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Completed

NCT Number: NCT02621983

Aerobic Exercise for Cognition in Schizophrenia

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.

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Key information

Conditions

Schizophrenia Behavior Mental Disorders Motor Activity Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Behavioral

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.

Balance and Stretching

Behavioral

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 outcomes

  1. Change in Cognitive Function, Assessed by Scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)

    Time frame: 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 outcomes

  1. Change in Functional Ability

    Time frame: 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.

  2. Change in MCCB Scores

    Time frame: 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.

  3. Change in Scores on the University of California San Diego Performance-Based Skills Assessment (UPSA)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Emory University

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 4, 2015
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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