Brain Health and Exercise in Schizophrenia (PEHP)
This study is not yet open for participant recruitment.
(see Contacts and Locations)
Verified January 2011 by BC Mental Health and Addictions Research Institute
Sponsor:
BC Mental Health and Addictions Research Institute
Collaborators:
University of British Columbia
Simon Fraser University
Canadian Institutes of Health Research (CIHR)
Information provided by:
BC Mental Health and Addictions Research Institute
ClinicalTrials.gov Identifier:
NCT01392885
First received: June 21, 2011
Last updated: July 12, 2011
Last verified: January 2011
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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.
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Schizophrenia, schizoaffective |
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 Riverview Hospital or 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392885
Contacts
| Contact: Barbara G Humphries | 604-524-7844 | b1619@telus.net |
Locations
| Canada, British Columbia | |
| Riverview Hospital | Not yet recruiting |
| Coquitlam, British Columbia, Canada, V3C 4J2 | |
| Contact: Barbara G Humphries 604-524-7844 b1619@telus.net | |
| Contact: Donna J Lang, PhD 604-875-2000 ext 4727 dlang@interchange.ubc.ca | |
| Sub-Investigator: Sean Flynn, Ass. Prof | |
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, BC Mental Health and Addictions Services, University of British Columbia, Centre for Complex Disorders |
| ClinicalTrials.gov Identifier: | NCT01392885 History of Changes |
| Other Study ID Numbers: | 231233-BSB |
| Study First Received: | June 21, 2011 |
| Last Updated: | July 12, 2011 |
| 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 February 27, 2015