RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-24
Study Completion:2026-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05157620

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Written informed consent;
  2. * age 18-65 years;
  3. * DSM-5 diagnosis of
  4. * schizophrenia,
  5. * schizoaffective disorder,
  6. * bipolar 1 disorder,
  7. * DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar 1 disorder including those with a co-morbid
  8. * alcohol use disorder or substance use disorder;
  9. * clinically stable;
  10. * no psychoactive medication changes for past 4 weeks;
  11. * clinical global impression-severity (CGI-S) scores mild to moderately ill
  1. * Unable to provide written informed consent;
  2. * 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);
  3. * disability or illness precluding yoga-based exercises or wellness lifestyle program, e.g.,
  4. * current or recent angina (\<6 months),
  5. * history of myocardial infarction in the past year (unless permission is obtained from the primary care physician),
  6. * uncontrolled hypertension or hypotension;
  7. * neurological illness complicating diagnosis / cognitive evaluation, e.g.,
  8. * dementia,
  9. * stroke or head injury;
  10. * physical problems that preclude training for yoga-based exercises / wellness lifestyle program, e.g.,
  11. * severely impaired vision;
  12. * ongoing treatment that includes more than one hour per week of relaxation and mind-body based stress reduction strategies related to yoga

Contacts and Locations

Study Contact

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

Principal Investigator

Vishwajit Laxmikant Nimgaonkar, MD PhD
PRINCIPAL_INVESTIGATOR
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Locations (Sites)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Vishwajit Laxmikant Nimgaonkar, MD PhD, PRINCIPAL_INVESTIGATOR, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-24
Study Completion Date2026-05-31

Study Record Updates

Study Start Date2022-10-24
Study Completion Date2026-05-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Schizophrenia
  • Schizoaffective
  • Bipolar Disorder 1