Back to resultsAerobic Exercise for Cognition in Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise
Balance and Stretching
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Exercise, Cognition
Eligibility Criteria
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
Sites / Locations
- Atlanta VA Medical and Rehab Center, Decatur, GA
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Aerobic Exercise
Balance and Stretching
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT02621983
First Posted
December 2, 2015
Last Updated
October 21, 2019
Sponsor
VA Office of Research and Development
Collaborators
Emory University
1. Study Identification
Unique Protocol Identification Number
NCT02621983
Brief Title
Aerobic Exercise for Cognition in Schizophrenia
Official Title
Aerobic Exercise for Cognition in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Exercise, Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Balance and Stretching
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Balance and Stretching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Cognitive Function, Assessed by Scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Description
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
Secondary Outcome Measure Information:
Title
Change in Functional Ability
Description
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
Title
Change in MCCB Scores
Description
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
Title
Change in Scores on the University of California San Diego Performance-Based Skills Assessment (UPSA)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica J. Duncan, MD
Organizational Affiliation
Atlanta VA Medical and Rehab Center, Decatur, GA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Aerobic Exercise for Cognition in Schizophrenia
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