Schizophrenia Mental and Behavioural Disorders Schizophrenia
Conditions
Interventions
Patients randomized to the control group were offered occupational therapy (OT) biweekly for six months. OT comprised creative, recreational and social activities such as painting and computer activit
main muscle groups
3 times 10 to 15 repetitions maximum) were included to provide variation in the physical exercise program. The program followed recommendations of the American College of Sports Medicine (ACSM
American College of Sports Medicine, 1998
Kraemer et al., 2002). The exercise program was registered in the subject?s logbook, providing information on amount of training and compliance. Ex subjects, both patients and controls, exercised one
week 4-12: 65%
week 13-26: 75% of Vo2-reserve (Vo2-R)) (ACSM, 1998). Individual workload of each participant was determined according patients hear rate reserve as determined by the baseline Maximal Exercise Toleran
Sponsors
University Medical Center Utrecht (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria to be eligible for enrolment: 1. Diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder according to Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) and assessed with the Comprehensive Assessment of Schizophrenia and History (CASH) (Andreasen et al., 1992). 2. 18 - 48 years old 3. Stable on antipsychotic medication 4. Written informed consent Healthy control subjects must meet the following criteria to be eligible for enrolment: 1. No diagnosis of a psychiatric disorder according to DSM-IV ever 2. 18 - 48 years old 3. Matching amount of physical activity compared to included patients, as measured before intervention by the SenseWear PRO2 Body Monitoring System 4. Matching level of parental education compared to included patients, as measured before intervention by means of the verhage method 5. Matching body mass index (BMI) compared to included patients, as measured before intervention 6. No first degree relative with a psychotic or depressive disorder 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Evidence of significant cardiovascular disorders that might prevent safe participation in the study. Risk of cardiovascular disorders will be assessed following Lausanne recommendations 2. Evidence of significant neuromuscular or endocrine, or other disorders (for example joint disease) that might prevent safe participation in this study 3. A primary diagnosis of alcohol or substance abuse 4. intelligence quotient (IQ) < 70, as measured with Wechsler Adult Intelligence Scale Short Form (WAIS-III SF): short version of the WAIS-III, gives an estimate of an individual?s intellectual functioning. 5. Organic brain disorder or other clinically significant concurrent medical illness 6. Severe head trauma 7. With occurrence of certain medical diseases (for example fever) a subject can be temporarily be excluded from the intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate whether a 6-month cardiovascular exercise program will provide greater improvement on the following symptomatology and cardiovascular fitness than occupational therapy measurements in patients with schizophrenia. Another primary objective is to examine whether the reported progressive brain volume decreases in schizophrenia will diminish more through a 6-month cardiovascular exercise program than occupational therapy as measured by MRI. 1. Symptomatology measurements: 1.1. Positive and Negative Syndrome Scale (PANSS): This test is a 30-item rating scale designed to measure severity of psychopathology in adult patients with schizophrenia. Five components have been reported: positive, negative, depression, agitation-excitement, and disorganisation (Wolthaus et al., 2000;Bell et al., 1994). 1.2. Clinical Global Impression Scale (CGI): measure the clinical global impression by means of two scales, one for present state and one for change 2. Physical measurements: Maximal Exercise Tolerance Test (METT): Each subject will undergo an exercise test according to the Godfrey-protocol bicycle ergometer test. The maximum oxygen uptake capacity (VO2max) can be determined validly and reliably with this protocol. After two minutes of biking at 50 watt the workload is increased by 20 watt?s every minute until exhaustion is reached. Ventilation, oxygen consumption and expired carbon dioxide (CO2) are measured. 3. MRI measures: Volume measurements: Quantitative assessments of intracranial, total brain, gray and white matter of the cerebrum (total brain excluding cerebellum and stem), lateral and third ventricles, and peripheral cerebrospinal fluid (CSF) volumes will be performed All measurements are performed at baseline (before randomisation) and immediately after the six month intervention period. All measurements are assessed by a rater, blinded for randomisation, within 14 days, and all measurements are assessed within 7 days prior or after assessment of the Posi | — |
Secondary
| Measure | Time frame |
|---|---|
| To examine whether a 6-month cardiovascular exercise program will provide greater improvement on psychiatric and somatic co-morbidity than occupational therapy in patients with schizophrenia. Also, a secondary objective of this study is to examine whether changes are found in binary masks of gray and white matter and in intensities of white-matter nervous paths between regions of interest as measured by MRI. The following assessments will be done as secondary objectives: 1. Psychiatric co-morbidity measurements: 1.1. Montgomery and Asberg Depression Rating Scale (MADRS): degree of severity of depressive symptoms, sensitive measure of change in symptom severity during treatment 1.2. Cumulative antipsychotic medication: cumulative life-time antipsychotic medication in haloperidol (mg) equivalent 1.3. Number of hospitalisations: number and duration of hospitalisations (days) between T0 and T6 1.4. Camberwell Assessment of Need (CAN): assesses the community services requirements of patients with severe mental illness. Has the ability to aid routine care and treatment and highlights likely areas for further assessment 1.5. Quality of Life-Short version (QLS): measures general physical condition, important human activities, and general quality of life 1.6. Continuous Performance Test, Identical Pairs Version (CPT-IP): assesses more complex attention-dependent task requiring formation and transient maintenance of a representation of task relevant information for correct task performance 1.7. Auditory Verbal Learning Test (AVLT): multiple measures of immediate and delayed ability to recall presented visual information (words) and recognition of formerly presented information 1.8. Digit-Symbol Task (DST): is regarded as a measure primarily of speed of information processing, although it also reflects psychomotor speed and short-term memory 2. Somatic co-morbidity measurements: 2.1. Body Mass Index 2.2. Amount of daily physical activity (measured with SenseWear PRO2 Body M | — |
Countries
Netherlands
Outcome results
None listed