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Aerobic Exercise for Cognition in Schizophrenia

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ClinicalTrials.gov Identifier: NCT02621983
Recruitment Status : Active, not recruiting
First Posted : December 4, 2015
Last Update Posted : July 19, 2018
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This study will evaluate the ability of aerobic exercise 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Aerobic Exercise Behavioral: Balance and Stretching Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aerobic Exercise for Cognition in Schizophrenia
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : July 1, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Behavioral: 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.

Active Comparator: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in cognitive function, assessed by scores on the 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 and composite scores.


Secondary Outcome Measures :
  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.

  2. Change in MCCB scores [ Time Frame: Baseline, 20 weeks ]
    Change in scores on the MCCB (Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery) assessing seven cognitive domains will be recorded.

  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02621983


Locations
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
VA Office of Research and Development
Emory University
Investigators
Principal Investigator: Erica J. Duncan, MD Atlanta VA Medical and Rehab Center, Decatur, GA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02621983     History of Changes
Other Study ID Numbers: D1897-P
1I21RX001897-01A1 ( U.S. NIH Grant/Contract )
IRB00082701 ( Other Identifier: IRB )
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by VA Office of Research and Development:
Schizophrenia
Exercise
Cognition

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders