Brain Health and Exercise in Schizophrenia (PEHP)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of British Columbia
Simon Fraser University
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Donna Lang, PhD, BC Mental Health and Addictions Research Institute
ClinicalTrials.gov Identifier:
NCT01392885
First received: June 21, 2011
Last updated: July 20, 2015
Last verified: July 2015
  Purpose

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
Schizophrenia
Schizoaffective Disorder
Poor Memory

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Health: Effects of Exercise on Hippocampal Volume and Memory Deficits in Persons With Schizophrenia

Resource links provided by NLM:


Further study details as provided by BC Mental Health and Addictions Research Institute:

Primary Outcome Measures:
  • Increase hippocampal volume with aerobic training in schizophrenic and healthy volunteers. [ Time Frame: Base-line, 8 and 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Increases in hippocampal volumes will be positively associated with improvements in working memory performance in schizophrenia. [ Time Frame: Baseline, Week 4, 8 and 12. ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

No Biospecimens to be retained


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: December 2016
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Sixty in-patients with chronic schizophrenia will be recruited at UBC Hospital and 60 age and gender-matched healthy (asymptomatic) community volunteers will be recruited through local community paper advertisements or posters at local community centres.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392885

Locations
Canada, British Columbia
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
  More Information

No publications provided

Responsible Party: Dr. Donna Lang, PhD, Dr. Donna J. Lang, PhD, BC Mental Health and Addictions Research Institute
ClinicalTrials.gov Identifier: NCT01392885     History of Changes
Other Study ID Numbers: 231233-BSB
Study First Received: June 21, 2011
Last Updated: July 20, 2015
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

Keywords provided by BC Mental Health and Addictions Research Institute:
Schizophrenia
Schizoaffective Disorder
Brain Health
Exercise
Mental Health
Poor memory

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 31, 2015