Brain Health and Exercise in Schizophrenia (PEHP)
This study is enrolling participants by invitation only.
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 (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
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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.
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) |
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 (Adult) |
| 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
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
| 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:
|
Schizophrenia Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |
ClinicalTrials.gov processed this record on September 29, 2016