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RecruitingNCT01392885PEHPUpdated Jun 8, 2023

Brain Health and Exercise in Schizophrenia

An observational study in Schizophrenia, Schizoaffective Disorder and Poor Memory, sponsored by BC Mental Health and Addictions Research Institute. Recruiting at 1 site in Canada. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-08.

Sponsored by BC Mental Health and Addictions Research Institute · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
19 Years to 45 Years
Sex
All
01

Study 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. Poor fitness and associated neurovascular deficits may arise from various sources, including poor mental health, adverse side effects of antipsychotic medications and independent cardiovascular deficits that may be due to neurodevelopmental abnormalities in patients with schizophrenia. These factors are likely contributing to markedly increased stroke risk and early mortality. These problems are not well addressed by current clinical treatments, nor is neurovascular stroke risk readily or accurately detected in clinic.In contrast, 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, while reducing the risk of stroke. 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. Additionally, baseline and follow-up stroke risk will be assessed using a novel non-invasive approach of retinal imaging to determine the presence of underlying neurovascular pathology.

Read the 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 = 30 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 and to establish differences in retinal vessel integrity between patients and healthy volunteers. All training will be conducted at the UBC Hospital and at dedicated exercise training facilities at the University of British Columbia. All fitness assessments (based on the initial 6-minute walk test) and 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.

Clinical data (current medications, current diagnoses, symptom profiles, resting heart rate, blood pressure, weight) will be collected on the hospital wards at baseline and follow-up. Neuroimaging and retinal imaging will be ascertained at the UBC MRI Research Centre at baseline and follow-up. Concurrent baseline assessments of executive functioning, memory capacity and crystallized IQ will be performed at baseline. Cognitive measures, excluding IQ, will be re-assessed at follow-up. Follow-up measures will only be collected in cases were patients are still available and willing to participate in study activities.

02

Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder
  • Poor Memory

Keywords

  • Schizophrenia
  • Schizoaffective Disorder
  • Brain Health
  • Exercise
  • Mental Health
  • Poor memory
03

In context

Schizophrenia

3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.

This study's planned enrollment of 60 is below the median of 178 across 503 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

This is the only study on the registry with BC Mental Health and Addictions Research Institute as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Increase hippocampal volume with aerobic training in schizophrenic and healthy volunteers.

    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

    Time frame: Base-line, 8 and 12 weeks

Secondary outcomes

  1. Increases in hippocampal volumes will be positively associated with improvements in working memory performance in schizophrenia.

    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.

    Time frame: Baseline, Week 4, 8 and 12.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Woodward ML, Gicas KM, Warburton DE, White RF, Rauscher A, Leonova O, Su W, Smith GN, Thornton AE, Vertinsky AT, Phillips AA, Goghari VM, Honer WG, Lang DJ. Hippocampal volume and vasculature before and after exercise in treatment-resistant schizophrenia. Schizophr Res. 2018 Dec;202:158-165. doi: 10.1016/j.schres.2018.06.054. Epub 2018 Jun 29. PubMed 30539767 ↗
  • Kim DD, Lang DJ, Warburton DER, Woodward ML, White RF, Barr AM, Honer WG, Procyshyn RM. Heart-rate response to alpha2-adrenergic receptor antagonism by antipsychotics. Clin Auton Res. 2017 Dec;27(6):407-410. doi: 10.1007/s10286-017-0444-4. Epub 2017 Jul 3. PubMed 28674870 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2011, a primary completion of Jun 2026 and a completion of Dec 2026. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2011
First posted
Jul 13, 2011
Start
Jul 2011
Primary completionEst.
Jun 2026
CompletionEst.
Dec 2026
Last update
Jun 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01392885
Lead sponsor
BC Mental Health and Addictions Research Institute
Collaborators
University of British Columbia, Simon Fraser University, Canadian Institutes of Health Research (CIHR)
Responsible party
Dr. Donna Lang, PhD (Dr. Donna J. Lang, PhD, BC Mental Health and Addictions Research Institute) — Principal investigator
First posted
Jul 13, 2011
Start date
Jul 2011
Primary completion
Jun 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 8, 2023

Study contacts

Donna J Lang, PhD
Contact
donna.lang@ubc.ca
604-875-2000 ext. 4727
Donna J Lang, PhD
principal investigator · University of British Columbia, Dept. of Radiology
William G Honer, Professor
study chair · University of British Columbia, Dept of Psychiatry
Allen Thornton, Unspecified
study chair · Simon Fraser University
Darren Warburton, Ass. Prof
study chair · University of British Columbia, Dept. of Human Kinetics
Alexandra T Vertinsky, Clin. Instr.
study chair · University of British Columbia, Dept. of Radiology
Alexander Rauscher, Ass. Prof.
study chair · University of British Columbia, Dept. of Radiology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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