Schizophrenia
Conditions
Keywords
Schizophrenia, Exercise, Cognition
Brief summary
This study will evaluate the ability of aerobic exercise (AE) to improve cognition in people with schizophrenia. Participants will be randomly assigned to one of two interventions: (1) aerobic exercise class (stationary bicycle, or spin class) for up to 45 minutes three times per week for 12 weeks, or (2) balance and stretching class for up to 45 minutes three times per week for 12 weeks.
Detailed description
Schizophrenia (SCZ) is a severe, chronic, and disabling psychotic illness that affects approximately 87,000 Veterans. Previous studies have reported improved short-term memory with AE, but there in a lack of information on cognitive effects of AE in SCZ. The investigators want to determine if twelve weeks of AE training improves cognitive function in Veterans with SCZ.
Interventions
BEHAVIORALAerobic Exercise
Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
BEHAVIORALBalance and Stretching
Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
Sponsors
Emory University
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of schizophrenia or schizoaffective disorder * maintained on stable doses of outpatient psychiatric medications for at least 30 days * compliant with outpatient follow-up * have a stable place to live * access to transportation to the hospital * doing less than 20 minutes per week of regular physical activity in the past month
Exclusion criteria
* Bipolar disorder; * active substance dependence within the prior 30 days * more than 2 psychiatric admissions within the prior six months * known HIV infection or AIDS * history of traumatic brain injury * current seizure disorder * Alzheimer's disease or other dementia * clinical history of mild cognitive impairment * Parkinson's disease * other current clinically significant neurological disease * unstable medical condition that would be expected to interfere with fitness training * significant hearing or visual impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Function, Assessed by Scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | Baseline, 12 weeks | Cognitive function will be assessed by using the MATRICS Consensus Cognitive Battery (MCCB). It assesses seven key cognitive domains: processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB is a battery of tests with a computerized scoring system that produces T-scores, adjusted for age and sex, that are used by the MCCB software to create composite scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better overall cognitive functioning. A higher composite score on the MCCB is indicative of better cognitive function, however there are no clinically significant thresholds. The scores reported below are means +/- standard deviations of these composite scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Ability | Baseline, 12 weeks | Functional ability will be assessed using the University of California San Diego Performance-Based skills assessment (UPSA). The UPSA is a measure of functional ability to perform common activities of daily living. It assess communication, financial, and household skills as well as the ability to manage medication, navigate transportation, and organize and plan an activity. Each measure creates a raw score which is summed to create a composite score. A higher score indicates better functional ability. No clinically significant thresholds. The maximum score an individual could obtain was 87 and the minimum was 0. The score is reported on scale units. |
| Change in MCCB Scores | Baseline, 20 weeks | Cognitive function will be assessed by using the MATRICS Consensus Cognitive Battery (MCCB). It assesses seven key cognitive domains: processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB is a battery of tests with a computerized scoring system that produces T-scores, adjusted for age and sex, that are used by the MCCB software to create composite scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. A higher composite score on the MCCB is indicative of better cognitive function, however there are no clinically significant thresholds. The scores reported below are means +/- standard deviations of these composite scores. |
| Change in Scores on the University of California San Diego Performance-Based Skills Assessment (UPSA) | Baseline, 20 weeks | Functional ability will be assessed using the University of California San Diego Performance-Based skills assessment (UPSA). The UPSA is a measure of functional ability to perform common activities of daily living. It assess communication, financial, and household skills as well as the ability to manage medication, navigate transportation, and organize and plan an activity. Each measure creates a raw score which is summed to create a composite score. A higher score indicates better functional ability. No clinically significant thresholds. The maximum score an individual could obtain was 87 and the minimum was 0. The score is reported on scale units. |
Countries
United States
Participant flow
Pre-assignment details
There is a discrepancy between the enrollment number (50) and the participant flow module (38) because 12 participants either failed the initial screening procedures or were unable to be randomized because they didn't complete the baseline visit prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Aerobic Exercise Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
Aerobic Exercise: Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. | 21 |
| Balance and Stretching Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
Balance and Stretching: Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. | 17 |
| Total | 38 |
Baseline characteristics
| Characteristic | Aerobic Exercise | Balance and Stretching | Total |
|---|---|---|---|
| 400m Walk Time | 358.95 seconds STANDARD_DEVIATION 58.022 | 345.38 seconds STANDARD_DEVIATION 57.218 | 353.08 seconds STANDARD_DEVIATION 57.279 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 17 Participants | 38 Participants |
| Age, Continuous | 52.524 years STANDARD_DEVIATION 6.66 | 53.176 years STANDARD_DEVIATION 10.273 | 52.816 years STANDARD_DEVIATION 8.239 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 17 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | 21 participants | 17 participants | 38 participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 16 Participants | 15 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 17 |
| other Total, other adverse events | 2 / 21 | 2 / 17 |
| serious Total, serious adverse events | 3 / 21 | 1 / 17 |
Outcome results
Primary
Change in Cognitive Function, Assessed by Scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Cognitive function will be assessed by using the MATRICS Consensus Cognitive Battery (MCCB). It assesses seven key cognitive domains: processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB is a battery of tests with a computerized scoring system that produces T-scores, adjusted for age and sex, that are used by the MCCB software to create composite scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better overall cognitive functioning. A higher composite score on the MCCB is indicative of better cognitive function, however there are no clinically significant thresholds. The scores reported below are means +/- standard deviations of these composite scores.
Time frame: Baseline, 12 weeks
Population: We had significant drop-out during the course of the 12 week exercise paradigm, therefore only 11 from the Aerobic group and 6 from the Balance and Stretching group completed all 12 weeks worth of exercise.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise | Change in Cognitive Function, Assessed by Scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | Baseline | 24.909 T-score | Standard Deviation 9.332 |
| Aerobic Exercise | Change in Cognitive Function, Assessed by Scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | 12 Weeks | 27.727 T-score | Standard Deviation 10.258 |
| Balance and Stretching | Change in Cognitive Function, Assessed by Scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | Baseline | 31.333 T-score | Standard Deviation 5.989 |
| Balance and Stretching | Change in Cognitive Function, Assessed by Scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | 12 Weeks | 32.833 T-score | Standard Deviation 6.113 |
Secondary
Change in Functional Ability
Functional ability will be assessed using the University of California San Diego Performance-Based skills assessment (UPSA). The UPSA is a measure of functional ability to perform common activities of daily living. It assess communication, financial, and household skills as well as the ability to manage medication, navigate transportation, and organize and plan an activity. Each measure creates a raw score which is summed to create a composite score. A higher score indicates better functional ability. No clinically significant thresholds. The maximum score an individual could obtain was 87 and the minimum was 0. The score is reported on scale units.
Time frame: Baseline, 12 weeks
Population: We had many individuals who dropped out during the course of the 12 week exercise program, this leads to the discrepancy in number of participants analyzed when compared to those who were randomized into the two arms of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise | Change in Functional Ability | Baseline | 58.55 units on a scale | Standard Deviation 13.46 |
| Aerobic Exercise | Change in Functional Ability | Week 12 | 60.64 units on a scale | Standard Deviation 9.89 |
| Balance and Stretching | Change in Functional Ability | Baseline | 67.83 units on a scale | Standard Deviation 5.42 |
| Balance and Stretching | Change in Functional Ability | Week 12 | 64.16 units on a scale | Standard Deviation 9.28 |
Secondary
Change in MCCB Scores
Cognitive function will be assessed by using the MATRICS Consensus Cognitive Battery (MCCB). It assesses seven key cognitive domains: processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB is a battery of tests with a computerized scoring system that produces T-scores, adjusted for age and sex, that are used by the MCCB software to create composite scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. A higher composite score on the MCCB is indicative of better cognitive function, however there are no clinically significant thresholds. The scores reported below are means +/- standard deviations of these composite scores.
Time frame: Baseline, 20 weeks
Population: We had significant drop out from baseline measurement to week 20, accounting for the difference in numbers when compared to the total enrolled. We also had two drop out in the Aerobic Exercise group between week 12 and week 20 accounting, which explains the difference in number between the primary outcome and this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise | Change in MCCB Scores | Baseline | 24.78 T-score | Standard Deviation 7.95 |
| Aerobic Exercise | Change in MCCB Scores | Week 20 | 29.33 T-score | Standard Deviation 8.12 |
| Balance and Stretching | Change in MCCB Scores | Baseline | 31.33 T-score | Standard Deviation 5.99 |
| Balance and Stretching | Change in MCCB Scores | Week 20 | 29.5 T-score | Standard Deviation 7.64 |
Secondary
Change in Scores on the University of California San Diego Performance-Based Skills Assessment (UPSA)
Functional ability will be assessed using the University of California San Diego Performance-Based skills assessment (UPSA). The UPSA is a measure of functional ability to perform common activities of daily living. It assess communication, financial, and household skills as well as the ability to manage medication, navigate transportation, and organize and plan an activity. Each measure creates a raw score which is summed to create a composite score. A higher score indicates better functional ability. No clinically significant thresholds. The maximum score an individual could obtain was 87 and the minimum was 0. The score is reported on scale units.
Time frame: Baseline, 20 weeks
Population: The numbers will differ from the initial secondary outcome because we had two individuals drop out of the study between the week 12 and week 20 assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise | Change in Scores on the University of California San Diego Performance-Based Skills Assessment (UPSA) | Week 20 | 64.33 units on a scale | Standard Deviation 7.6 |
| Aerobic Exercise | Change in Scores on the University of California San Diego Performance-Based Skills Assessment (UPSA) | Baseline | 57.66 units on a scale | Standard Deviation 14.11 |
| Balance and Stretching | Change in Scores on the University of California San Diego Performance-Based Skills Assessment (UPSA) | Week 20 | 67.33 units on a scale | Standard Deviation 8.21 |
| Balance and Stretching | Change in Scores on the University of California San Diego Performance-Based Skills Assessment (UPSA) | Baseline | 67.83 units on a scale | Standard Deviation 5.42 |