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ClinicalTrials.gov Identifier: NCT01392885
Enrolling by invitation
: July 13, 2011
Last Update Posted
: January 18, 2018
BC Mental Health and Addictions Research Institute
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
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
SchizophreniaSchizoaffective DisorderPoor Memory
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.
Increase hippocampal volume with aerobic training in schizophrenic and healthy volunteers. [ Time Frame: 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
Increases in hippocampal volumes will be positively associated with improvements in working memory performance in schizophrenia. [ Time Frame: 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.
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Ages Eligible for Study:
19 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
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