously.

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 15, 2021
• Study Start: October 24, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)