PEHP: Brain Health and Exercise in Schizophrenia

Sponsor
BC Mental Health and Addictions Research Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT01392885
Collaborator
University of British Columbia (Other), Simon Fraser University (Other), Canadian Institutes of Health Research (CIHR) (Other)
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Study Details

Study Description

Brief Summary

To determine the effects of aerobic exercise on hippocampal volumes and severity of psychotic symptoms in a population of psychosis patients compared to healthy age/gender matched volunteers. Psychosis patients often suffer from a number of cognitive difficulties, including poor memory function, poor problem-solving capacity and difficulties with attention and concentration. These problems are not well addressed by current clinical treatments. Evidence from aging research strongly suggests that increased cardiovascular fitness may provide numerous cognitive benefits by promoting brain growth, particularly in the frontal lobes and the hippocampi. The current study will measure the effects of aerobic exercise on brain volumes in a population of chronic psychosis patients to determine if 1) hippocampal volumes increase in response to exercise and 2) if parallel improvements in cognitive functioning occur.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a 12-week, randomized trial with two parallel groups. Throughout the trial, subjects will be treated on their prescribed dose of medication. Once informed consent is obtained, subjects and healthy volunteers will be randomly assigned to either an aerobic or a resistance exercise program (N = 24 per diagnostic group in each of two exercise conditions). Patients will continue to receive their antipsychotics and other prescribed medications. Healthy volunteer data will be used to establish normal exercise-induced neuroplasticity in a non-psychiatric, non-medicated population. All training will be conducted at the Riverview Hospital fitness facilities and at dedicated exercise training facilities at the University of British Columbia. All exercise sessions will be monitored by trained research assistants (RAs) under the guidance of the Canadian Society for Exercise Physiology-Certified Exercise Physiologists (CSEP-CEPs). The RAs will receive pre-study exercise training from the CSEP-CEPs. During the course of the study, the training intensity will be changed according to the individual participant's response and needs via the CSEP-CEPs and RAs.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Brain Health: Effects of Exercise on Hippocampal Volume and Memory Deficits in Persons With Schizophrenia
    Study Start Date :
    Jul 1, 2011
    Actual Primary Completion Date :
    Jun 1, 2016
    Anticipated Study Completion Date :
    Dec 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Increase hippocampal volume with aerobic training in schizophrenic and healthy volunteers. [Base-line, 8 and 12 weeks]

      Hippocampal volumes will be measured from structural MRI scans. T1-weighted 3D SPGR (spoiled gradient recalled) and high-resilution T2- weighted structural images will be obtained for the purposes of volumetric assessment of the hippocampi and the whole brain

    Secondary Outcome Measures

    1. Increases in hippocampal volumes will be positively associated with improvements in working memory performance in schizophrenia. [Baseline, Week 4, 8 and 12.]

      The Hopkins Verbal Learning Test (HVLT), will be used to assess memory function. Multiple versions of the HVLT exist (12) so practice effects will be minimized. The Rey-Osterrieth Complex Figure Test (ROCF), in which subjects are asked to reproduce a complex line drawing from memory, will be used to assess attention and working memory.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age 19 to 45 years

    • Able to provide written, informed consent in English

    • Patients may be on prescribed medications

    • DSM-IV diagnosis of schizophrenia or schizoaffective disorder

    • Normal visual acuity (or normal visual acuity achievable with corrective lenses)

    • Physical ability to be engaged in a regular exercise program

    Exclusion Criteria:
    • A history of organic disorders (dementia, severe head injury, or developmental disorders such as autism, mental retardation, Down's Syndrome)

    • A current DSM-IV diagnosis of substance dependence (during prior 12 months, excluding tobacco)

    • Any history of DSM-IV diagnoses (Axis I) for other psychiatric disorders

    • History of angina, heart attack or transient ischemic attacks

    • Non-independent mobility or limb prostheses

    • A history of severe head injury leading to loss of consciousness for > 5 minutes

    • Contra-indications for neuroimaging (metal implants, non-removable orthodontic devices, severe claustrophobia, pregnancy, or surgeries within the previous 6 months)

    • Currently already enrolled in a regular exercise program

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UBC Hospital Vancouver British Columbia Canada V6T 1Z3

    Sponsors and Collaborators

    • BC Mental Health and Addictions Research Institute
    • University of British Columbia
    • Simon Fraser University
    • Canadian Institutes of Health Research (CIHR)

    Investigators

    • Principal Investigator: Donna J Lang, PhD, University of British Columbia, Dept. of Radiology
    • Study Chair: William G Honer, Professor, University of British Columbia, Dept of Psychiatry
    • Study Chair: Allen Thornton, Unspecified, Simon Fraser University
    • Study Chair: Darren Warburton, Ass. Prof, University of British Columbia, Dept. of Human Kinetics
    • Study Chair: Alexandra T Vertinsky, Clin. Instr., University of British Columbia, Dept. of Radiology
    • Study Chair: Sean Flynn, Ass. Prof., University of British Columbia, Dept. of Psychiatry
    • Study Chair: Alexander Rauscher, Ass. Prof., University of British Columbia, Dept. of Radiology
    • Study Chair: Geoffrey N Smith, Ass. Prof, University of British Columbia, Dept. of Psychiatry

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Donna Lang, PhD, Dr. Donna J. Lang, PhD, BC Mental Health and Addictions Research Institute
    ClinicalTrials.gov Identifier:
    NCT01392885
    Other Study ID Numbers:
    • 231233-BSB
    First Posted:
    Jul 13, 2011
    Last Update Posted:
    Jan 18, 2018
    Last Verified:
    Jan 1, 2018
    Keywords provided by Dr. Donna Lang, PhD, Dr. Donna J. Lang, PhD, BC Mental Health and Addictions Research Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 18, 2018